ArticlePDF Available

Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder



Recent research suggests that psychedelic drugs can be powerful agents of change when utilized in conjunction with psychotherapy. Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been studied as a means of helping people overcome posttraumatic stress disorder, believed to work by reducing fear of traumatic memories and increasing feelings of trust and compassion toward others, without inhibiting access to difficult emotions. However,research studies for psychedelic psychotherapies have largely excluded people of color, leaving important questions unaddressed for these populations. At the University of Connecticut, we participated as a study site in a MAPS-sponsored, FDA-reviewed Phase 2 open-label multi site study, with a focus on providing culturally informed care to people of color. We discuss the development of a study site focused on the ethnic minority trauma experience,including assessment of racial trauma, design of informed consent documents to improve understanding and acceptability to people of color, diversification of the treatment team, ongoing training for team members, validation of participant experiences of racial oppression at a cultural and individual level, examination of the setting and music used during sessions for cultural congruence, training for the independent rater pool, community outreach, and institutional resistance. We also discuss next steps in ensuring that access to culturally informed care is prioritized as MDMA and other psychedelics move into late phase trials, including the importance of diverse sites and training focused on therapy providers of color.
Culturally informed research design issues in a study for MDMA-assisted
psychotherapy for posttraumatic stress disorder
Department of Psychology, University of Connecticut, Storrs, CT, USA
School of Psychology, University of Ottawa, Ottawa, ON, Canada
MAPS Public Benet Corporation, Santa Cruz, CA, USA
(Received: May 1, 2019; accepted: June 13, 2019)
Recent research suggests that psychedelic drugs can be powerful agents of change when utilized in conjunction with
psychotherapy. Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been studied as a means of
helping people overcome posttraumatic stress disorder, believed to work by reducing fear of traumatic memories and
increasing feelings of trust and compassion toward others, without inhibiting access to difcult emotions. However,
research studies for psychedelic psychotherapies have largely excluded people of color, leaving important questions
unaddressed for these populations. At the University of Connecticut, we participated as a study site in a MAPS-
sponsored, FDA-reviewed Phase 2 open-label multisite study, with a focus on providing culturally informed care to
people of color. We discuss the development of a study site focused on the ethnic minority trauma experience,
including assessment of racial trauma, design of informed consent documents to improve understanding and
acceptability to people of color, diversication of the treatment team, ongoing training for team members, validation
of participant experiences of racial oppression at a cultural and individual level, examination of the setting and music
used during sessions for cultural congruence, training for the independent rater pool, community outreach, and
institutional resistance. We also discuss next steps in ensuring that access to culturally informed care is prioritized as
MDMA and other psychedelics move into late phase trials, including the importance of diverse sites and training
focused on therapy providers of color.
Keywords: MDMA, race, methodology, PTSD, racial trauma, psychedelic
Posttraumatic stress disorder (PTSD) describes a constella-
tion of symptoms that can arise after experiencing or
witnessing a traumatic event. Individuals who have been
exposed to a traumatic event that causes a serious fear for
their own life or the lives of others is at risk of developing
PTSD, with those experiencing multiple traumas at higher
risk (Breslau, Chilcoat, Kessler, & Davis, 1999). People
typically affected include survivors of violent acts and
disasters, emergency responders to traumatic events, people
who experience the sudden death of a loved one, victims of
abuse, accident victims, and combat veterans (Kessler et al.,
However, many other events can be traumatic as well,
particularly to people of color (Williams, Printz, Ching, &
Wetterneck, 2018). African Americans, Hispanic/Latinx
Americans, and Native Americans are more likely to expe-
rience trauma related to experiences of police brutality,
community violence, racism, and poverty than their non-
Hispanic White counterparts (Pole, Gone, & Kulkarni,
2008;Williams, Printz, et al., 2018). Many immigrants and
refugees have PTSD from the impact of cultural trauma due
to ethnic cleansing and war, compounded by difcult
immigration experiences and adjustment-related stressors
(Bosson et al., 2017). Therefore, addressing the problem of
traumatization among these often marginalized ethnic
groups is an important goal for an equitable and healthy
The Multidisciplinary Association for Psychedelic Stud-
ies (MAPS) and MAPS Public Benet Corporation (MAPS
PBC) have been at the forefront of addressing PTSD by
working to make 3,4-methylenedioxymethamphetamine
(MDMA)-assisted psychotherapy into a legal prescription
medicine (Emerson, Ponté, Jerome, & Doblin, 2014). MAPS
is currently sponsoring Phase 3 clinical trials of MDMA as a
tool to assist psychotherapy for severe PTSD, with clinical
sites in the United States, Canada, and Israel. MDMA is also
known as ecstasyor molly,but those street drugs
frequently also contain unknown and/or dangerous adulter-
ants. In MDMA-assisted psychotherapy, pure MDMA is
administered only 23 times in conjunction with psychother-
apy, unlike most medications for mental illnesses, which are
often taken daily for several years (e.g., Mithoefer, Wagner,
Mithoefer, Jerome, & Doblin, 2011).
Studies suggest that MDMA can augment psycho-
therapeutic work to help improve symptoms of PTSD
* Corresponding author: Monnica T. Williams, PhD; School of
Psychology, University of Ottawa, 136 Jean-Jacques Lussier,
Vanier Hall, Ottawa, ON K1N 6N5, Canada; Phone: +1 613
562 5801; Fax: +1 613 562 5169; E-mail:
This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License,
which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and
source are credited, a link to the CC License is provided, and changes if any are indicated.
© 2019 The Author(s)
ORIGINAL ARTICLE Journal of Psychedelic Studies
DOI: 10.1556/2054.2019.016
(e.g., Mithoefer et al., 2018). MDMA reduces the fear of
traumatic memories and increases feelings of trust and
compassion toward others without causing sensory distor-
tions or inhibiting access to difcult emotions. As such,
MDMA can increase the effectiveness of psychotherapy by
making traumatic memories more accessible and strength-
ening the alliance between therapist and client, making it an
important and promising new intervention for the treatment
of PTSD. In August 2017, the US Food and Drug Admin-
istration (FDA) granted Breakthrough Therapy Designa-
tionto MDMA-assisted psychotherapy for the treatment of
PTSD. This indicates that the FDA believes, based on Phase
2 data, that MDMA-assisted psychotherapy may have an
advantage over existing medications for PTSD, and it
signals their intent to expedite the review process for a
New Drug Application for MDMA (Burns, 2017).
However, there are still large gaps in the body of knowl-
edge surrounding MDMA. Although many communities of
color experience the highest rates of PTSD leading to
prolonged suffering, disability, and poor quality of life
(e.g., Himle, Baser, Taylor, Campbell, & Jackson, 2009)
they are extremely underrepresented in psychedelic research
(Michaels, Purdon, Collins, & Williams, 2018;Williams &
Leins, 2016). People of color have not been adequately
included in previous studies of MDMA-assisted psychother-
apy to determine if the treatment is appropriate, safe, or
effective for them. Research has been conducted mostly with
White participant samples, limiting the generalizability of
safety and efcacy ndings for people of color, and leading
to their exclusion from MDMAs potential therapeutic ben-
ets (e.g., Herzberg & Butler, 2019). Thus, lack of diversity
is an important ethical concern (Sisti, 2018).
At the University of Connecticut Health Center (UConn),
our team participated in a MAPS-sponsored, Phase 2 open-
label multisite study for PTSD (MP-16), under the guidance
of the FDA. This site was the only one focused on the
recruitment of ethnoracial minority participants meeting
criteria for PTSD. The site protocol emphasized culturally
sensitive and respectful treatment approaches for people of
diverse backgrounds, considering the impact of cultural
differences and the possible need to adapt MDMA-assisted
psychotherapy to the needs and culturally specic traumas
experienced by people of color. In this study, we discuss
some of methodological changes that were made to help
ensure that the MDMA research was culturally sensitive and
Diversication of the treatment team
Several studies have documented to have adequate staff
members from diverse groups as key to successful efforts at
recruitment and retention of people of color (Williams,
Tellawi, Wetterneck, & Chapman, 2013). One reason for
this is that many people of color fear or feel uncomfortable
with the mental health system (U.S. Department of Health
and Human Services, 1999). Anecdotal reports from people
of color reveal fear and uncertainty from White therapists
over the ability to support the complexity of their emotional
experience, and indeed, several potential participants
expressed gratitude, safety, and comfort when interacting
with our therapists of color, as they had experienced dis-
connects with White clinicians in the past. It can make a
critical difference in participation, willingness, and overall
participant comfort when members of the research team
represent participant diversity. It makes the outcome of the
study more personally relevant when participants see others
like themselves invested in the research program and occu-
pying key leadership roles (e.g., Williams, Proetto, Casiano,
& Franklin, 2012), and participants may feel less worried
about experiencing racism when they see other people of
color involved. Furthermore, having clinicians from differ-
ent ethnic groups improves the ability of the team as a whole
to understand and appreciate issues relevant to a greater
number of potential participants.
At UConn, we intentionally made our research team as
diverse as possible. This included the Principal Investigator
(PI; an African American female psychologist), the co-PI (a
White American male psychiatrist), the study coordinator (an
African American female marriage and family therapist), the
study physician (an Indian American male), and three addi-
tional study therapists that included a Singaporean Chinese
male, biracial African American female, and a Hispanic
Asian American male. Our team was also diverse in terms
of sexual identity, age, religious beliefs, clinical training, and
therapeutic orientation. By sharing each others experience
and perspectives, this diversity enabled us to effectively work
with a range of clients with several different ethnic and
intersecting identities.
