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Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial on the ASSYST Treatment Intervention

Authors:
  • Independent Researcher

Abstract

The aim of this randomized controlled trial with an intention-to-treat analysis was to evaluate the effectiveness, efficiency, and safety of the Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD), anxiety, and depression symptoms in adult females with breast or cervical cancer.
Research Article
Volume 25 Issue 5 - January 2024
DOI: 10.19080/CTOIJ.2024.25.556175
Cancer Ther Oncol Int J
Copyright © All rights are reserved by Ross Jessica
Breast And Cervical Cancer-Related PTSD:
Randomized Controlled Trial on the ASSYST
Treatment Intervention
Ross J1*, Navarro F1, Mainthow N2, Givaudan M2 and Jarero I2
1Ágape, Desarrollo Integral, AC, Puebla, México
2Department of Research, EMDR Mexico, Mexico City, Mexico
Submission: November 09, 2023; Published: January 08, 2024
*Corresponding author: Ross Jessica, Ágape, Desarrollo Integral, AC, Puebla México
Cancer Ther Oncol Int J 25(5): CTOIJ.MS.ID.556175 (2024) 001
Cancer Therapy & Oncology
International Journal
ISSN: 2473-554X
Abstract
       
Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD), anxiety,
and depression symptoms in adult females with breast or cervical cancer. A total of 30 adult females met the inclusion criteria and participated
in the study. Participants’ ages ranged from 37 to 62 years old (M =48.63 years old). A two-arm randomized controlled trial (RCT) design was
applied. PTSD, anxiety, and depression symptoms were measured in three time points for all participants in the study. Repeated-measures

          



   
more likely to belong to the non-PTSD population after the intervention. Conversely, the control group participants are more likely to belong

anxiety, and depression symptoms in adult females with breast or cervical cancer. No adverse effects or events were reported by the participants

symptoms after treatment. Participants in the control group were invited to receive the intervention treatment after the follow-up assessment,

Keywords: Acute Stress Syndrome Stabilization; ASSYST; Posttraumatic stress disorder (PTSD); Anxiety; Depression; Breast Cancer; Cervical
Cancer
Abbreviations: PTSD: Posttraumatic Stress Disorder; RCT: Randomized Controlled Trial; ASSYST-I: Acute Stress Syndrome Stabilization
                
Manual; AIP: Adaptive Information Processing; EMDR-PRECI: EMDR Protocol for Recent Critical Incidents and Ongoing Traumatic Stress;
ASD: Acute Stress Disorder; SPIRIT: Standard Protocol Items Recommendation for Interventional Trials; CONSORT: Consolidated Standards of
Reporting Trials; ANOVA: Analyses of variance; HADS: Hospital Anxiety and Depression Scale; CAPS-5: Clinician-Administered PTSD Scale-5;
PCL-5: Posttraumatic Stress Disorder Checklist for DSM-5
Introduction
As of 2020, female breast cancer is the most prevalent type
of cancer, as well as one of the deadliest among females, with 7.8
million women diagnosed and 685,000 deaths, while cervical
cancer is the fourth most common cancer in women, with about
570,000 women diagnosed and about 311, 000 deaths in 2018 [1-
2]. The diagnosis of female breast cancer can have catastrophic
implications and severe life impediments, no matter the
developmental life cycle of the female diagnosed, particularly with
  
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
002
Cancer erapy & Oncology International Journal
treatment, the experience of breast cancer for women is distressing
and disruptive, causing psychological and functional impairment
that is found to not only remain, but increase over time, long
after treatment has been terminated, ranging from fear of cancer
      
(PTSD) [4-6], while cervical cancer has also been linked to PTSD
symptoms [7]. It is important to note that while the diagnosis
of a life-threatening illness is considered a criterion A event for
PTSD in the Diagnostic and Statistical Manual (DSM)-IV, and the
diagnosis of cancer met criterion A, there is discrepancy as to
whether or not breast or cervical cancer diagnosis meets criterion
A for PTSD, as the diagnosis of a life-threatening illness must be
considered “sudden and catastrophic,” and the diagnosis of cancer
is not considered a PTSD criterion A event in the DSM-5 [8-9].
However, breast cancer diagnosis is sudden and catastrophic for
most women, given the high mortality rate, treatment trajectory,
and disruption of daily life [5]. This discrepancy does not negate
the evidence for the rampancy of PTSD intrusion symptoms and
their detrimental effects on the quality of life and functioning of

paper, we will explore the recruitment and treatment of PTSD,
anxiety, and depression symptoms provoked by breast cancer
or cervical cancer diagnosis and treatment (e.g., surgery and
chemotherapy).
     
