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Integrating Contextual Behavioral Science with Research on Psychedelic Assisted Therapy: Introduction to the Special Section

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Jason B Luoma
Jason B Luoma
Alan Kooi Davis at The Ohio State University
Alan Kooi Davis
Rosalind Watts
Rosalind Watts
Rosalind Watts
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Lance McCracken at Uppsala University
Lance McCracken
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Abstract

Scientific research on the therapeutic use of psychedelics has rapidly expanded over the past decade and, over the next decade, they may be approved for clinical use. Psychedelics have been used for centuries in ritual, community, and spiritual contexts and yet the potential for a scientific approach to these drugs has possibly never been greater than it is now. Modern well controlled trials show preliminary efficacy in relation to a range of different psychological problems. In this introduction we outline the aims of this special issue, present the case for integrating psychedelics and contextual behavioral science, and provide an overview of the papers in the issue.
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Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
Integrating Contextual Behavioral Science with Research on Psychedelic Assisted Therapy:
Introduction to the Special Section
Jason B. Luoma, Ph.D.
Portland Psychotherapy Clinic, Research, & Training Center
Alan K. Davis, Ph.D.
College of Social Work, The Ohio State University
Center for Psychedelic and Consciousness Research, Department of Psychiatry, Johns Hopkins
School of Medicine
Rosalind Watts, DClinPsy
Imperial College London Psychedelic Research Group
Lance M. McCracken, Ph.D.
Division of Clinical Psychology, Psychology Department, Uppsala University
Author Note
Address correspondence to: Jason Luoma, Ph.D., Portland Psychotherapy, 3700 N Williams,
Portland, OR 97227, USA. Contact: jbluoma@portlandpsychotherapyclinic.com
Dr. Davis was supported by funding for the Center for Psychedelic and Consciousness Research
provided by Steven and Alexandra Cohen Foundation, Tim Ferriss, Matt Mullenweg, Craig
Nerenberg, and Blake Mycoskie. The funding sources had no role in the design/execution of this
study or the interpretation or communication of findings.
This is the peer reviewed version of the following article and therefore it might have some
differences from the final published version, which is: Luoma, J.B., Davis, A. K., Watts, R., &
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
McCracken, L. (2020) Integrating contextual behavioral science with research on psychedelic
assisted therapy: introduction to the special section. Journal of Contextual Behavioral Science,
15, 207-209. https://doi.org/10.1016/j.jcbs.2020.01.004
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
Abstract
Scientific research on the therapeutic use of psychedelics has rapidly expanded over the past
decade and, over the next decade, they may be approved for clinical use. Psychedelics have been
used for centuries in ritual, community, and spiritual contexts and yet the potential for a
scientific approach to these drugs has possibly never been greater than it is now. Modern well
controlled trials show preliminary efficacy in relation to a range of different psychological
problems. In this introduction we outline the aims of this special issue, present the case for
integrating psychedelics and contextual behavioral science, and provide an overview of the
papers in the issue.
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
Integrating Contextual Behavioral Science with Research on Psychedelic Assisted Therapy:
Introduction to the Special Section
For over a decade, psychedelic research has been rapidly expanding. The bulk of clinical
research has focused on psilocybin, with more than thirty approved clinical studies investigating
its therapeutic potential (Clinicaltrials.gov, 2019. Psilocybin-assisted therapy shows promise as
an effective treatment for depression (Carhart-Harris et al., 2018), addiction (Johnson, Garcia-
Romeu, & Griffiths, 2017), and existential anxiety and depression related to life-threatening
illness (Grob et al., 2011; Griffiths et al., 2016; Ross et al., 2017), among other conditions. Other
classical psychedelics, such as lysergic acid diethylamide (LSD) and dimethyltryptamine (DMT)
are also under clinical investigation, though generally receiving much less research attention. In
addition, the non-classical psychedelic, 3,4-Methylenedioxymethamphetamine (MDMA), is
currently being studied in large scale Phase 3 trials with the potential for becoming legally
available in the United States for prescription use for post-traumatic stress disorder (Mithoefer et
al., 2019) as early as 2021.
What are the Classical Psychedelics?
The classical psychedelics include psilocybin, DMT, LSD and mescaline. Psilocybin was
introduced to the west after a sample of psilocybe mexicana mushrooms used by the curandera
Maria Sabina, were sent from Mexico to Switzerland to be analyzed by the chemist Albert
Hoffman, who later developed techniques for synthesizing the psychoactive chemical (Moriarty,
Alagna, & Lake, 1984). DMT is often ingested as part of the plant brew, ayahuasca, in
ceremonial contexts, as it has been for centuries (Labate, Cavnar, & Gearin, 2016). Ayahuasca
research has taken place in retreat settings in South America and is increasingly being explored
in clinical research settings (e.g., Sanchez et al., 2016; Soler et al., 2018), although less
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
frequently than psilocybin. Mescaline is usually ingested in its plant form via the cacti San Pedro
or Peyote and also has a strong tradition of ceremonial use in Mexico and South America.
Mescaline was synthesized in the late 1800s and was written about by Aldous Huxley (Pollan,
2019), but is yet to find its place in modern scientific research. The psychedelic effects of the
synthesized compound LSD were first discovered in 1943 and LSD is perhaps the most widely
known psychedelic perhaps due to its strong associations with the 1960s counterculture
movement. In 1970, despite early evidence that psychedelics had potential therapeutic benefit
and evidence that they were largely non-addictive (e.g., Johansen & Krebs, 2015), the United
States Drug Enforcement Agency classified them as Schedule I substances (having no accepted
medical use and high potential for dependence) in 1970 (Johnson, Griffiths, Hendricks, &
Henningfield, 2018). Clinicians and researchers were increasingly banned from prescribing and
studying them and psychedelic research essentially halted over the next few years. However,
research on the use of psychedelics to understand more about consciousness and mental health
has re-emerged over the past 20 years, with LSD being investigated as a treatment for anxiety
association with life threatening illness Switzerland (Gasser, Kirchner, & Passie, 2015), and
psilocybin (e.g., Griffiths et al., 2016) and MDMA (Bahji, Forsyth, Groll, & Hawken, 2020)
being investigated internationally for a variety of mental health difficulties.