Outreach and recruitment
Most of the sites in the MAPS PBC MDMA-assisted
psychotherapy studies are contacted directly by prospective
participants as a result of information posted on the clinical
trials registry ( and e-mail announcements
from MAPS. However, these potential participants tend to
have a preexisting interest in the study due to something
they saw in the media or a previous connection with
psychedelic communities, which are, with few exceptions,
mostly White. As a result, the information about the study
was not being adequately disseminated to communities of
Although MAPS PBC, the designated clinical trial orga-
nizer, had preapproved language for recruitment materials,
as shown in Figure 1, it was inadequate for attracting people
of color. Unlike the White participants who were ooding
the study lines at all sites, our target audience required a
different approach, which included building trust, psychoe-
ducation, and gentle encouragement. The approved text did
not address the concerns of our participants of color, such as
fears of research abuse and safety of the drug. Due to our
countrys long history of research abuses against people of
color (Suite, La Bril, Primm, & Harrison-Ross, 2007),
minimal information could make potential participants
believe that study sponsors were hiding things from them
2|Journal of Psychedelic Studies
Williams et al.
and generate increased suspicion about the researchers
MAPS PBC was not amenable to investing time and funds
into creating new ads that would attract people of color when
the existing methods seemed to be generating more than
enough participants. To ll this gap, for the next phase of the
study, our site created its own yer to target these underrep-
resented groups, based on the literature and our own past
experience with minority outreach efforts. As shown in
Figure 2, the new ad included several vital elements including
(a) names and pictures of study staff; (b) diverse and
well-qualied team leaders; (c) psychoeducation about PTSD
and common causes of trauma among people of color;
(d) language addressing fears of death, disability, and addic-
tion; and (e) language about our sites culturally sensitive and
respectful treatment approach (Avery, Hernandez, & Hebl,
2004;Williams, Proetto, et al., 2012). Such ads can be used
for campus posters, public transportation, handouts, web
pages, and e-mail outreach.
However, ads alone are not usually sufcient to generate
adequate interest in a research study, particularly a poten-
tially controversial one that included a psychedelic drug.
The literature and our own experience indicated that word of
mouth from trusted sources is one of the most powerful
recruiting tools for research studies (Williams, Beckmann-
Mendez, & Turkheimer, 2013). As such, community out-
reach is an important part of a successful recruitment effort,
and study personnel can help by making and maintaining
personal connections with important people and organiza-
tions within communities of interest. At UConn, our team
gave several talks both on and off campus. On campus,
lectures were co-sponsored by Students for Sensible Drug
Policy who partnered with Collective Uplift, an organization
for student athletes of color. The topics of the talks were
intended to be engaging and relevant to students in these
organizations; lectures included From Microaggressions to
Hate Crimes: #RacialTraumaIsReal,given by the PI, and
MDMA-Assisted Psychotherapy: Our Experiences as Sub-
jects in an FDA-Approved Clinical Trial,given by two of
the study therapists who participated in a healthy volunteer
study sponsored by MAPS (e.g., Ching, in press). Each of
these talks generated a number of interested potential parti-
cipants of color from those who had attended the event as
well as interest from their friends and families. When giving
such talks, study personnel can provide yers for people to
take home and share, such as those in Figure 2.
It should be noted that some of the unsolicited e-mails we
received from participants were from people of color, but
there was no way to know this since most participants did
not disclose their race or ethnicity in their initial e-mails
to us. One strategy that helped was to include an auto-reply
e-mail that acknowledged receipt of the potential partici-
pants e-mail and asked them to respond by e-mail with
specic demographic information, including their race/
ethnicity, as well as other demographics such as age, city
of residence, and current medications. This strategy is cur-
rently in use at several of the Phase 3 sites to more efciently
identify racially and ethnically diverse participants.
People of color are more likely to be economically disad-
vantaged, making it more difcult to participate, as the time
spent in a research study may be outweighed by other
responsibilities, such as a job, school, or taking care of a
family (Fisher et al., 2002). Therefore, it is important to
provide meaningful and adequate compensation to partici-
pants for their time and to show appreciation for their
participation (Williams, Tellawi, et al., 2013). Furthermore,
friends and family members may be suspicious of research,
or in the case of mental health specically, consider it a
luxury, and pressure participants of color not to participate.
Incentives can help persuade others in the participants
circle that the participants time is being respected and the
study is worth conducting. Although there may be concerns
about increased study costs, the funds that go toward
compensating participants are actually a very small percent-
age of the study budget overall, and such incentives facili-
tate participation of low-income and economically disad-
vantaged individuals of all racial groups.
Because of the great interest by White participants,
initially there did not appear to be a need to nancially
compensate participants. However, we believe that all par-
ticipants should be fairly compensated as a matter of social
justice. That being said, payments that are too large can
amount to coercion and thus the appropriate amount should
be carefully considered (Grady, 2005). At certain approved
sites, MAPS was able to provide a total of $400 to
Do You Have Posttraumatic Stress Disorder (PTSD)?
Figure 1. Original IRB-approved ad for MDMA-assisted psychotherapy study for PTSD
Journal of Psychedelic Studies |3
Culturally informed research design in study of MDMA for PTSD
participants $100 for each overnight visit and $100 for the
independent rater assessments (This is explained in more
detail in the section Training for independent raters.). This
greatly facilitated participation as several of our participants
were low income or students. Compensation should be
provided in cash whenever possible, as a check can be a
dilemma if participants do not have checking accounts,
which was the case for some of our participants.
Figure 2. Sample recruitment yer. A colorful yer, originally designed for future Phase 3 studies, illustrates important design elements that
are key for attracting people of color
4|Journal of Psychedelic Studies
Williams et al.
Initial screening
For the initial screening, clinicians need to obtain detailed
information from potential participants by phone with very
little time to build rapport. Given that many participants of
color are mistrustful of the medical system, and even more
so a medical research study, extra effort needs to occur to
create trust. Often people of color have not felt respected or
been given the same courtesy that most of the White
participants have taken for granted in medical contexts
(Maina, Belton, Ginzberg, Singh, & Johnson, 2016), and
so they may be understandably wary of study clinicians.
Furthermore, people of color generally like to get to know
people before opening up, which can make it difcult to
elicit important trauma details at rst contact. Moreover,
people of color generally have a lower mental health
literacy, due to greater cultural stigmas about mental health;
therefore, study screening staff may need to provide psy-
choeducation about symptoms to aid in determining eligi-
bility (Cheng, Wang, McDermott, Kridel, & Rislin, 2018;
Williams, Domanico, Marques, Leblanc, & Turkheimer,
At the UConn site, we deliberately dedicated more time
to talking to potential participants during phone screenings.
Although this task was often performed by the study
coordinator at other sites, we shifted to having the potential
therapy providers make some of these calls to help them
build rapport sooner. Therapists spent more time explaining
PTSD symptoms to potential participants, or in some cases
translating their descriptions of symptoms into terminology
more consistent with DSM-5. Finally, therapists used this
opportunity to collect or conrm details about the persons
racial and ethnic identity to determine if the individuals
participation would help meet our sites critical diversity
Informed consent
The consent form is vitally important as it is a formal
description of what the study entails. However, sometimes
the document is misunderstood due to language that can be
unnecessarily off-putting or frightening. As such, a change
of language in consent forms was needed to make them
more palatable for people of color. For example, use of the
term researchwas minimized in favor of less triggering
terms such as projectand studyto distance these
recruitment efforts from associations with historical research
abuses against African Americans (Williams, Tellawi, et al.,
2013). For Latinx people, the word investigationcan be
triggering to those who face immigration stigma, so that was
similarly reworded. Experimental sessionwas changed to
overnight test sessionto eliminate terms that may make
participants further question their safety.
Researchers should also anticipate that more time will be
needed to review paperwork with participants. They should
make the process as conversational as possible to help put
participants at ease. Because the informed consent docu-
ment may resemble a contract, it is important to emphasize
that participants are not signing away their rights, but rather
the consent form exists to ensure that clinicians are doing
their jobs by providing complete information about what to
expect; participants are still free to withdraw at any time. As
researchers begin to create a shared language with partici-
pants, space opens for participants to ask more questions
about psychedelics, and this is a good opportunity to provide
this education about psychedelics and debunk any myths
they may believe.
It is important to review basic safety information, as that
will be one of the participants primary concerns. Partici-
pants of color are already wary for a number of reasons
previously discussed and do not want to hear extreme details
on everything that can go wrong they are already worried
about this and have decided to move forward anyway.
Their main concerns about MDMA are fears of death,
physical disability, mental disability, and addiction (Rigg
& Lawental, 2018), and so clinicians should focus on the
track record to date for MDMA in these areas. Here, it
would be important to give honest information that no one
who has taken MDMA in similar studies has died, become
disabled, or become addicted (e.g., the MDMA Investiga-
tors Brochure; Vizeli & Liechti, 2017). Giving exact
numbers helps promote trust and puts risks into perspective.
Setting and music
Set and setting refer to the non-drug factors, like mindset
and physical surroundings that shape psychedelic experi-
ences. People across cultures have been mindful of these
factors in psychedelic healing practices for a very long time
(Neitzke-Spruill, this issue). Therefore, it is critical to take
stock of the messages implicit in the setting provided for
participants. Individuals are part of a social context, which
refers to the immediate physical and social setting in which
people live or in which something happens or develops. It
includes the persons culture and the people and institutions
with whom they interact. Given the importance of social
context, there are many facets to be considered when
creating a comfortable space, which differs by culture.
Because of the deeply entrenched and pervasive racist
messages embedded in nearly every social structure, delib-
erate measures may be needed to create a welcoming venue.
For example, a lack of diversity in artwork, reading material,
and decorations may communicate threat to people of color
(e.g., Purdie-Vaughns, Steele, Davies, Ditlmann, & Crosby,
2008). When creating ambiance, clinicians should consider
the décor of the facility color schemes, choice of magazines,
and cultural ofce artwork can all be critically important in
making clients feel safe and welcome (Williams, Beckmann-
Mendez, et al., 2013).
A great deal of care and forethought went into the décor
of our study room at UConn, and input was solicited from all
members of the team. In terms of artwork, on one wall hangs
a framed print of a Latina mother holding her baby and on
another an impressionist map of the world in multicolor.
Other decorations include jade beads, a Tibetan sound bowl,
and colorful cotton throws and pillows with patterns from
India. As these decorations were reective of the varied
cultures of the team, they brought an element of cultural
authenticity to the milieu. However, as noted, setting
encompasses more than simply décor.
Since before the advent of Western psychedelic thera-
pies, music has played an important role within the
Journal of Psychedelic Studies |5
Culturally informed research design in study of MDMA for PTSD
therapeutic framework as a way to provide support through-
out the session (Bonny & Pahnke, 1972). There is growing
research to indicate that music can help facilitate psyche-
delic experiences that are benecial and important
therapeutically, and that listening to music while taking a
psychedelic medicine can evoke and intensify emotions
such as wonder, transcendence, power, tenderness, peace-
fulness, nostalgia, and joy (e.g., Kaelen, Roseman, Kahan,
Santos-Ribeiro, & Orban, 2016). In addition, music and
song are the integral part of many indigenous psychedelic
traditions (e.g., the icaros sung by shamanic healers during
the traditional ayahuasca ceremony; Labate & Pacheco,
2010;Tafur, 2017). In one study of 19 patients undergoing
psychedelic therapy with psilocybin for depression, analy-
ses revealed that the music had both welcome(desirable)
and unwelcome(aversive) inuences on the patients
experience (Kaelen, Giribaldi, Raine, & Evans, 2018). In
many cases, it evoked deeply meaningful, emotional, and
therapeutically valuable emotions and imagery. In some
cases, however, this was not the case; 6 out of 19 patients
referred to misguidanceand 9 out of 19 spoke to resis-
tanceas being a part of their experience at some point
(Kaelen et al., 2018). However, to date, no empirical
research has been conducted to examine the role of music
in psychedelic-assisted therapy with people of color.
Music is strongly connected to culture, and it makes
sense that music conducive to psychedelic healing for White
Americans may be inadequate for those from other cultural
traditions. Therefore, it is important to consider potential
alterations, supportive measures, or alternatives to the typi-
cal Western playlist (e.g., new age music, space music, folk,
post rock, etc.) that will better suit the individual needs of
each patient based on their preferences, safety needs, age,
and rich cultural background and heritage. At our site, we
carefully tailored the playlist to the relevant demographic
and cultural factors of our participants to help optimize their
experience. As psychedelic therapy expands from research
labs and into more clinics, we hope that more therapists will
explore novel ways of incorporating music into psychedelic
therapies with the diversity of individuals and cultural
groups in mind.
Training for team members
It is of the utmost importance that study personnel have a
genuine commitment to the mental health of people of color
and have been properly trained in culturally informed
assessment and treatment techniques. Although most new
clinicians are now receiving some sort of diversity education
in training programs to increase awareness, practical skills
may not have been included. In addition, previous genera-
tions of clinicians may have received no diversity training at
all, leaving them ill equipped to work with people of color.
At UConn, therapists were trained to take a multicultural
approach to treatment, whereby the differences, strengths,
and uniqueness of each ethnoracial group were embraced.
All therapists participated in an 8-week diversity training
where they learned to better understand and connect with
people of color using Functional Analytic Psychotherapy
(FAP; Tsai et al., 2009). Although FAP can be used as a
standalone treatment for relationship issues, it is typically
used in combination with other therapies to help increase
engagement and strengthen rapport. The FAP training pro-
vided an experiential approach for recognizing and combat-
ing personal biases, and therapists learned how to respond to
racially charged material in an empathetic rather than de-
fensive or dismissive manner (Miller, Williams, Wetterneck,
Kanter, & Tsai, 2015). Therapists were also educated on
microaggressions, including how to recognize and manage
them in interactions. These trainings did not replace the non-
directive, inner focused therapy that was required as per the
MAPS PBC study protocol (Mithoefer, 2015), but rather
augmented that approach.
Through a justice-oriented framework, our therapists
provided an environment of openness, curiosity, and vali-
dation for our participantsracialized experiences. This
included expressing empathy for experiences of racism and
marginalization with verbal and non-verbal cues. It also
included validating any mistrust of the research process, and
acknowledgment of historical research abuses against peo-
ple of color. All therapists were well aware of structural
racism typically embedded in current research processes and
vocalized their commitment to doing things differently. As
part of the conversation during initial visits, our therapists
might say something like, One reason this site is committed
to working with people of color is because almost all
research to date has been done with White people. They
have been getting this treatment for years, and its time that
people like us are included too. Otherwise, how do we even
know if this treatment makes sense for us and our communi-
ties? Your involvement will help move this work forward for
everyone, and in the process you will receive a culturally-
informed treatment experience.
Finally, cultural humility was emphasized throughout.
Despite the diversity of our team, we could not be equipped
for every ethnic and cultural group that contacted us, so we
needed to be sure not to ever become complacent in our
efforts or stop learning. Cultural humility is an approach that
communicates attentiveness and interest in the other person,
marked by openness, curiosity, lack of arrogance, and
genuine desire to understand clientscultural identities
(Mosher et al., 2017). Therapists with high levels of cultural
humility rarely assume competence, but rather approach
clients with respectful openness and collaboratively explore
the clients cultural identities. In this regard, cultural com-
petence should be viewed as a journey, not a destination, as
we are always becoming more culturally competent while
never actually achieving cultural competence. Cultural com-
petence is a dynamic ever-changing and ever-challenging
lifelong process (Yeager & Bauer-Wu, 2013).
Assessing racial trauma
When traumatization results from experiences of racism, it
is sometimes called racial trauma. It can be caused by
major experiences of racism such as workplace harassment
or police brutality, or it can be the result of an accumulation
of many small occurrences, such as everyday discrimina-
tion and microaggressions (e.g., Williams, Kanter, &
Ching, 2018). One difculty is that clinicians may only
recognize racism as trauma when an individual experiences
a specic racist event, such as a violent hate crime
6|Journal of Psychedelic Studies
Williams et al.
(Malcoun, Williams, & Bahojb-Nouri, 2015). This is limiting
given that many people of color experience cumulative
experiences of racism as traumatic (Butts, 2002). In addition,
people of color may not share experiences of discrimination
when asked about traumas they may have experienced unless
they are told explicitly that racism counts as a trauma
(Williams, Metzger, Leins, & DeLapp, 2018).
To ensure that traumas due racism and to other forms
of oppression were captured, a modied version of the
UConn Racial/Ethnic Stress & Trauma Survey (UnRESTS;
Williams, Metzger, et al., 2018) was added to the source
documents used for collecting information about participants
by study therapists. The UnRESTS is a semi-structured
interview designed to assess racial trauma in clients who are
part of stigmatized ethnic and racial groups. The UnRESTS
collects information about a clients ethnic identity and then
guides the clinician to ask about experiences surrounding:
(a) explicit and obvious racism, (b) discrimination experi-
enced by loved ones, (c) vicarious prejudicial experiences
that were learned about, and (d) experiences with subtle forms
of racism or microaggressions. The scope of the measure was
broadened to include other types of discrimination, including
gender, sexual orientation, age, disability, faith, or a combi-
nation of reasons,and it was shortened from its original
length to minimize participant burden. This information is
also provided to the independent raters so they know about
the participantsexperiences as well. Feedback from clin-
icians at various MAPS PBC study sites found the measure
easy to use and useful in better understanding their partici-
pantshistories of racial trauma and other forms stigmatiza-
tion. Even in cases where experiences of discrimination did
not meet DSM-5 Criterion A, the information was useful for
better understanding participantslived experiences (see
Supplementary Materialfor the short version of the
Training for independent raters
The independent raters for the MDMA-assisted psychother-
apy for PTSD study are gatekeepers in a sense, as they
quantify the PTSD diagnosis for participants, which must
meet a certain threshold before being allowed to enroll.
Using the gold standard in PTSD research, the Clinicians
Administered PTSD Scale (Weathers et al., 2013), the
independent rater group is a pool of highly trained clinicians
who are not present during therapy to minimize bias during
outcome measurements.
As with study therapy providers, participants of color
may not initially trust raters, thereby requiring raters to
develop a quick positive rapport with participants, so they
feel safe enough to disclose their traumas. Furthermore,
raters needed to be able to identify sources of trauma related
to the experience of racial discrimination and related forms
of oppression. However, the vast majority of MAPS PBC
independent raters were White and many had inadequate
training in working with people of color. Since the study
design required that participants receive their rater from the
pool randomly, it was not possible to provide an ethnic
match for participants of color or even make a rater recom-
mendation to ensure that the clinician was well-trained in
working with people of color.
To address these issues, more raters of color were hired
and all raters received a diversity training designed in part
by the rst author (MTW) to better assess clients across
racial, ethnic, and cultural differences. This included regular
meetings online as a group where raters were provided
readings and presentations on the topics of ethnic identity
development, therapeutic distance based on ethnic identity;
models of acculturation; Whiteness and privilege; racism
and microaggressions; racial trauma, personality disorders,
and culture; and cultural issues surrounding the use of study
measures. These trainings were video-recorded and are now
required viewing for MAPS PBC therapy providers partici-
pating in Phase 3 studies, which extends the benets of this
training study-wide. In addition, two short quizzes were
developed by the third author (RA) that allowed therapy
providers to reect on the material presented.
Independent raters also completed challenging experien-
tial homework exercises designed to facilitate a shift in
thinking from an ethnocentric to a multicultural perspective.
This involved practicing mutually reciprocal interactions
with others across race, practicing giving the UnRESTS,
self-reection, and sharing challenges in the group. Similar
techniques have been empirically shown to improve client-
clinician interactions (Rosen et al., 2018). The raters learned
much from this training and felt better equipped to work
with diverse participants (see Supplementary Materials
for questions used to help assess rater cultural competency).
Even so, this situation was not perfect a Caribbean woman
who was selected to be a part of the trial dropped out of
screening because she did not receive a Black woman as her
Institutional resistance
Despite initial displays of enthusiasm about the study by
university leadership, there was some fear and misunder-
standing surrounding safety issues related to MDMA. This
led to unreasonable levels of precaution, far greater than
warranted based on MDMAs safety record and exceeding
what was required by the FDA. Although the study was
designed and approved for an outpatient setting, the institu-
tionsOfce of the Vice President of Research (OVPR)
insisted the study to take place in the hospital, which added
greatly to the level of bureaucracy, complexity of study
billing, and study costs (Lekhtman, 2018). On several
occasions, the health center demanded the employment of
a nurse as a night attendant instead of a volunteer, as is
typically done at other study sites. We opted to use a clinical
graduate student as a night attendant (with the study physi-
cian and PI on call), as a nurse was unnecessary and would
have been cost prohibitive.