Primary Aims of This Special Issue
This special issue has five aims. First, to summarize the current state of the literature
relating to psychedelic assisted therapy for new audiences. Second, to introduce how Acceptance
and Commitment Therapy (ACT) and Contextual Behavioral Science (CBS) could be used to
inform psychedelic-assisted therapy. Third, to present new and innovative contributions from
CBS that can inform future research on psychedelics. Fourth, to explore how psychedelic science
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
may advance the goals of CBS. Finally, we aim to correct misinformation about psychedelics
and inspire the interest of therapists and researchers in the potential of these tools to catalyze
greater acceptance and help people connect with self, others, and values.
Why Integrate Contextual Behavioral Science and Psychedelic Research?
One of the unique aspects of psychedelics is that their effects depend profoundly upon the
context in which they are used (Carhart-Harris, Roseman, Haijen, Erritzoe, Watts, Branchi, &
Kaelen, 2018) This is in contrast to most pharmacological agents, such as antidepressants or
anxiolytics (Hartogsohn, 2017) where setting effects are largely ignored. This need to create a
supportive “set and setting” is widely accepted among researchers of psychedelic assisted
therapy and is part of why researchers are beginning to test and refine the psychotherapy
component of psychedelic assisted therapy. CBS emphasizes the centrality of context for
understanding or changing behavior (Hayes, Barnes-Holmes, & Wilson, 2012) and, as such, is
uniquely suited to understanding psychedelic experience and its potential therapeutic benefits.
CBS seems a fitting framework for informing how to focus, strengthen, and maintain the often
profound acute effects these compounds (when used in a supportive context). In recognition of
this fit, at least two current clinical trials of psychedelic-assisted therapy are using principles
derived from ACT and CBS to guide implementation.
CBS is well positioned to address several current needs in psychedelic science. Most
centrally, the scientific study of psychedelic assisted therapy has largely neglected study of the
psychotherapeutic component of treatment - no existing studies having systematically
manipulated this component. CBS can contribute to the development of the psychotherapeutic
component of psychedelic-assisted therapy in a number of ways. First, CBS can provide
guidance on how to maximize outcomes through the application of a robust body of research on
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
processes of change underlying mental health conditions. The psychological theories emerging
from CBS such as psychological flexibility (Hayes, Strosahl, & Wilson, 2012) and relational
frame theory (Hayes, Barnes-Holmes, & Roche, 2001) fit with the phenomenological experience
of psychedelics, existing information on processes of change, and neurobiological accounts. In
sum, CBS can guide investigation into the contextual factors that affect not only how these
compounds work in the acute phase, but also how acute effects can better translate into lasting
change.
CBS is also uniquely positioned to address some aspects of the psychedelic experience
that are not well addressed in other evidence-based approaches to behavior change. First, CBS
has a long tradition of addressing the spiritual, mystical, and transcendent aspects of human
experience that are often made apparent during high dose psychedelic experiences (e.g., Hayes,
1984). Second, CBS also has psychological models that can address the important role of
alterations in language and cognition that are part of psychedelic experience and, in particular,
the phenomenon of ineffability (Luoma et al., in press). Third, CBS concepts emerging from
relational frame theory may be able to address alterations in the sense of self, such as ego
dissolution, encounters with inner teachers or mystical beings, or experiences of transcendent
love toward self and others that are commonly experienced in psychedelic-assisted therapy
(Luoma et al., in press; Hayes, Law, Malady, Zhu, & Bai, in press).
Overview of the Special Section
The seven papers in this special section cover a wide range of topics as part of this first
attempt to link CBS and psychedelic science. The first paper provides an overview of the history
of psychedelic science, attempts to correct common misconceptions about psychedelics, and
explores how CBS frameworks may be applied to understanding psychedelics and their use in
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
treatment (Luoma, Subucedo, Eriksson, Gates, & Pilecki, in press). The next two papers describe
how therapeutic models based on CBS and ACT are being used to inform psychedelic assisted
therapy (Sloshower, Guss, Krause, Wallace, Williams, Reed, & Skinta, in press; Watts &
Luoma, in press). This is followed by two papers that include the first empirical evidence of
associations between changes in psychological flexibility and psychedelic experiences (Close,
Haijen, Watts, Roseman, Carhart-Harris, in press; Davis, Barrett, & Griffiths, in press), thus
providing empirical support for how CBS-based models of psychological change are relevant to
psychedelic assisted therapy. A sixth paper focuses on how a CBS perspective can elucidate the
changes in sense of self frequently experienced as part of psychedelics (Hayes, Law, Malady,
Zhu, Bai, in press). The final paper in the special section explores how psychedelics might be
useful in the treatment of borderline personality disorder and discusses potential processes of
change linked to CBS such as mindfulness and self-compassion (Zeifman & Wagner, in press).
Our hope is this special section will encourage further research into combination
therapies that are both pharmacological and psychological, particularly including psychedelics.
This work will need to include further study of processes of therapeutic change that operate
regardless of the type of treatment applied. Psychedelics are interesting and potentially powerful
agents for reducing human suffering and for realizing human potential to achieve and flourish.
With the possible stigma associated with these chemicals, the potential for hype, or to see them
as either “cure all” or nonsense, what better way to address the questions around psychedelics,
broadly, precisely, and deeply, than with contextual behavioral science?
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
References
Bahji, A., Forsyth, A., Groll, D., & Hawken, E. R. (2020). Efficacy of 3, 4-
methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic
stress disorder: A systematic review and meta-analysis. Progress in Neuro-
Psychopharmacology and Biological Psychiatry, 96, 109735.
Carhart-Harris, R. L., Roseman, L., Haijen, E., Erritzoe, D., Watts, R., Branchi, I., & Kaelen, M.
(2018). Psychedelics and the essential importance of context. Journal of
Psychopharmacology, 32(7), 725-731.
Carhart-Harris R.L., Bolstridge M., Day C.M.J., Rucker J., Watts R., Erritzoe D.E., Kaelen, M.,
Giribaldi, B., Bloomfield, M., Piling, S., Rickard, J.A., Forbes, B., Feilding, A., Taylor,
D., Curran, H.V., & Nutt, D.J. (2018). Psilocybin with psychological support for
treatment-resistant depression: six-month follow-up. Psychopharmacology, 235(2), 399–
408.
ClinicalTrials.gov (2010). Retrieved November 20, 2019 from: www.clinicaltrials.gov.
Close, J. B., Haijen, E. C., Watts, R., Roseman, L, & Carhart-Harris, R. L. (in press).