There was notable structural, institutional, and individual
racism that also impeded the work, as well as bureaucratic
obstacles. This included untenable delays in hiring essential
personnel, including 5 months to ofcially hire the study
coordinator. The PI had to meet with the OVRP and the
Chief Diversity Ofcer to overcome this resistance, and
once hired, the institution refused to provide the study
coordinator with her back pay, even though the sponsor
had already provided these funds to the university. We were
able to resolve this by having the sponsor pay the study
Journal of Psychedelic Studies |7
Culturally informed research design in study of MDMA for PTSD
coordinator to back pay directly. Other barriers included
refusal to provide promised billing services, refusal to give
prescribing privileges to our teams psychiatrist (a Harvard-
trained MDPhD), twice having our study space given away
to another research team, study staff being harassed by
nurses for not belongingin our research space, an aggres-
sive audit of the study that took 2 months of staff time (and
included several inaccurate ndings of misconduct that were
later withdrawn), opposing the PIs plans to move the study
to a more collegial health center division, and inappropriate
threats by the OVPR for exploring the possibility of moving
the study off-campus.
In terms of sexism, female clinicians felt ignored and not
taken seriously by health center staff and UConn leadership.
For example, there were several meetings by chairs, deans,
and vice presidents about study issues and in every case the
female PI (MTW) was not invited, despite repeated requests
for inclusion; rather she was informed about decisions
impacting the study after the fact, without the benetof
her knowledge and input at those meetings.
There were other problematic issues as well, such as
higher than normal charges by the health center for medical
procedures, in some cases three times the typical rate
(e.g., the health center charged the sponsor $3,820 for a
nuclear stress test while charging Anthem only $837 for this
same test). In this case, we were able to contract with a less
expensive outside clinic for needed cardiac tests.
Implications for Phase 3 trials
In this study, we have outlined several key issues and
strategies surrounding participation and retention of people
of color into MDMA-assisted psychotherapy studies. Im-
portant considerations include a diverse study staff, pur-
poseful training in cultural competence for therapists and
raters, targeted outreach for recruitment, meaningful incen-
tives, a comfortable setting, and competent assessment of
racial trauma. Critical discussion on limitations and obsta-
cles to recruiting diverse populations is important to conduct
during protocol development. It is worth noting that involv-
ing someone with expertise in culturally informed research
methods at the front end, before protocols were developed,
would have prevented some of the methodological issues
that needed to be changed after the fact. There is also a
need to confront institutional and individual biases that may
work against inclusion, as racism and sexism are embedded
into nearly all institutional structures and systems (Salter,
Adams, & Perez, 2018). For example, currently, MAPS
PBC staff includes only 4 people of color out of 26.
Recognizing the benets of a diverse staff, the organization
is in the process of hiring with the intention of increasing
diversity, particularly in the upper echelons of the
The methods described herein were effective for recruit-
ment and retention at our site in Connecticut but each
community has its own differences and nuances, which will
require an ongoing review of efforts to determine if diversity
goals are being met. Holding regular team meetings to
review enrollment rates versus targeted enrollment numbers
can inform team leaders as to if diversity goals are being
met. A self-correcting process should be implemented
whereby methods that are not effective are reduced and
those that are effective are retained or increased (Clay, Ellis,
Amodeo, Fassler, & Grifn, 2003).
MAPS PBC is currently running Phase 3 trials, and
although the UConn site was not included due to lack of
adequate institutional support at the health center (Lekhtman,
2018), many of the modications made to study protocols
continue to benet other sites and the study as a whole, such
as the changes to consent forms, trainings for raters, and
training materials for therapy providers. However, people of
color are underrepresented as clinicians at most sites, so work
is still needed to make participants of color feel included,
welcome, safe, and understood. As a result, there may be less
than representative proportions of participants from various
ethnoracial groups in the nal sample. If the nal Phase 3
sample does not contain enough patients of color for mean-
ingful subgroup analyses, an additional study focused on
people of color would be an important next step to help
determine the safety and efcacy of MDMA-assisted psy-
chotherapy for people in underrepresented racial and ethnic
Expanded Access
Expanded Access is an FDA program that allows the use of
an investigational drug under an approved treatment proto-
col. The program is designed to address urgent and life-
threatening conditions in patients who do not adequately
respond to available treatment options. MAPS PBC has
recently applied for the Expanded Access program and
hopes for approval in 2019. If Expanded Access is ap-
proved, new sites in the US will be able to participate in their
Expanded Access protocol, which would allow the provi-
sion of open-label MDMA-assisted psychotherapy for
PTSD. Qualied sites will be required to have a team of
therapy providers, a physician, a study coordinator, and a
facility suitable to conduct MDMA-assisted psychotherapy,
with approval by regulatory agencies and under supervision
of MAPS PBC. Furthermore, therapy providers must be
trained through the MAPS Therapy Training Program to be
eligible to provide therapy, and this training and supervision
process costs approximately $9,000 per therapist. Expanded
Access clinics can utilize the methods described here to
increase inclusion of patients of color. That being said, due
to the extensive site and provider requirements, the cost for
an entire course of treatment will be unaffordable for many
people (current estimates are approximately $15,000), and
so work is needed to make this treatment accessible to those
with limited nancial means.
As of 2018, MAPS PBC trained 221 MDMA therapists,
and only 22 (<10%) of these are therapy providers of color,
which included international therapy providers. More thera-
pists of color are sorely needed to bring MDMA treatment to
communities of color during the Expanded Access period
and thereafter. To this end, MAPS PBC is co-sponsoring an
MDMA therapy training for communities of color, grant-
funded by Open Society Foundations, Riverstyx Founda-
tion, Libra Foundation, and others sponsors. This training
8|Journal of Psychedelic Studies
Williams et al.
will equip therapists and inform community leaders of color
about this new modality and its ability to reduce symptoms
of PTSD, with a focus on culturally informed psychedelic
therapy. In the process of developing this training, the
standard MAPS PBC trainings will also benet, as many
culturally informed updates will be available to add into it.
In addition to the standard 6.5-day training, this special
training will feature a 1.5-day opening workshop entitled,
Psychedelic Medicine and Cultural Trauma.Community
leaders will join therapy providers to engage in dialogue
about the social, political, cultural, and historical causes of
trauma, as well as a history of indigenous practices of
healing with plant medicines. This workshop will discuss
barriers to acceptance of MDMA therapy in communities of
color and potential ways forward. Most importantly, this
training will help build a community of color dedicated to
bringing MDMA therapy to communities to support its
members to both ourish and expand.
Future psychedelic therapists
Leaders in the eld of psychedelic medicine are working to
develop credentialing boards to implement the therapeutic
competencies needed to work responsibly with MDMA
and other psychedelic substances. Because of the impor-
tance of this work and the extreme vulnerability of patients
during non-ordinary states of consciousness, all therapy
providers and supervisors should have basic competencies
in working ethically and skillfully with people of color
(Phelps, 2017;Sisti, 2018). These essential skills include
the ability to (a) understand normal cultural variations in
the expression of psychopathology and personality traits;
(b) identify trauma related to the experience of racial
discrimination, ethnic violence, xenophobia, and other
forms of oppression; (c) develop good rapport with people
of color by appropriately expressing caring, empathy, and
respect; (d) comfortably engage in discussions about ra-
cially charged topics; and (e) identify and describe their
own biases as they relate to ethnic and racial differences,
with an ongoing action plan to address these. All therapy
providers conducting psychedelic therapies should be
trained and tested in these areas prior to certication (also
see Supplementary materialsfor assessing cultural
A culturally informed approach in psychedelic therapies can
and should be used in the research process to ensure equity
and diversity in access to the potential benets of MDMA.
Current processes for recruitment and treatment are not
sufcient to open the doors of psychedelic therapies to
people of color in the US or internationally (Michaels
et al., 2018). MAPS has been a leader in conducting research
into MDMA-assisted therapy and to our knowledge has
been the rst to make a deliberate effort to include of people
of color in the work. Still more work is needed and
hopefully this trajectory of inclusion will continue as other
groups begin the work of ensuring that psychedelic research
meets the needs of everyone.
Acknowledgements: The authors would like to thank Mul-
tidisciplinary Association for Psychedelic Studies (MAPS)
for support of the study An Open-Label, Multi-Site Phase 2
Study of the Safety and Effect of Manualized MDMA-
Assisted Psychotherapy for the Treatment of Severe Post-
traumatic Stress Disorder (MP-16).They would also
acknowledge the Open Society Foundations (OSF), Libra
Foundation, Riverstyx Foundation, and others for grant
funding for MDMA Therapy Training for Communities of
Color.In addition, they would acknowledge Chad Wetter-
neck for providing diversity training and materials for the
MAPS rater pool, Alli Feduccia for her comments on the
manuscript, and Jennifer Purdon for help with the literature
Conict of interest: All authors report no conicts of
Avery, D. R., Hernandez, M., & Hebl, M. R. (2004). Whos
watching the race? Racial salience in recruitment advertising.
Journal of Applied Social Psychology, 34(1), 146161.
Bonny, H. L., & Pahnke, W. N. (1972). The use of music in
psychedelic (LSD) psychotherapy. Journal of Music Therapy,
9(2), 6487. doi:10.1093/jmt/9.2.64
Bosson, R., Williams, M. T., Lippman, S., Carrico, R., Kanter, J.,
Pe˜na, A., Mier-Chairez, J., & Ramirez, J. (2017). Addressing
refugee mental health needs: From concept to implementation.
The Behavior Therapist, 40(3), 110112.
(1999). Previous exposure to trauma and PTSD effects of
subsequent trauma: Results from the Detroit Area Survey of
Trauma. American Journal of Psychiatry, 156(6), 902907.
Burns, J. (2017, August 28). FDA designates MDMA as Break-
through Therapyfor post-traumatic stress. Forbes. Re-
trieved from
Butts, H. F. (2002). The black mask of humanity: Racial/
ethnic discrimination and post-traumatic stress disorder. The
Journal of the American Academy of Psychiatry and the Law,
30, 336339.
Cheng, H., Wang, C., McDermott, R. C., Kridel, M., & Rislin, J. L.
(2018). Self-stigma, mental health literacy, and attitudes
toward seeking psychological help. Journal of Counseling
& Development, 96(1), 6474. doi:10.1002/jcad.12178
Ching, T. H. W. (in press). Intersectional insights from an MDMA-
assisted psychotherapy training trial: An open letter to racial/
ethnic and sexual/gender minorities. Journal of Psychedelic
Clay, C., Ellis, M. A., Amodeo, M., Fassler, I., & Grifn, M. L.