Psychedelics promote psychological flexibility – Results of a prospective websurvey
using the Acceptance in Action Questionnaire II. Journal of Contextual Behavioral
Science.
Davis, A.K., Barrett, F., & Griffiths, R. R. (in press). Psychological flexibility mediates the
relations between acute psychedelic effects and subjective changes in depression and
anxiety. Journal of Contextual Behavioral Science.
Gasser, P., Kirchner, K., & Passie, T. (2015). LSD-assisted psychotherapy for anxiety associated
with a life-threatening disease: a qualitative study of acute and sustained subjective
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
effects. Journal of Psychopharmacology, 29(1), 57-68.
Griffiths R.R., Johnson MW., Carducci M.A., Umbricht A., Richards W.A., Richards B.D.,
Cosimano, M.P., & Klinedinst, A. (2016). Psilocybin produces substantial and sustained
decreases in depression and anxiety in patients with life-threatening cancer: A
randomized double-blind trial. Journal of Psychopharmacology, 30(12), 1181-1197.
Grob C.S., Danforth A.L., Chopra G.S., Hagerty M., McKay C.R., Halberstadt A.L., & Greer,
G.R. (2011). Pilot study of psilocybin treatment for anxiety in patients with advanced-
stage cancer. Archives of General Psychiatry, 68(1), 71-78.
Hartogsohn, I. (2017). Constructing drug effects: A history of set and setting. Drug Science,
Policy and Law, 3, 205032451668332.
Hayes, S.C. (1984). Making sense of spirituality. Behaviourism, 12(2), 99-110.
Hayes, S.C., Barnes-Holmes, D., & Roche, B. (2001). Relational Frame Theory: A Post-
Skinnerian Account of Human Language and Cognition. New York, NY: Springer US.
Hayes, S. C., Barnes-Holmes, D., & Wilson, K. G. (2012). Contextual behavioral science:
Creating a science more adequate to the challenge of the human condition. Journal of
Contextual Behavioral Science, 1(1–2), 1–16.
Hayes, S. C. Law, S., Malady, M. Zhu, Z., & Bai, X. (in press). The Centrality of Sense of Self
in Psychological Flexibility Processes: What the Neurobiological and Psychological
Correlates of Psychedelics Suggest. Journal of Contextual Behavioral Science.
Hayes, S.C., Strosahl, K.D., & Wilson K.G. (1999). Acceptance and Commitment Therapy: The
process and practice of mindful change. New York, NY: Guilford Press.
Johansen, P. Ø., & Krebs, T. S. (2015). Psychedelics not linked to mental health problems or
suicidal behavior: A population study. Journal of Psychopharmacology, 29(3), 270-279.
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
Johnson M.W., Garcia-Romeu A., & Griffiths R.R. (2017). Long-term follow-up of psylocybin-
facilitated smoking cessation. The American Journal of Drug and Alcohol Abuse, 43(1),
55-60.
Johnson, M. W., Griffiths, R. R., Hendricks, P. S., & Henningfield, J. E. (2018). The abuse
potential of medical psilocybin according to the 8 factors of the Controlled Substances Act.
Neuropharmacology, 142, 143–166.
Labate, B. C., Cavnar, C., & Gearin, A. K. (Eds.). (2016). The world ayahuasca diaspora:
Reinventions and controversies. Taylor & Francis.
Luoma, J.B., Subucedo, P., Eriksson, J., Gates, N., & Pilecki, B. (in press). Toward a Contextual
Psychedelic Assisted Therapy: Contextual Behavioral Science and the Third Wave of
Psychedelic Research. Journal of Contextual Behavioral Science.
Mithoefer, M. C., Feduccia, A. A., Jerome, L., Mithoefer, A., Wagner, M., Walsh, Z., ... &
Doblin, R. (2019). MDMA-assisted psychotherapy for treatment of PTSD: study design and
rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled
trials. Psychopharmacology, 1-11.
Moriarty, K. M., Alagna, S. W., & Lake, C. R. (1984). Psychopharmacology: an historical
perspective. Psychiatric Clinics, 7(3), 411-433.
Pollan, M. (2018). How to change your mind: What the new science of psychedelics teaches us
about consciousness, dying, addiction, depression, and transcendence. Penguin Books.
Ross S., Bossis A., Guss J., Agin-Liebes G., Malone T., Cohen B., Mennenga, S.E., Belser, A.,
Kalliontzi, K., Babb, J., Su, Z., Corby, P, & Schmidt, B.L. (2016). Rapid and sustained
symptom reduction following psilocybin treatment for anxiety and depression in patients
with life-threatening cancer: a randomized controlled trial. Journal of
Running Head: Contextual Behavioral Science and Psychedelic Assisted Therapy Research
Psychopharmacology, 30(12), 1165-1180.
Sanches, R.F., de Lima Osorio, F., Santos, dos, R.G., Macedo, L.R.H., Maia-de- Oliveira, J.P.,
Wichert-Ana, L., de Araujo, D.B., Riba, J., Crippa, J.A.S., & Hallak, J.E.C. (2016).
Antidepressant effects of a single dose of ayahuasca in patients with recurrent depression:
A SPECT study. Journal of Clinical Psychopharmacology, 36(1), 77-81.
Sloshower, J., Guss, J., Krause, R., Wallace, R. M., Williams, M. T., Reed, S., & Skinta, M. D.
(in press). Psilocybin-Assisted Therapy of Major Depressive Disorder Using Acceptance
and Commitment Therapy as a Therapeutic Frame. Journal of Contextual Behavioral
Science.
Soler, J., Elices, M., Dominguez-Clavé, E., Pascual, J. C., Feilding, A., Navarro-Gil, M., …
Riba, J. (2018). Four weekly ayahuasca sessions lead to increases in “acceptance”
capacities: A comparison study with a standard 8-week mindfulness training program.
Frontiers in Pharmacology, 9, 1–8.
Watts, R., & Luoma, J.B. (in press). The Use of the Psychological Flexibility Model to Support
Psychedelic Assisted Therapy. Journal of Contextual Behavioral Science.
Zeifman, R. J., & Wagner, A. (in press). Exploring the Case for Research on Incorporating
Psychedelics Within Interventions for Borderline Personality Disorder. Journal of
Contextual Behavioral Science.