(2003). Families in society: Recruiting a community sample of
African American subjects: The nuts and bolts of a successful
effort. Families in Society, 84(3), 396404. doi:10.1606/1044-
Journal of Psychedelic Studies |9
Culturally informed research design in study of MDMA for PTSD
Emerson, A., Ponté, L., Jerome, L., & Doblin, R. (2014). History
and future of the Multidisciplinary Association for Psychedelic
Studies (MAPS). Journal of Psychoactive Drugs, 46(1),
2736. doi:10.1080/02791072.2014.877321
Fisher, C. B., Hoagwood, K., Boyce, C., Duster, T., Frank, D. A.,
Grisso, T., Levine, R. J., Macklin, R., Spencer, M. B., Taka-
nishi, R., Trimble, J. E., & Zayas, L. H. (2002). Research ethics
for mental health science involving ethnic minority children
and youth. American Psychologist, 57, 10241039.
Grady, C. (2005). Payment of clinical research subjects. The
Journal of Clinical Investigation, 115(7), 16811687.
Herzberg, G., & Butler, J. (2019, March 13). Blinded by the
White: Addressing power and privilege in psychedelic medi-
cine. Chacruna. Retrieved from
Himle, J. A., Baser, R. E., Taylor, R. J., Campbell, R. D., &
Jackson, J. S. (2009). Anxiety disorders among African
Americans, Blacks of Caribbean descent, and non-Hispanic
Whites in the United States. Journal of Anxiety Disorders,
23(5), 578590. doi:10.1016/j.janxdis.2009.01.002
Kaelen, M., Giribaldi, B., Raine, J., & Evans, L. (2018). The
hidden therapist: Evidence for a central role of music in
psychedelic therapy. Psychopharmacology, 235(2), 505519.
Kaelen, M., Roseman, L., Kahan, J., Santos-Ribeiro, A., & Orban,
C. (2016). LSD modulates music-induced imagery via changes
in parahippocampal connectivity. European Neuropsycho-
pharmacology, 26(7), 10991109. doi:10.1016/j.euroneuro.
Kessler, R. C., Aguilar-Gaxiola, S., Alonso, J., Benjet, C., Bromet,
E. J., Cardoso, G., Degenhardt, L., de Girolamo, G., Dinolova,
R. V., Ferry, F., Florescu,S., Gureje, O., Haro, J. M., Huang, Y.,
Karam, E. G., Kawakami, N., Lee, S., Lepine, J. P.,
Levinson, D., Navarro-Mateu, F., Pennell, B. E., Piazza, M.,
Posada-Villa, J., Scott, K. M., Stein, D. J., Ten Have, M.,
Torres, Y., Viana, M. C., Petukhova, M. V., Sampson, N. A.,
Zaslavsky, A. M., & Koenen, K. C. (2017). Trauma and PTSD
in the WHO World Mental Health Surveys. European Journal
of Psychotraumatology, 8(Suppl. 5), 1353383. doi:10.1080/
Labate, B. C., & Pacheco, G. (2010). Opening the portals of
heaven: Brazilian Ayahuasca music. Munich, Germany: Lit
Lekhtman, A. (2018, December 18). Pioneering UConn MDMA
research focused on people of color ends early: What are
the next steps for equity in treatment? Psychedelic Times.
Retrieved from
Maina, I. W., Belton, T. D., Ginzberg, S., Singh, A., & Johnson,
T. J. (2016). A decade of studying implicit racial/ethnic bias in
healthcare providers using the implicit association test.
Social Science and Medicine, 199, 219229. doi:10.1016/j.
Malcoun, E., Williams, M. T., & Bahojb-Nouri, L. V. (2015).
Assessment of Posttraumatic Stress Disorder in African Amer-
icans. In L. T. Benuto & B. D. Leany (Eds.), Guide to
psychological assessment with African Americans
(pp. 163182). New York, NY: Springer.
Michaels, T. I., Purdon, J., Collins, A., & Williams, M. T. (2018).
Inclusion of people of color in psychedelic-assisted psycho-
therapy: A review of the literature. BMC Psychiatry, 18(245),
19. doi:10.1186/s12888-018-1824-6
Miller, A., Williams, M. T., Wetterneck, C. T., Kanter, J., & Tsai, M.
(2015). Using functional analytic psychotherapy to improve
awareness and connection in racially diverse client-therapist
dyads. The Behavior Therapist, 38(6), 150156.
Mithoefer, M. C. (2015, August). A manual for MDMA-assisted
psychotherapy in the treatment of posttraumatic stress disorder,
Version 7: 19. Santa Cruz, CA: Multidisciplinary Association
for Psychedelic Studies (MAPS). Retrieved from https://maps.
Mithoefer, M. C., Mithoefer, A. T., Feduccia, A. A., Jerome, L.,
Wagner, M., Wymer, J., Holland, J. T., Hamilton, S., Yazar-
Klosinski, B., Emerson, A. B., & Doblin, R. (2018). 3,
4-Methylenedioxymethamphetamine (MDMA)-assisted psycho-
therapy for post-traumatic stress disorder in military veterans,
reghters, and police ofcers: A randomised, double-blind,
dose-response, phase 2 clinical trial. The Lancet Psychiatry,
5(6), 486497. doi:10.1016/S2215-0366(18)30135-4
Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., &
Doblin, R. (2011). The safety and efcacy of ±3,
4-methylenedioxymethamphetamine-assisted psychotherapy
in subjects with chronic, treatment-resistant posttraumatic
stress disorder: The rst randomized controlled pilot study.
Journal of Psychopharmacology, 25(4), 439452. doi:10.1177/
Mosher, D. K., Hook, J. N., Captari, L. E., Davis, D. E., DeBlaere,
C., & Owen, J. (2017). Cultural humility: A therapeutic
framework for engaging diverse clients. Practice Innovations,
2(4), 221233. doi:10.1037/pri0000055
Phelps, J. (2017). Developing guidelines and competencies for the
training of psychedelic therapists. Journal of Humanistic Psy-
chology, 57(5), 450487. doi:10.1177/0022167817711304
Pole, N., Gone, J. P., & Kulkarni, M. (2008). Posttraumatic stress
disorder among ethnoracial minorities in the United States.
Clinical Psychology: Science and Practice, 15(1), 3561.
Purdie-Vaughns, V., Steele, C. M., Davies, P. G., Ditlmann, R., &
Crosby, J. R. (2008). Social identity contingencies: How
diversity cues signal threat or safety for African Americans
in mainstream institutions. Journal of Personality and Social
Psychology, 94(4), 615630. doi:10.1037/0022-3514.94.4.615
Rigg, K. K., & Lawental, M. (2018). Perceived risk associated with
MDMA (Ecstasy/Molly) use among African Americans: What
prevention and treatment providers should know. Substance
Use & Misuse, 53(7), 10761083. doi:10.1080/10826084.
Rosen, D. C., Kanter, J. W., Manbeck, K., Branstetter, H., Corey,
M. D., Williams, M. T., & Masuda, A. (2018, July). A
contextual-behavioral intervention to improve provider empa-
thy and emotional rapport in racially charged interactions: A
randomized trial. In M. D. Corey (Chair), Applying CBS to
address social divisions. Symposium presentation at ACBS
World Conference 16, Montréal, Québec.
Salter, P. S., Adams, G., & Perez, M. J. (2018). Racism in the
structure of everyday worlds: A cultural-psychological per-
spective. Current Directions in Psychological Science, 27(3)
150155. doi:10.1177/0963721417724239
10 |Journal of Psychedelic Studies
Williams et al.
Sisti, D. (2018). Creating an ethical framework for psychedelic
therapy research. Multidisciplinary Association for Psychedel-
ic Studies (MAPS) Bulletin, 28(3), 3435.
Suite, D. H., La Bril, R., Primm, A., & Harrison-Ross, P. (2007).
Beyond misdiagnosis, misunderstanding and mistrust: Rele-
vance of the historical perspective in the medical and mental
health treatment of people of color. Journal of the National
Medical Association, 99(8), 879885.
Tafur, J. (2017). Fellowship of the river. Pheonix, AZ: Espirito
Tsai, M., Kohlenberg, R. J., Kanter, J. W., Kohlenberg, B.,
Follette, W. C., & Callaghan, G. M. (2009). A guide to
functional analytic psychotherapy: Awareness, courage, love,
and behaviorism. New York, NY: Springer.
U.S. Department of Health and Human Services. (1999). The
fundamentals of mental health and mental illness, Ch 2. In
Mental health: A report of the surgeon general. Rockville,
MD: U.S. Department of Health and Human Services, Sub-
stance Abuse and Mental Health Services Administration,
Center for Mental Health Services, National Institutes of
Health, National Institute of Mental Health.
Vizeli, P., & Liechti, M. E. (2017). Safety pharmacology of acute
MDMA administration in healthy subjects. Journal of Psycho-
pharmacology, 31(5), 576588. doi:10.1177/0269881117691569
Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G.,
Marx, B. P., & Keane, T. M. (2013). The clinician-
administered PTSD scale for DSM-5 (CAPS-5). Interview
retrievedfrom the National Center for PTSD at
Williams, M. T., Beckmann-Mendez, D., & Turkheimer, E. (2013).
African American attitudes about participation in anxiety dis-
orders research. Journal of the National Medical Association,
105(1), 3341. doi:10.1016/S0027-9684(15)30083-3
Williams, M. T., Domanico, J., Marques, L., Leblanc, N., &
Turkheimer, E. (2012). Barriers to treatment among African
Americans with obsessive-compulsive disorder. Journal of
Anxiety Disorders, 26(4), 555563. doi:10.1016/j.janxdis.
Williams, M. T., Kanter, J. W., & Ching, T. H. W. (2018). Anxiety,
stress, and trauma symptoms in African Americans: Negative
affectivity does not explain the relationship between micro-
aggressions and psychopathology. Journal of Racial and
Ethnic Health Disparities, 5(5), 919927. doi:10.1007/
Williams, M. T., & Leins, C. (2016). Race-based trauma: The
challenge and promise of MDMA-assisted psychotherapy.
Multidisciplinary Association for Psychedelic Studies (MAPS)
Bulletin, 26(1), 3237.
Williams, M. T., Metzger, I., Leins, C., & DeLapp, C. (2018).
Assessing racial trauma within a DSM-5 framework: The
UConn Racial/Ethnic Stress & Trauma Survey. Practice Inno-
vations, 3(4), 242260. doi:10.1037/pri0000076
Williams, M. T., Printz, D., Ching, T., & Wetterneck, C. T. (2018).
Assessing PTSD in ethnic and racial minorities: Trauma and
racial trauma. Directions in Psychiatry, 38(3), 179196.
Williams, M. T., Proetto, D., Casiano, D., & Franklin, M. E.
(2012). Recruitment of a hidden population: African
Americans with obsessive-compulsive disorder. Contemporary
Clinical Trials, 33(1), 6775. doi:10.1016/j.cct.2011.09.001
Williams, M. T., Tellawi, G., Wetterneck, C. T., & Chapman, L. K.
(2013). Recruitment of ethnoracial minorities for mental health
research. The Behavior Therapist, 36(6), 151156.
Yeager, K. A., & Bauer-Wu, S. (2013). Cultural humility: Essential
foundation for clinical researchers. Applied Nursing Research,
26(4), 251256. doi:10.1016/j.apnr.2013.06.008
Journal of Psychedelic Studies |11
Culturally informed research design in study of MDMA for PTSD
... Kenneth (pseudonym) used alcohol and cannabis to cope with intrusive memories of these experiences, often drinking to the point of passing out. He received culturally informed MDMA-assisted therapy, which enabled him to gain new insights into his trauma and process his emotions associated with it (Williams et al., 2020a). This enabled Kenneth to feel more connected to himself and others and develop healthier coping strategies for managing distress in the future. ...
... Set and setting are inherently cultural, and as such, it is important to create an atmosphere that is safe and supportive, free from judgment or bias, especially for people of color (Fogg et al., 2021;Neitzke-Spruill, 2020). In addition, the environment should reflect comforting elements of the cultural backgrounds of those being treated by incorporating symbols, art, and language from their culture (Williams et al., 2020a). • Diversification within the psychedelic space is critical and cannot be overstated. ...
... • Diversification within the psychedelic space is critical and cannot be overstated. This includes not only representation among clinicians, researchers, and other professionals in this field but also ensuring access to psychedelics for people of color who may face unique barriers due to systemic racism (e.g., racial trauma, discrimination, and poverty; Michaels et al., 2018;Williams et al., 2020a). A diversity of psychedelic providers is essential for those seeking to work with someone from their own ethnic or racial community (Buchanan, 2021). ...
Full-text available
Psychedelics are being studied for the treatment of numerous mental health disorders, as well as a means of bringing people together. Nonetheless, people of color and those with other marginalized identities have not been fully included. Studies and research on psychedelic-assisted therapies have largely excluded people of color, leaving out fundamental clinical issues for these populations. This paper provides a narrative review of relevant research on this topic, racial trauma, ethnic minority mental health, and how psychedelic therapies can advance recovery for people of color. It also discusses potential harms and steps needed to promote culturally inclusive access to care. Many psychedelic therapy trials are in their final stages and access is being expanded, making it important to consider equitable practices in research that can foster inclusion, such as community-based participatory research and culturally informed research design.
... Among 1529 potential participants who completed prescreening, 347 signed informed consent, 240 were excluded at screening, 3 were excluded prior to randomization, and 104 were randomized, received the study drug, and comprised the ITT population (51 in the psilocybin group and 53 in the niacin group) (Figure 1). Median (IQR) time between enrollment and randomization on the morning of dosing was comparable for the 2 groups (28 [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] days for psilocybin and 28 [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] days for niacin). Enrollment by study site is detailed in eTable 1 in Supplement 3. ...
... Whether psilocybin would be more, less, or equivalently effective in a more ethnically, racially, and socioeconomically diverse sample is an urgent question that must be addressed in future studies by actively employing strategies shown to increase recruitment and retention of racial and ethnic minoritized populations and other underrepresented groups in clinical trials of psychedelic agents. 36 ...
Importance: Psilocybin shows promise as a treatment for major depressive disorder (MDD). Objective: To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD. Design, setting, and participants: In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were randomized in a 1:1 ratio to receive a single dose of psilocybin vs niacin placebo administered with psychological support. Participants were adults aged 21 to 65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of MDD of at least 60 days' duration and moderate or greater symptom severity. Exclusion criteria included history of psychosis or mania, active substance use disorder, and active suicidal ideation with intent. Participants taking psychotropic agents who otherwise met inclusion/exclusion criteria were eligible following medication taper. Primary and secondary outcomes and adverse events (AEs) were assessed at baseline (conducted within 7 days before dosing) and at 2, 8, 15, 29, and 43 days after dosing. Interventions: Interventions were a 25-mg dose of synthetic psilocybin or a 100-mg dose of niacin in identical-appearing capsules, each administered with psychological support. Main outcomes and measures: The primary outcome was change in central rater-assessed Montgomery-Asberg Depression Rating Scale (MADRS) score (range, 0-60; higher scores indicate more severe depression) from baseline to day 43. The key secondary outcome measure was change in MADRS score from baseline to day 8. Other secondary outcomes were change in Sheehan Disability Scale score from baseline to day 43 and MADRS-defined sustained response and remission. Participants, study site personnel, study sponsor, outcome assessors (raters), and statisticians were blinded to treatment assignment. Results: A total of 104 participants (mean [SD] age, 41.1 [11.3] years; 52 [50%] women) were randomized (51 to the psilocybin group and 53 to the niacin group). Psilocybin treatment was associated with significantly reduced MADRS scores compared with niacin from baseline to day 43 (mean difference,-12.3 [95% CI, -17.5 to -7.2]; P <.001) and from baseline to day 8 (mean difference, -12.0 [95% CI, -16.6 to -7.4]; P < .001). Psilocybin treatment was also associated with significantly reduced Sheehan Disability Scale scores compared with niacin (mean difference, -2.31 [95% CI, 3.50-1.11]; P < .001) from baseline to day 43. More participants receiving psilocybin had sustained response (but not remission) than those receiving niacin. There were no serious treatment-emergent AEs; however, psilocybin treatment was associated with a higher rate of overall AEs and a higher rate of severe AEs. Conclusions and relevance: Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and functional disability, without serious adverse events. These findings add to increasing evidence that psilocybin-when administered with psychological support-may hold promise as a novel intervention for MDD. Trial registration: Identifier: NCT03866174.
... Despite these encouraging findings, existing PAP studies have failed to recruit ethnoracially diverse samples (George et al. 2020;Michaels et al. 2018). Possible barriers include systemic and institutional racism in medical systems and the War on Drugs (George et al. 2020); the influence of collectivistic culture on receptivity to participating in drugrelated research (Du et al. 2014;Johnson 2007); stigma against the use of scheduled substances, mental illness, and help-seeking (Duff, Puri, and Chow 2011;Gary 2005;McCabe et al. 2007); and culturally insensitive recruitment methods (Williams, Reed, and Aggarwal 2020). Low Black, Indigenous, and People of Color (BIPOC) inclusion in PAP trials poses a limit to generalizability and needs to be addressed as PAP research programs advance toward federal-level approval (e.g., Burge 2017). ...
... This implies a potentially underutilized recruitment strategy (i.e., word of mouth) in terms of increasing BIPOC representation in PAP trials. It is possible that once psychoeducation around PAP is provided to gatekeepers (e.g., church or grassroots leaders) of BIPOC communities (Williams, Reed, and Aggarwal 2020), information about existing PAP trials in their area can be internally disseminated. ...
Psychedelic-assisted psychotherapy (PAP) is gaining renewed interest as a treatment for various mental disorders. However, there has been limited Black, Indigenous, and People of Color (BIPOC) representation in PAP clinical trials, signaling the need for culturally consonant communication about the efficacy and safety of PAP. We randomly assigned 321 BIPOC and 301 non-Hispanic White participants to four different modes of psychoeducation (didactic, visual, narrative, hope-based) and tested effects on likelihood of seeking and referring others to PAP using ANCOVAs. The influences of different psychoeducation components on these likelihoods were also tested using hierarchical regression modeling. Regardless of psychoeducation mode, BIPOC participants were more likely to seek PAP than non-Hispanic White participants after psychoeducation. Further, information on physical safety and success rate of PAP uniquely predicted BIPOC participants' likelihood of seeking and referring others to PAP after psychoeducation. Our findings suggest that once provided psychoeducation, BIPOC participants are receptive to seeking or referring others to PAP. BIPOC participants also appear to prioritize physical safety and rate of success of PAP in these decisions. Stigma against PAP is likely not the primary barrier to recruitment of BIPOC individuals into PAP trials. Instead, researchers should conduct more psychoeducational outreach to diversify future trials.
... Our findings, with Black American racial identification being a predictor of more positive baseline views, and significant interactions for both interest and views such that Black participants reporting more depression symptoms reporting greater levels of interest and positive views of PAT, spotlight the need to look beyond individual attributions and focus more attention on the ways treatment structures and systems limit access to mental health treatments among minoritized populations. Despite historical experiences of unethical treatment in research and ongoing contemporary factors leading to barriers to treatment engagement, Black Americans demonstrate significant interest engaging in psychedelic clinical research and are particularly responsive to PAT psychoeducation, suggesting the need for more active outreach and efforts to minimize barriers to accessing PAT trials for minoritized groups [39]. In righting the wrong of historical exclusion of Black communities who might otherwise benefit from innovative clinical trials, the onus of change ostensibly falls on the shoulders of institutions that host these studies. ...