... Within this part of the protocol, the patient develops a relationship with the therapist(s) that is/are present for the dosing session. The patient is told what to expect, and often sets an 'intention' for the upcoming dosing session (Watts & Luoma, 2020). During the session, the patient ingests psilocybin (commonly 25-30mg as a high dose) in the presence of a therapist(s), who provides guidance and emotional support when needed. ...
... Succeeding the psychedelic session, a number of integration sessions are provided, FUTURE DIRECTIONS FOR CLINICAL PSYCHEDELIC RESEARCH 6 aiming to synthesise any insights from the experience, with the aim of integrating behavioural or cognitive changes that may lead to positive long-term mental health outcomes. While there has been some effort to standardise the therapeutic protocols associated with PAP (Watts & Luoma, 2020), further research is needed to verify the ideal way to deliver psychedelic therapy. ...
... It is beyond the scope of this review to summarise all of the clinical research that has used PAP to treat depressive disorders. We invite the reader to seek out the following references, which each provide a meta-analysis of PAP for depressive disorders (Goldberg et al., 2020;Vargas et al., 2020;Romeo et al., 2020;Luoma et al., 2020;Galvão-Coelho et al., 2021). While the observed effect sizes within these meta-analyses are consistently larger in magnitude than those associated with the use of psychotherapy alone (Cuijpers et al., 2008;Cuijpers et al., 2010), antidepressants (Fournier et al., 2010), or pharmacotherapy and psychotherapy combined (Cuijpers et al., 2014), it should be highlighted that these effect sizes in clinical psychedelic trials may be overestimated due to low sample sizes, or due to a lack of robust placebo-controls. ...
Future Directions for Clinical Psychedelic Research: The Relaxed Symptom Network
Preprint
Full-text available
  • May 2021
Recent clinical trials have demonstrated that psilocybin may have strong antidepressant effects, and may be effective in the treatment of depressive disorders when embedded in a psychotherapeutic protocol (psychedelic-assisted psychotherapy; PAP). There are now dozens of registered and ongoing clinical trials that intend to test for the efficacy of psilocybin within a psychotherapeutic protocol. Despite promising results, the mechanism(s) that may be responsible for the antidepressant effects of PAP are still hotly contested. In this paper, we provide a broad overview of the recent clinical work conducted with psychedelics on depressive disorders, and summarise several theories of action of PAP. Extending on the state of the field, we argue that the ‘Network Theory of Mental Disorders’ is a useful tool for clinical research with psychedelics. We hypothesise that, if PAP is successful, the connections between symptoms in a network will weaken, thereby rendering the patient less vulnerable to developing or relapsing into depression. We argue that application of the Network Theory may (a) provide deeper insights into the effects of PAP on specific symptom interactions, both on an interindividual and intraindividual basis, (b) generate fruitful hypotheses for the clinical action of PAP, and (c) provide a pre-emptive tool for making the most of ‘intentions’ preceding and during psychedelic experiences. These findings we hope will ultimately improve responsiveness and reduce relapse in response to this promising therapy.
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... Indeed, selfdissolution is accompanied by a relaxation of the beliefs that normally bias the processing of information (Carhart-Harris & Friston, 2019). It results in less constrained brain and mind and a broadened repertoire of thoughts and emotion that favor the emergence of new perspectives (Atasoy et al., 2017;Carhart-Harris & Friston, 2019;Watts & Luoma, 2020). In a controlled study, it has been shown that the psychedelics psilocybin produced more psychological insights compared to the atypical hallucinogen dextromethorphan (Carbonaro et al., 2018). ...
... Therefore, our results are in line with those that have demonstrated that experiential avoidance and psychological flexibility (Davis et al., , 2020b changes are important features of psychedelics' therapeutic outcomes (Wolff et al., 2020). It also support the proposals that integrating psychedelic administration with therapies designed to target psychological flexibility, such as Acceptance and Commitment Therapy (ACT, Hayes et al., 2006), could have a catalyzing effect on symptoms reduction (Luoma et al., 2019;Walsh & Thiessen, 2018;Watts & Luoma, 2020). In addition, our findings suggest that therapies which target self-compassion and have been shown efficient in reducing depression (Gilbert & Procter, 2006) and promoting well-being (Neff & Germer, 2013), such as compassion-focused therapy (CFT; Gilbert, 2009) and mindful self-compassion (MSC) program (Neff & Germer, 2013), could be integrated with psychedelics administration as well. ...
... Our findings have to be confirmed with more controlled studies just as the possibility that selfcompassion-based therapies could enhanced these therapeutic effects. However, because selfcompassion and self-rumination overlap with the concept of psychological flexibility, the present results add to the growing body of proposals that contextual behavioral science and related thirdwave cognitive behavioral therapies could be particularly suited in the context of psychedelicassisted therapies (Luoma et al., 2019;Walsh & Thiessen, 2018;Watts & Luoma, 2020). ...
Changes in Self-Rumination and Self-Compassion Mediate the Effect of Psychedelic Experiences on Decreases in Depression, Anxiety, and Stress
Article
Full-text available
  • May 2021
Psychedelic experiences can be associated with psychological health improvements, such as decreased depression, anxiety and stress (DAS). Indices indicate that mystical experience and psychological insights, two consistent phenomena of the psychedelics experience, could operate a shift from self-rumination toward self-compassion. Therefore, the present study tests the hypothesis that changes in self-rumination and self-compassion mediate the effects of mystical experience and psychological insights on decreases in DAS following a psychedelic experience. Online questionnaires were completed by individuals who reported having had a significant psychedelic experience (n = 164). We observed significant decreases in DAS after the psychedelic experience. We also observed a significant decrease in self-rumination and increase in self-compassion after the psychedelic experience. A regression analysis showed that the level of psychological insights experienced during the psychedelic session was significantly associated with decrease in DAS. A mediation analysis revealed that decreases in self-rumination and increases in self-compassion partially mediated the effect of psychological insights on decreases in DAS. Although there was an increase in self-reflection following the psychedelic experience, it was not associated with decreases in DAS. This suggests that decreases in self-rumination and increases in self-compassion may be partial mediators of the effects of psychedelics on DAS. Self-compassion shared similarities with psychological flexibility, and self-compassion focused therapies have been shown efficient to decrease DAS. Therefore, we propose that our results bring additional support for the use of contextual behavioral science and related third waves cognitive-behavioral therapies to get the best benefits of psychedelic effects in the context of psychedelic-assisted therapy.