The present study investigated differences in perceptions of psychedelic-assisted therapy between Black and White Americans, as well as factors that may influence these perceptions. A final sample of 294 adults (42% female, 44% Black/African American or Mixed Race (of Black/African ancestry), 56% White American; Mage = 36.3 years) completed an online survey which assessed baseline knowledge and views of psychedelic-assisted therapy. Participants were then provided brief psychoeducation related to MDMA and psilocybin-assisted therapy. After psychoeducation, participants were queried on their perceptions of psychedelic-assisted therapy and factors potentially influencing these perceptions, including trauma history, current depressive and PTSD symptoms, racism-related stress, and perceived barriers to psychological treatments. Psychoeducation had a positive impact on both level of interest and positivity of views of psychedelic-assisted therapy across groups. Black American participants reported more positive views of psychedelic-assisted therapy than White participants following psychoeducation. Greater depression and PTSD symptom severity was associated with greater baseline interest in Black and White Americans and there was significant interactions in predicting baseline view and interest, such that Black participants who reported greater depression symptom severity were more interested and had more positive views of PAT. Despite historical exclusion from psychedelic clinical trials and experiences of unethical treatment in research, Black Americans demonstrate more positive views of psychedelic therapy and Black Americans more in need of novel mental health care demonstrate more interest and more positive views. Our findings demonstrate that the onus for diversification of psychedelic research samples is on research groups. These findings also provide an impetus for the psychedelic research community to rebuild trust in psychedelic research among Black Americans, conduct outreach, and provide culturally attuned psychedelic-assisted interventions that are accessible to Black Americans.
... Also still unknown are the broader implementations of psychedelic use for mental health treatment that would prevent misuse and abuse in clinical practice, including appropriate ethical guidelines, adequate provider training programs, regulatory structures for oversight and guidance, as well as the culturally and trauma-informed inclusion of people of colour in this powerful treatment modality Bender & Hellerstein, 2022;Phelps, 2017;Williams et al., 2019). ...
Full-text available
In recent years a renewed scientific, public and commercial interest in psychedelic medicines can be observed across the globe. As research findings have been generally promising, there is hope for new treatment possibilities for a number of difficult-to-treat mental health concerns. While honouring positive developments and therapeutic promise in relation to the medical use of psychedelics, this paper aims to shine a light on some underlying psycho-cultural shadow dynamics in the unfolding psychedelic renaissance. This paper explores whether and how the multi-layered collective fascination with psychedelics may yet be another symptom pointing towards a deeper psychological and spiritual malaise in the modern Western psyche as diagnosed by C. G. Jung. The question is posed whether the West's feverish pursuit of psychedelic medicines-from individual consumption to entheogenic tourism, from capitalist commodification of medicines and treatments to the increasing number of ethical scandals and abuse through clinicians and self-proclaimed shamans-is related to a Western cultural complex. As part of the discussion, the archetypal image of the Hungry Ghost, known across Asian cultural and religious traditions, is explored to better understand the aforementioned shadow phenomena and point towards mitigating possibilities.
... Phase 2 refers to co-design with the wider community through implementation and continued feedback. this treatment can help and how (Murphy et al., 2022) when it might be unhelpful or harmful and how to work in culturally sensitive ways and with marginalized groups (Anderson et al., 2019;Williams et al., 2020;Williams M. T. et al., 2021). ...
Full-text available
The field of psychedelic assisted therapy (PAT) is growing at an unprecedented pace. The immense pressures this places on those working in this burgeoning field have already begun to raise important questions about risk and responsibility. It is imperative that the development of an ethical and equitable infrastructure for psychedelic care is prioritized to support this rapid expansion of PAT in research and clinical settings. Here we present Access, Reciprocity and Conduct (ARC); a framework for a culturally informed ethical infrastructure for ARC in psychedelic therapies. These three parallel yet interdependent pillars of ARC provide the bedrock for a sustainable psychedelic infrastructure which prioritized equal access to PAT for those in need of mental health treatment (Access), promotes the safety of those delivering and receiving PAT in clinical contexts (Conduct), and respects the traditional and spiritual uses of psychedelic medicines which often precede their clinical use (Reciprocity). In the development of ARC, we are taking a novel dual-phase co-design approach. The first phase involves co-development of an ethics statement for each arm with stakeholders from research, industry, therapy, community, and indigenous settings. A second phase will further disseminate the statements for collaborative review to a wider audience from these different stakeholder communities within the psychedelic therapy field to invite feedback and further refinement. By presenting ARC at this early stage, we hope to draw upon the collective wisdom of the wider psychedelic community and inspire the open dialogue and collaboration upon which the process of co-design depends. We aim to offer a framework through which psychedelic researchers, therapists and other stakeholders, may begin tackling the complex ethical questions arising within their own organizations and individual practice of PAT.
... The lack of diversity among trained facilitators represents a systemic issue for the field of psychedelic therapy, and likely contributes to the racial homogeneity of study participants typically found in psychedelic clinical trials. 48,49 The proportion of therapists with a doctoral degree tended to be higher than that typically found in nonpsychedelic psychotherapy; however, this likely reflects rules of the sponsor for the study (i.e., there must be a licensed PhD/PsyD or MD in each therapy pair). It is important to note that four participants did not have formal psychotherapy graduate training but had pursued other relevant training experiences. ...
Full-text available
Background: An emerging controversy in psychedelic therapy regards the appropriateness or necessity of psychedelic therapists having personal experience using psychedelics themselves. Although there are a number of potential advantages and disadvantages to personal use among psychedelic therapists, no studies to date have measured their use or other aspects of their training. Materials and Methods: First, we broadly review the literature on experiential learning in psychotherapy and psychiatry as well as the history of personal use of psychedelics by professionals. We then report on the results of a survey that was sent to all 145 therapists associated with Usona Institute's Phase II clinical trial of psilocybin for major depressive disorder. Thirty-two of these individuals (22% response rate) participated in the survey. Results: We found that experiential learning is common in psychotherapy but not in psychiatry, meaning psychedelic therapy straddles two different traditions. In our survey, the majority of psychedelic therapists identified as white, female, and having doctoral degrees. Most of the sample had personal experience with at least one serotonergic psychedelic (28/32; 88%), with psilocybin being most common (26/32; 81%; median number of uses = 2–10; median last use 6–12 months before survey). Participants had myriad intentions for using psychedelics (e.g., personal development, spiritual growth, fun, curiosity). All respondents endorsed favorable views regarding the efficacy of psilocybin therapy. Conclusion: Personal experience with psychedelics was notably common in this sample of psychedelic therapists, but the study was limited by a low response rate and a lack of diversity among participants. Future research is needed to address these limitations as well as to identify whether personal experience with psychedelics contributes to therapists' competency or introduces bias to the field. Nonetheless, these findings are the first to delineate the personal use of psychedelics among professionals and can inform a pressing debate for the field.
Full-text available
A rapid review synthesizing published research on the possible therapeutic applications of psychedelics.
Although there is a growing support for the use of psychedelics to improve the health of marginalized groups, there are some critical gaps. First, no empirical studies have examined the effects of psychedelics on Black Americans. Second, there is little research on population effects of psychedelics. Third, little research has tested how cultural set and setting may affect the relationship between psychedelics and health. Specifically, how could economic inequality or the criminal justice system jeopardize the relationship between psychedelics and health for Black people. This study tests race and gender differences in multiple aspects of lifetime classic psychedelic use, specifically drug use, arrest history, economic inequality, and psychological distress. This project uses pooled data of Black and White respondents from the National Survey of Drug Use and Health (2008–2019) ( N = 490,586). The analysis includes a series of logistic and ordinary least square regression models conducted in Stata 17. Results demonstrate that Black people are policed more even though they use less drugs than Whites. Higher class White men are more likely to use psychedelics, while class does not predict use among Black people. Finally, for White men and women, the positive association of psychedelics are enhanced by class, while the negative effect of arrest history on health are buffered by psychedelics. However, Black people do not gain health benefits from psychedelics regardless of class or arrest history. Results suggest that systemic inequality deters use and eliminates all health benefits of psychedelics for Black people.
Full-text available
The road to the current psychedelic renaissance in research on ±3,4-methylenedioxymethamphetamine (MDMA) – the active ingredient of the drug Ecstasy – for addressing treatment-resistant posttraumatic stress disorder (PTSD) has been fraught with political and academic bias, as well as cultural stigma among underserved populations, all of which serve as barriers to minority inclusion and participation. In this open letter to ethnic/racial and sexual/gender minorities, the author details intersectional insights from his own experience being administered MDMA legally as part of a therapist training trial for MDMA-assisted psychotherapy, in hopes of radically destigmatizing this treatment approach for marginalized populations. Themes covered include: set and setting; cultural pride; LGBTQIA+ pride; acceptance of intersectionality; as well as patience, perspective, and strength in retrospection. This letter concludes by tasking current investigators of MDMA-assisted psychotherapy to emphasize issues of intersecting identities (e.g., in terms of race, ethnicity, sexual orientation, gender identity) in their research agenda, attempt to improve minority participation in a culturally attuned manner, as well as increase minority stakeholdership in this field.
Full-text available
Published in: Directions in Psychiatry, 38, 179-196. LEARNING OBJECTIVES: On completing this lesson, the clinician will be able to (1) recognize various factors that contribute to an increased risk for posttraumatic stress disorder (PTSD) in people of color; (2) identify under-recognized race-based traumatic experiences; and (3) indicate appropriate applications of assessment tools and treatments for race-based trauma and PTSD in people of color. LESSON ABSTRACT: Ethnic and racially motivated traumatic events can cause PTSD in people of color. Unfortunately, this type of trauma is often not identified during clinical assessments. PTSD can persist without appropriate treatment, and failure to detect it may only prolong the distress further and increase the risk of developing and maintaining PTSD. This lesson presents information about up-to-date methods of detecting racial trauma, validated self-report and clinician-administered PTSD assessment tools that are appropriate to use with persons of color, and guidelines for selecting the most appropriate treatment for patients race trauma-related PTSD. Additionally, common causes of racial trauma are identified and case examples are provided to help clinicians conceptualize racial trauma and support their ability to detect racial trauma-related PTSD in patients of color. COMPETENCY AREAS: This lesson supports patient care and clinician performance in practice by providing current information and appropriate tools to identify and assess racial trauma-induced PTSD accurately in patients of color. It also summarizes treatments considered appropriate based on current research and evidence‐based practices and identifies feasible methods of evaluation and support. KEY WORDS: posttraumatic stress disorder; ethnic differences; symptom assessment; psychotherapy; racism
Full-text available
Background: Despite renewed interest in studying the safety and efficacy of psychedelic-assisted psychotherapy for the treatment of psychological disorders, the enrollment of racially diverse participants and the unique presentation of psychopathology in this population has not been a focus of this potentially ground-breaking area of research. In 1993, the United States National Institutes of Health issued a mandate that funded research must include participants of color and proposals must include methods for achieving diverse samples. Methods: A methodological search of psychedelic studies from 1993 to 2017 was conducted to evaluate ethnoracial differences in inclusion and effective methods of recruiting peopple of color. Results: Of the 18 studies that met full criteria (n = 282 participants), 82.3% of the participants were non-Hispanic White, 2.5% were African-American, 2.1% were of Latino origin, 1.8% were of Asian origin, 4.6% were of indigenous origin, 4.6% were of mixed race, 1.8% identified their race as "other," and the ethnicity of 8.2% of participants was unknown. There were no significant differences in recruitment methodologies between those studies that had higher (> 20%) rates of inclusion. Conclusions: As minorities are greatly underrepresented in psychedelic medicine studies, reported treatment outcomes may not generalize to all ethnic and cultural groups. Inclusion of minorities in futures studies and improved recruitment strategies are necessary to better understand the efficacy of psychedelic-assisted psychotherapy in people of color and provide all with equal opportunities for involvement in this potentially promising treatment paradigm.