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... Part of the efficacy of psychedelics when utilised in a therapeutic context appears to be through their capacity to act as catalysts or amplifiers of psychotherapeutic practices and processes (Grof, 1980;Sloshower et al., 2020;Watts et al., 2017;Watts and Luoma, 2020). Nature seems to also act as an amplifier of therapeutic effect: one study found that cognitive behaviour therapy (CBT)-based psychotherapy applied in a forest environment was helpful in achievement of remission of major depression among sufferers, with the forest setting enhancing the effect of the psychotherapeutic intervention when compared to a clinical hospital setting (Kim et al., 2009). ...
... The purpose of psychedelic preparation sessions is to establish trust between the person who will be having the psilocybin experience and the therapists who will be supporting them through the psychedelic session. Preparation sessions usually take place the day before, and include psychoeducation about the likely effects of psilocybin, discussion of the participant's intentions for the upcoming session, and some time for establishing therapeutic rapport (Watts and Luoma, 2020). Horticulture exercises (Scott, 2015) may be a perfect complement to a preparation session; that is, 'preparing the ground' for the work to come. ...
... Recognition of this can be life changing for people who suffer from depression. Metaphors about nature have been incorporated into the ACE model for psilocybin for depression (Watts and Luoma, 2020), an upcoming therapy model for group settings, and an upcoming extended integration model. ...
The potential synergistic effects between psychedelic administration and nature contact for the improvement of mental health
Article
Full-text available
  • Dec 2020
Therapeutic psychedelic administration and contact with nature have been associated with the same psychological mechanisms: decreased rumination and negative affect, enhanced psychological connectedness and mindfulness-related capacities, and heightened states of awe and transcendent experiences, all processes linked to improvements in mental health amongst clinical and healthy populations. Nature-based settings can have inherently psychologically soothing properties which may complement all stages of psychedelic therapy (mainly preparation and integration) whilst potentiating increases in nature relatedness, with associated psychological benefits. Maximising enhancement of nature relatedness through therapeutic psychedelic administration may constitute an independent and complementary pathway towards improvements in mental health that can be elicited by psychedelics.
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... According to the cognitive-behavioral model [74] illustrated in Fig. 2, metacognitive assumptions which are temporarily destabilized during the psychedelic state can be permanently and positively shifted by confrontation with previously avoided experiential content, as often appears to occur in psychedelic therapy even without specific intervention by the therapist [78][79][80]. Of central importance here is the observation that during the psychedelic experience, attempts to avoid aversive experiential content often lead to increased aversion, whereas a mindful, accepting attitude typically warrants a less tormenting experience [74,78,[81][82][83]. Hence, a form of operant conditioning takes place, making possible deep and largely avoidancefree engagement with distressing feelings, thoughts, memories, and body perceptions. ...
... Against the backdrop of increasing evidence for positive synergistic effects between psychedelic interventions and mindfulness practices, as well as acceptancepromoting effects of psychedelics [78,[86][87][88][89], efforts to combine psychedelic-assisted interventions with the socalled "third-wave procedures" within CBT have recently increased [90]. This is especially true for the combination of psilocybin with acceptance and commitment therapy (ACT), whose basic features and therapeutic goals show numerous overlaps with the phenomenology of psychedelic states [81,91]. Correspondingly, sophisticated therapeutic concepts are currently being tested in clinical trials. ...
Novel Treatment Approaches for Substance Use Disorders: Therapeutic Use of Psychedelics and the Role of Psychotherapy
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Full-text available
  • Mar 2022
Purpose of Review The use of psychedelics in a therapeutical setting has been reported for the treatment of various diagnoses in recent years. However, as psychedelic substances are still commonly known for their (illicit) recreational use, it may seem counterintuitive to use psychedelic therapy to treat substance use disorders. This review aims to discuss how psychedelics can promote and intensify psychotherapeutic key processes, in different approaches like psychodynamic and cognitive behavioral therapy, with a spotlight on the treatment of substance use disorders (SUD). Recent Findings There is promising evidence of feasibility, safety, and efficacy of psychedelic therapy in SUD. In the whole process of former and current psychedelic therapy regimes that have shown to be safe and efficacious, various psychotherapeutic elements, both psychodynamic and behavioral as well as other approaches, can be identified, while a substantial part of the assumed mechanism of action, the individual psychedelic experience, cannot be distinctly classified to just one approach. Summary Psychedelic therapy consists of a complex interaction of pharmacological and psychological processes. When administered in well-defined conditions, psychedelics can serve as augmentation of different psychotherapy interventions in the treatment of SUD and other mental disorders, regardless of their theoretical origin.
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... Regarding objection four, unfamiliarity with concepts from cognitive-behavioral approaches that are relevant to psychedelic treatments, we acknowledge that not all researchers and clinicians have had exposure to cognitive-behavioral approaches (e.g., CBT, DBT, ACT) and particularly how cognitive-behavioral approaches are capable of addressing the unique characteristics involved in psychedelic assisted psychotherapy, such as spiritual experiences (see Luoma et al., 2020). Furthermore, we recognize that there are a great number of popular books and articles advocating for the pairing of psychedelic treatments with indigenous practices, new age spirituality, and psychodynamic approaches--and that there is a relative paucity of such resources for cognitive-behavioral approaches in the domain of psychedelic treatments. ...
Psychedelics and Psychotherapy: Cognitive-Behavioral Approaches as Default
Article
Full-text available
  • May 2022
The acute subjective effects of psychedelics are responsive to users’ expectations and surroundings (i.e., “set and setting”). Accordingly, a great deal of thought has gone into designing the psychosocial context of psychedelic administration in clinical settings. But what theoretical paradigms inform these considerations about set and setting? Here, we describe several historical, sociological influences on current psychedelic administration in mainstream European and American clinical research settings, including: indigenous practices, new age spirituality from the 1960s, psychodynamic/psychoanalytic approaches, and cognitive-behavioral approaches. We consider each of these paradigms and determine that cognitive-behavioral therapies, including newer branches such as acceptance and commitment therapy (ACT), have the strongest rationale for psychedelic-assisted psychotherapy going forward. Our primary reasons for advocating for cognitive-behavioral approaches include, (1) they avoid issues of cultural insensitivity, (2) they make minimal speculative assumptions about the nature of the mind and reality, (3) they have the largest base of empirical support for their safety and effectiveness outside of psychedelic therapy. We then propose several concepts from cognitive-behavioral therapies such as CBT, DBT, and ACT that can usefully inform the preparation, session, and integration phases of psychedelic psychotherapy. Overall, while there are many sources from which psychedelic psychotherapy could draw, we argue that current gold-standard, evidence-based psychotherapeutic paradigms provide the best starting point in terms of safety and efficacy.
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... Psychedelic therapy trials are generating data we suggest could fruitfully be conceptualized through the framework of the sensitivity of therapeutic altered states to suggestion. This connects several literatures: a tradition of psychedelic research that proposes the drugs produce states of heightened suggestibility against a longer historical interest in hypnosis (21)(22)(23)(24); psychedelics as psychoplastogens, increasing cognitive and emotional flexibility (25)(26)(27)); the field of placebo studies (28)(29)(30); ritual theory (31,32) and the study of "common factors" across psychotherapies (33) alongside other process-oriented research into psychological change. By bringing these literatures into a fuller encounter, we imagine a range of conceptual distinctions, methodological considerations, and theories, animating new directions for psychedelic therapy research. ...
New Frontiers or a Bursting Bubble? Psychedelic Therapy Beyond the Dichotomy
Article
Full-text available
  • Sep 2021
This opinion piece reflects on the question of whether psychedelic therapies will ‘open a new frontier’ in mental healthcare or whether the bubble will ‘burst.’ Our goal is to overcome any stark opposition implied between these scenarios, in order to foster greater critical discourse about the broader economic, cultural and regulatory forces shaping psychedelic research. The usual framing of psychedelic therapies being a bubble that may burst evokes the drug prohibitionism that emerged during the 1960s. While the possibility of political backlash against the growing use of psychedelics outside of research settings certainly exists, we suggest that the contemporary context differs from that of the 1960s in key ways. Nevertheless, today’s bubble presents its own challenges, and we trace how these will grow as psychedelic therapy continues to move towards post-approval service provision. We caution that this should not be taken to mean that psychedelics do not offer new frontiers in mental healthcare. On the contrary, we outline four areas in which – even if psychedelic therapies are not enrolled into treatment modalities to the extent currently anticipated – they have the potential to transform mental healthcare: first, through the development of a host of novel (psychoactive and non-psychoactive) psychiatric drugs derived through research into psychedelic compounds; second, by elucidating the sensitivity of therapeutic altered states to suggestion; third, by fostering the potential for a much deeper recognition of the role of care structures in mental healthcare; fourth, by encouraging possibilities for more dynamic and interconnected, rather than static and siloed, systems for the regulation of psychoactive drugs writ-large. By integrating the bubble’s shadow before it bursts, psychedelic therapies’ potential to heal patients and re-invigorate Western psychiatry might be better realised.
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... Studies using such instruments as the FFMQ and the EQ have found that a single carefully conducted psychedelic experience, or very few such experiences, can significantly increase mindfulnessrelated capacities-that is, capacities for decentering, non-judging, and so on-for weeks or months (Mian et al. 2020, Murphy-Beiner and Soar 2020, Soler et al. 2016, Sampedro et al. 2017, Uthaug et al. 2018, Madsen et al. 2020, González et al. 2020). This coheres with findings that psychedelic experiences can durably increase psychological flexibility, a construct that is closely related to decentering (Davis et al. 2020, Watts andLuoma 2020). It is worth emphasising that most of these studies include no explicit mindfulness training. ...
Psychedelics and meditation: a neurophilosophical perspective
Chapter
Full-text available
  • Jul 2022
Psychedelic ingestion and meditative practice are both ancient methods for altering consciousness that became widely known in Western society in the second half of the 20th century. Do the similarities begin and end there, or do these methods – as many have claimed over the years – share some deeper common elements? In this chapter I take a neurophilosophical approach to this question and argue that there are, indeed, deeper commonalities. Recent empirical studies show that psychedelics and meditation modulate overlapping brain networks involved in the sense of self, salience, and attention; moreover, psychedelics can occasion lasting increases in “mindfulness-related capacities” for taking a non-reactive stance on one’s inner experience (e.g. Sampedro et al. 2017). The self-binding theory of psychedelic ego dissolution (Letheby and Gerrans 2017) offers a plausible explanation of these findings: by disrupting self-related beliefs implemented in high-level cortical networks, both psychedelics and meditation can “unbind” mental contents from one’s self-model, moving these contents along the continuum from phenomenal transparency to opacity (cf. Metzinger 2003). In other words, both psychedelics and meditation can expose and weaken our foundational beliefs about our own identity, allowing us to disidentify with these beliefs and see them as “just thoughts”. There are connections between these ideas and recent arguments suggesting that psychedelic use may have epistemic benefits consistent with philosophical naturalism (Letheby 2015, 2016, 2019). I conclude with a proposal: these connections may help in thinking about the putative epistemic benefits of meditation practice from a naturalistic perspective.
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... Individuals need to acknowledge both positive and negative emotions in order to manage their emotions and maintain emotional balance (Veilleux et al., 2020). Unrecognized and suppressed emotions, specifically negative ones, have been known to contribute to maladjusted behaviors and social communication impairments (Gersons, Nijdam, Smid, & Meewisse, 2020;Kwon, Chung, & Kim, 2020;Watts & Luoma, 2020). ...
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... "Third wave" psychotherapies, such as Acceptance and Commitment Therapy (ACT), may be particularly relevant here (93,94). Hence, rather than looking at behavioural interventions and the application of psychedelics as separate pathways of achieving a similar goal, it is suggested that they may be harmonised (95)(96)(97). Traditional methods for training mindfulness skills may be complemented directly or indirectly via psychedelic use or therapy, aiming to protect well-being. ...