Full-text available
Background: Post-traumatic stress disorder (PTSD) is prevalent in military personnel and first responders, many of whom do not respond to currently available treatments. This study aimed to assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treating chronic PTSD in this population. Methods: We did a randomised, double-blind, dose-response, phase 2 trial at an outpatient psychiatric clinic in the USA. We included service personnel who were 18 years or older, with chronic PTSD duration of 6 months or more, and who had a Clinician-Administered PTSD Scale (CAPS-IV) total score of 50 or greater. Using a web-based randomisation system, we randomly assigned participants (1:1:2) to three different dose groups of MDMA plus psychotherapy: 30 mg (active control), 75 mg, or 125 mg. We masked investigators, independent outcome raters, and participants until after the primary endpoint. MDMA was administered orally in two 8-h sessions with concomitant manualised psychotherapy. The primary outcome was mean change in CAPS-IV total score from baseline to 1 month after the second experimental session. Participants in the 30 mg and 75 mg groups subsequently underwent three 100-125 mg MDMA-assisted psychotherapy sessions in an open-label crossover, and all participants were assessed 12 months after the last MDMA session. Safety was monitored through adverse events, spontaneously reported expected reactions, vital signs, and suicidal ideation and behaviour. This study is registered with, number NCT01211405. Findings: Between Nov 10, 2010, and Jan 29, 2015, 26 veterans and first responders met eligibility criteria and were randomly assigned to receive 30 mg (n=7), 75 mg (n=7), or 125 mg (n=12) of MDMA plus psychotherapy. At the primary endpoint, the 75 mg and 125 mg groups had significantly greater decreases in PTSD symptom severity (mean change CAPS-IV total scores of -58·3 [SD 9·8] and -44·3 [28·7]; p=0·001) than the 30 mg group (-11·4 [12·7]). Compared with the 30 mg group, Cohen's d effect sizes were large: 2·8 (95% CI 1·19-4·39) for the 75 mg group and 1·1 (0·04-2·08) for the 125 mg group. In the open-label crossover with full-dose MDMA (100-125 mg), PTSD symptom severity significantly decreased in the group that had previously received 30 mg (p=0·01), whereas no further significant decreases were observed in the group that previously achieved a large response after 75 mg doses in the blinded segment (p=0·81). PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (mean CAPS-IV total score of 38·8 [SD 28·1] vs 87·1 [16·1]; p<0·0001). 85 adverse events were reported by 20 participants. Of these adverse events, four (5%) were serious: three were deemed unrelated and one possibly related to study drug treatment. Interpretation: Active doses (75 mg and 125 mg) of MDMA with adjunctive psychotherapy in a controlled setting were effective and well tolerated in reducing PTSD symptoms in veterans and first responders. Funding: Multidisciplinary Association for Psychedelic Studies.
Full-text available
Rationale: Recent studies have supported the safety and efficacy of psychedelic therapy for mood disorders and addiction. Music is considered an important component in the treatment model, but little empirical research has been done to examine the magnitude and nature of its therapeutic role. Objectives: The present study assessed the influence of music on the acute experience and clinical outcomes of psychedelic therapy. Methods: Semi-structured interviews inquired about the different ways in which music influenced the experience of 19 patients undergoing psychedelic therapy with psilocybin for treatment-resistant depression. Interpretative phenomenological analysis was applied to the interview data to identify salient themes. In addition, ratings were given for each patient for the extent to which they expressed "liking," "resonance" (the music being experienced as "harmonious" with the emotional state of the listener), and "openness" (acceptance of the music-evoked experience). Results: Analyses of the interviews revealed that the music had both "welcome" and "unwelcome" influences on patients' subjective experiences. Welcome influences included the evocation of personally meaningful and therapeutically useful emotion and mental imagery, a sense of guidance, openness, and the promotion of calm and a sense of safety. Conversely, unwelcome influences included the evocation of unpleasant emotion and imagery, a sense of being misguided and resistance. Correlation analyses showed that patients' experience of the music was associated with the occurrence of "mystical experiences" and "insightfulness." Crucially, the nature of the music experience was significantly predictive of reductions in depression 1 week after psilocybin, whereas general drug intensity was not. Conclusions: This study indicates that music plays a central therapeutic function in psychedelic therapy.
Full-text available
Theory and research in cultural psychology highlight the need to examine racism not only “in the head” but also “in the world.” Racism is often defined as individual prejudice, but racism is also systemic, existing in the advantages and disadvantages imprinted in cultural artifacts, ideological discourse, and institutional realities that work together with individual biases. In this review, we highlight examples of historically derived ideas and cultural patterns that maintain present-day racial inequalities. We discuss three key insights on the psychology of racism derived from utilizing a cultural-psychology framework. First, one can find racism embedded in our everyday worlds. Second, through our preferences and selections, we maintain racialized contexts in everyday action. Third, we inhabit cultural worlds that, in turn, promote racialized ways of seeing, being in, and acting in the world. This perspective directs attempts at intervention away from individual tendencies and instead focuses on changing the structures of mind in context that reflect and reproduce racial domination.
Full-text available
Published in Journal of Racial and Ethnic Health Disparities, 5, 919-927. Prior research has demonstrated a clear relationship between experiences of racial microaggressions and various indicators of psychological unwellness. One concern with these findings is that the role of negative affectivity, considered a marker of neuroticism, has not been considered. Negative affectivity has previously been correlated to experiences of racial discrimination and psychological unwellness and has been suggested as a cause of the observed relationship between microaggressions and psychopathology. We examined the relationships between self-reported frequency of experiences of microaggressions and several mental health outcomes (i.e., anxiety [Beck Anxiety Inventory], stress [General Ethnic and Discrimination Scale], and trauma symptoms [Trauma Symptoms of Discrimination Scale]) in 177 African American and European American college students, controlling for negative affectivity (the Positive and Negative Affect Schedule) and gender. Results indicated that African Americans experience more racial discrimination than European Americans. Negative affectivity in African Americans appears to be significantly related to some but not all perceptions of the experience of discrimination. A strong relationship between racial mistreatment and symptoms of psychopathology was evident, even after controlling for negative affectivity. In summary, African Americans experience clinically measurable anxiety, stress, and trauma symptoms as a result of racial mistreatment, which cannot be wholly explained by individual differences in negative affectivity. Future work should examine additional factors in these relationships, and targeted interventions should be developed to help those suffering as a result of racial mistreatment and to reduce microaggressions.
Journal: Practice Innovations. Many ethnic minority groups experience higher rates of posttraumatic stress disorder (PTSD) compared to their European American counterparts. One explanation for this is the differential experience of racism, which can itself be traumatic. This article aims to provide a theoretical basis for the traumatizing nature of various forms of racism within the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders ’ framework for PTSD. PTSD caused by racism, or racial trauma, is likely to be underrecognized due to a lack of awareness among clinicians, discomfort surrounding conversations about race in therapeutic settings, and a lack of validated measures for its assessment. We review the literature and existing measures for the assessment of racial trauma and introduce the UConn Racial/Ethnic Stress & Trauma Survey (UnRESTS), a clinician-administered interview. The UnRESTS is useful to clinicians as an aid to uncovering racial trauma, developing a culturally informed case conceptualization, and including experiences of racism in the diagnosis of PTSD when warranted. Three case examples that describe the impact of racial stress and trauma and the role of the UnRESTS in understanding the experiences of those impacted by racism are included.
Therapists and mental health professionals strive to provide competent treatment to increasingly diverse populations, but can struggle to effectively engage with clients from different cultural backgrounds. Cultural humility is an approach and process that can help facilitate strong working alliances between therapists and diverse clients, leading to better therapy outcomes. In this article, we first consolidate definitions of cultural humility and work to better operationalize the construct. Next, we provide a brief review of empirical studies examining the role of cultural humility in therapy. Then, we offer a 4-part framework for applying cultural humility in therapy by (a) engaging in critical self-examination and self-awareness, (b) building the therapeutic alliance, (c) repairing cultural ruptures, and (d) navigating value differences. Finally, we illustrate what cultural humility looks like in the therapy room with two case studies.
The research literature on MDMA (ecstasy/molly) use has largely relied on samples of ravers/club-goers, gay men, and international populations (e.g., United Kingdom, Australia). As a result, very little is known about MDMA use among African Americans. This study aimed to address this gap by adding to the limited amount of research with this population. The goal of this study was to identify and characterize the perceived risks that African Americans associate with using MDMA. Surveys (n = 100) and in-depth interviews (n = 15) were conducted with African American young adults in Southwest Florida between August 2014 and November 2015. Almost the entire sample (91%) associated risks with their MDMA use. The most prevalent types of perceived risks associated with MDMA use were physical harm (e.g., dehydration, fatal overdose, and cardiac damage). Qualitative interview data are also presented to better contextualize these perceived risks. These data provide insight into the risks most salient on the minds of African Americans, and can be used to begin developing and tailoring interventions that target MDMA use among this population. While more research is needed on this topic, these results represent a step forward in our understanding of MDMA use among African Americans.