Sustained, Multifaceted Improvements in Mental Well-Being Following Psychedelic Experiences in a Prospective Opportunity Sample
Article
Full-text available
  • Jun 2021
In the last 15 years, psychedelic substances, such as LSD and psilocybin, have regained legitimacy in clinical research. In the general population as well as across various psychiatric populations, mental well-being has been found to significantly improve after a psychedelic experience. Mental well-being has large socioeconomic relevance, but it is a complex, multifaceted construct. In this naturalistic observational study, a comprehensive approach was taken to assessing well-being before and after a taking a psychedelic compound to induce a “psychedelic experience.” Fourteen measures of well-being related constructs were included in order to examine the breadth and specificity of change in well-being. This change was then analysed to examine clusters of measures changing together. Survey data was collected from volunteers that intended to take a psychedelic. Four key time points were analysed: 1 week before and 2 weeks, 4 weeks, and 2 years after the experience (N = 654, N = 315, N = 212, and N = 64, respectively). Change on the included measures was found to cluster into three factors which we labelled: 1) “Being well”, 2) “Staying well,” and 3) “Spirituality.” Repeated Measures Multivariate Analysis of Variance revealed all but the spirituality factor to be improved in the weeks following the psychedelic experience. Additional Mixed model analyses revealed selective increases in Being Well and Staying Well (but not Spirituality) that remained statistically significant up to 2 years post-experience, albeit with high attrition rates. Post-hoc examination suggested that attrition was not due to differential acute experiences or mental-health changes in those who dropped out vs. those who did not. These findings suggest that psychedelics can have a broad, robust and sustained positive impact on mental well-being in those that have a prior intention to use a psychedelic compound. Public policy implications are discussed.
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The use of the psychological flexibility model to support psychedelic assisted therapy
Article
Full-text available
  • Jan 2020
Psychedelic assisted therapy comprises three stages: Preparation, Psychedelic Session, and Integration. Preparation is key for maximising the potential of a beneficial psychedelic experience and integration is important for prolonging improvements. The psychological flexibility model (PFM) appears to be a promising one to guide psychedelic preparation and integration. This paper proposes a model that utilises the PFM as informed by a previously published qualitative study of patient accounts of change processes in psilocybin therapy that identified themes of acceptance and connection as associated with positive outcomes. This new model, the ACE (Accept, Connect, Embody) model presents the six psychological flexibility processes, renamed and rearranged in an acceptance triad (defusion, present moment focus, willingness) and a connection triad (self as context, values, committed action). This paper describes the ACE model and how it is being used in an ongoing trial of psilocybin treatment for major depression. It also describes qualitative evidence supportive of the idea that psychological flexibility may be key to characterizing the processes of change involved in psilocybin assisted therapy for depression. These and other results suggest that psilocybin may be specifically increasing psychological flexibility and point to the possibility that psychotherapy approaches incorporating the PFM may serve as a means to deepen and extend the benefits of psilocybin treatment, thus bridging the experiential gap between a potent inner experience and an outer life better lived.
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Exploring the case for research on incorporating psychedelics within interventions for borderline personality disorder
Article
Full-text available
  • Jan 2020
Borderline Personality Disorder (BPD) is a severe psychiatric disorder characterized by behavioral dysregulation, emotion dysregulation, disturbances in self-identity, and social functioning. Despite the existence of evidence-based psychotherapeutic interventions for BPD, these interventions have important limitations (e.g., limited treatment efficacy). Furthermore, little evidence exists for the efficaciousness of pharmacological interventions for BPD. Thus, a strong need for improving current interventions for BPD exists. Although research incorporating psychedelics within interventions for a wide range of psychiatric disorders has shown promise, research has not yet explored the utility of incorporating psychedelics within interventions for BPD. Therefore, this paper reviews the impact of psychedelics on treatment targets in interventions for BPD (i.e., behavioral dysregulation, emotion dysregulation, disturbances in self-identity, and social functioning), as well as purported overlapping mechanisms of change between interventions for BPD and psychedelics (i.e., emotion dysregulation, mindfulness, and self-compassion). Finally, safety concerns, clinical recommendations, and proposed next research steps related to the administration of psychedelics to individuals with BPD are discussed. This paper aims to explore the case for conducting research on, and the potential clinical utility surrounding, incorporating psychedelics within interventions for BPD.
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Psilocybin-assisted therapy of major depressive disorder using Acceptance and Commitment Therapy as a therapeutic frame
Article
Full-text available
  • Nov 2019
ABSTRACT Psychedelic-assisted therapy is based on the premise that psychedelic substances can act as catalysts or adjuncts to psychotherapeutic processes. Recent clinical trials involving psychedelic-assisted therapy have generally employed a similar three-part structure consisting of preparation, support during the dosing sessions, and subsequent “integration.” However, the content of these sessions and the frame through which the therapists approach participants and understand the clinical process has thus far been inconsistent among studies. In designing a manualized therapy protocol for a small clinical trial of psilocybin-assisted therapy for major depressive disorder, our group sought to delineate an explicit and replicable, evidence-based model that intentionally builds upon both the neurobiological actions of the medication and the phenomenology of the drug experience. Having identified considerable concordance in proposed mechanisms of change between Acceptance and Commitment Therapy (ACT) and psilocybin therapy, we employed ACT as an overarching psychotherapeutic framework. We hypothesize that the psilocybin experience can provide direct experiential contact with ACT processes that increase psychological flexibility, and that these deeply felt experiences may in turn be reinforced during ACT-informed follow-up therapy sessions. In this paper, we describe the rationale for selecting ACT, areas of potential synergism between ACT and psilocybin-therapy, the basic structure of our treatment model, and limitations to this approach.
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RETRACTED ARTICLE: MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials
Article
Full-text available
  • May 2019
  • PSYCHOPHARMACOLOGY
Background Posttraumatic stress disorder is a prevalent mental health condition with substantial impact on daily functioning that lacks sufficient treatment options. Here we evaluate six phase 2 trials in a pooled analysis to determine the study design for phase 3 trials of MDMA-assisted psychotherapy for PTSD. Methods Six randomized, double-blind, controlled clinical trials at five study sites were conducted from April 2004 to February 2017. Active doses of MDMA (75–125 mg, n = 72) or placebo/control doses (0–40 mg, n = 31) were administered to individuals with PTSD during manualized psychotherapy sessions in two or three 8-h sessions spaced a month apart. Three non-drug 90-min therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session. Results After two blinded experimental sessions, the active group had significantly greater reductions in CAPS-IV total scores from baseline than the control group [MMRM estimated mean difference (SE) between groups − 22.0 (5.17), P < 0.001]. The between-group Cohen’s d effect size was 0.8, indicating a large treatment effect. After two experimental sessions, more participants in the active group (54.2%) did not meet CAPS-IV PTSD diagnostic criteria than the control group (22.6%). Depression symptom improvement on the BDI-II was greatest for the active group compared to the control group, although only trended towards significant group differences [MMRM, estimated mean difference (SE) between groups − 6.0 (3.03), P = 0.053]. All doses of MDMA were well tolerated, with some expected reactions occurring at greater frequency for the active MDMA group during experimental sessions and the 7 days following. Conclusions MDMA-assisted psychotherapy was efficacious and well tolerated in a large sample of adults with PTSD. These studies supported expansion into phase 3 trials and led to FDA granting Breakthrough Therapy designation for this promising treatment. Trial registration ClinicalTrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.
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The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act
Article
Full-text available
  • May 2018
Conclusions: (1) psilocybin has an abuse potential appropriate for CSA scheduling if approved as medicine; (2) psilocybin can provide therapeutic benefits that may support the development of an approvable New Drug Application (NDA) but further studies are required which this review describes; (3) adverse effects of medical psilocybin are relatively low and manageable when administered according to risk management approaches; and (4) although further study is required, this review suggests that placement in Schedule IV may be appropriate if a psilocybin-containing medicine is approved.
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Four Weekly Ayahuasca Sessions Lead to Increases in “Acceptance” Capacities: A Comparison Study With a Standard 8-Week Mindfulness Training Program
Article
Full-text available
  • Mar 2018
Background: The therapeutic effects of the Amazonian plant tea ayahuasca may relate to its ability to enhance mindfulness capacities. Ayahuasca induces a modified state of awareness through the combined action of its active principles: the psychedelic N,N-dimethyltryptamine (DMT) and a series of centrally acting β-carbolines, mainly harmine and tetrahydroharmine. To better understand the therapeutic potential of ayahuasca, here we compared the impact on mindfulness capacities induced by two independent interventions: (a) participation in four ayahuasca sessions without any specific purpose related to improving mindfulness capacities; and (b) participation in a standard mindfulness training course: 8 weeks mindfulness-based stress reduction (MBSR), with the specific goal of improving these skills. Methods: Participants of two independent groups completed two self-report instruments: The Five Facet Mindfulness Questionnaire (FFMQ) and the Experiences Questionnaire (EQ). The MINDSENS Composite Index was also calculated, including those EQ and FFMQ items that have proven to be the most sensitive to meditation practice. Group A (n = 10) was assessed before and after the last of four closely spaced consecutive ayahuasca sessions. Group B (n = 10) was assessed before and after completion of a standard 8-week MBSR course. Results: MBSR training led to greater increases in overall mindfulness scores after the 8-week period. MBSR but not ayahuasca led to increases in the MINDSENS Composite Index. However, the ayahuasca sessions induced comparable increases in the Non-Judging subscale of the FFMQ, specifically measuring “acceptance.” Improving this capacity allows for a more detached and less judgmental stance toward potentially distressing thoughts and emotions. Results: The present findings suggest that a small number of ayahuasca sessions can be as effective at improving acceptance as more lengthy and costly interventions. Future studies should address the benefits of combining ayahuasca administration with mindfulness-based interventions. This will allow us to investigate if ayahuasca will improve the outcome of psychotherapeutic interventions.
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Psychological flexibility mediates the relations between acute psychedelic effects and subjective decreases in depression and anxiety
Article
  • Nov 2019
Prior research has shown that acute subjective psychedelic effects are associated with both spontaneous and intended changes in depression and anxiety. Psychedelics are also theorized to produce increases in psychological flexibility, which could explain decreases in depression and anxiety following a psychedelic experience. Therefore, the present cross-sectional survey study sought to examine whether psychological flexibility mediated the relationship between acute psychedelic experiences and spontaneous or intended changes in depression and anxiety among a large international sample of people who reported having used a psychedelic (n=985; male=71.6%; Caucasian/white=84.1%; Mage=32.2, SD=12.6). A regression analysis showed that acute effects (i.e., mystical and insightful effects) were significantly associated with decreases in depression/anxiety following a psychedelic experience. A path analysis revealed that, while controlling for age and sex, increases in psychological flexibility fully mediated the effect of mystical and insightful experiences on decreases in depression and anxiety following a psychedelic experience. This suggests that psychological flexibility may be an important mediator of the therapeutic effects of psychedelic drugs. Future prospective experimental studies should examine the effect of psychedelic drug administration on psychological flexibility in order to gain a better understanding of the psychological processes that predict therapeutic effects of psychedelics.
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Efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic stress disorder: A systematic review and meta-analysis
Article
  • Aug 2019
  • PROG NEURO-PSYCHOPH
BACKGROUND: Posttraumatic stress disorder (PTSD) is a common psychiatric condition that can develop following a traumatic experience. PTSD is associated with significant disability, a large economic burden, and despite the range of therapies to treat PTSD, response to antidepressants is limited. A growing body of clinical research suggests the efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in individuals with treatment-refractory PTSD. AIM: To assess the effectiveness and safety of MDMA-assisted psychotherapy for reducing symptoms of PTSD, a systematic review and meta-analysis was undertaken. METHODS: Six online databases were searched from inception to December 2018. Reference lists of relevant articles were manually searched as well as electronic sources of ongoing trials and conference proceedings. Researchers active in the subject were also contacted. Eligible studies included randomized and quasi-randomized clinical trials using MDMA-assisted psychotherapy for PTSD in comparison with other medications, placebo or no medication (supportive care). We used standard methodological procedures expected by the Cochrane Collaboration. Two authors assessed studies for inclusion and extracted data. Using random-effects meta-analysis with Cochrane's Review Manager 5.3, we obtained standardized mean differences [SMD] and rate ratios [RR] for reduction in PTSD symptomatology. RESULTS: A total of 5 trials met inclusion criteria, totaling 106 participants (average age: 35-40 years, 70% female). Studies were rated as moderate in quality. MDMA-assisted psychotherapy demonstrated a high rate of clinical response (RR = 3.47, 95% CI: 1.70, 7.06), remission (RR = 2.63, 95% CI: 1.37, 5.02), with a large effect size at reducing the symptoms of PTSD (SMD = 1.30, 95% CI: 0.66, 1.94). Available evidence indicates that MDMA was well-tolerated, with few serious adverse events reported across studies. CONCLUSIONS: MDMA-assisted psychotherapy appears to be a potentially safe, effective, and durable treatment for individuals with chronic, treatment-refractory PTSD. However, future studies involving larger samples and longer durations of treatment and follow-up are warranted-and underway.
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