cancer diagnosis, particularly female breast cancer, and PTSD
symptoms [10-16]. Studies show that PTSD intrusion symptoms,
most reported as, but not limited to nightmares and extreme
       
most pervasive symptoms of the experienced symptom clusters
among cancer patients, with a prevalence of 11–45%. Also, 34.1%
of the patients who developed PTSD symptoms shortly after
their breast cancer diagnosis had no change or had exacerbated

that PTSD symptoms in this population do not subside with time
and that treatment intervention procedures for cancer-related
         
that given the amount of evidence correlating female breast
cancer, cervical cancer, and other types of cancer and PTSD
symptoms, there are no treatment guidelines for cancer-related
PTSD symptoms. In a systematic review of 508 studies, only
eight met the inclusion criteria, albeit with study limitations,
      
of psychological interventions in treating cancer-related PTSD
symptoms [18]. Treatment intervention procedures to reduce or
eliminate cancer-related PTSD symptoms could have long-lasting

Acute Stress Syndrome Stabilization Individual
Treatment Intervention
The Acute Stress Syndrome Stabilization Individual
(ASSYST-I) treatment intervention is an adaptive information
processing (AIP)-informed, evidence-based, symptom-focused,
trauma-sensitive approach, which contains the core components
(the most therapeutically active) of the EMDR Protocol for Recent
Critical Incidents and Ongoing Traumatic Stress (EMDR-PRECI)
[19-31]. The ASSYST-I requires less time than the full EMDR
standard protocol or the EMDR-PRECI, making it less expensive,

of delivering brief treatment in primary care settings worldwide.
       
in-person or online support to clients who present PTSD or
Acute Stress Disorder (ASD), intense psychological distress, and/
or physiological reactivity caused by the disorders’ intrusion
symptoms associated with the memories of the traumatic event(s)
or adverse experience(s). Intrusion symptoms are core ASD and
PTSD dimensions and may cause extreme distress, functional
impairment, or dissociation from present surroundings. Therefore,

to trauma [32], as “reducing intrusion symptoms may also have
useful downstream effects since they are hypothesized to be a
mediator of other PTSD symptom clusters” [33,p.2].
Previous ASSYST Treatment Intervention Studies
Eight previous studies on the ASSYST treatment interventions
with 362 participants among different populations have proven

i. General population in lockdown and with ongoing
traumatic stress during the COVID-19 Pandemic.
ii. TeleMental Health counseling to the general population
after adverse experiences.
iii. Mental Health Professionals working during the
COVID-19 Pandemic with patients suffering from trauma-related
disorders and stressors.
iv. General population with non-recent pathogenic
memories.
v. Adult Syrian refugees living in Lebanon.
vi. 
vii. Public sector workers during the COVID-19 Pandemic.
viii.  
experiences, neglect, and maltreatment [34-41].
t Change
Margin
To know whether PTSD symptom change does indeed indicate


(CSC) Margin. The RCI determines if the magnitude of observed
change over time on a given measure is beyond what should be
attributed to measurement error. The CSC is used to determine
if an observed end score on a measure of symptomatology
003
Cancer erapy & Oncology International Journal
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
indicates that the respondent is more likely to belong to the non-
       
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), the
more conservative value of the RCI is 18 points and an end score

Objective
The objective of this randomized controlled trial with an
intention-to-treat analysis was to evaluate the effectiveness,
  
Individual (ASSYST-I) treatment intervention in reducing PTSD,
anxiety, and depression symptoms in adult females with breast or
cervical cancer.
Method
Study Design
To measure the effectiveness of the ASSYST-I on the dependent
variable PTSD, anxiety, and depression symptoms, this study,
with an intention-to-treat analysis, used a two-arm randomized
controlled trial (RCT) with a waitlist no-treatment control group
design. PTSD, anxiety, and depression symptoms were measured
at three-time points for all participants in the study: Time 1. Pre-
treatment assessment; Time 2. Post-treatment assessment; and

in the control group were invited to receive treatment intervention
after the follow-up assessment was completed.
Ethics and Research Quality
The study protocol and detailed procedures were reviewed
and approved by the EMDR Mexico International Research Ethics
Review Board (also known in the United States of America as an
Institutional Review Board) in compliance with the International
Committee of Medical Journal Editors recommendations, the
Guidelines for Good Clinical Practice of the European Medicines
Agency (version 1 December 2016), and the Helsinki Declaration
as revised in 2013. The research quality of this study was based on
the Consolidated Standards of Reporting Trials (CONSORT) 2010
Statement and the Standard Protocol Items Recommendation for
Interventional Trials (SPIRIT) 2013 checklist [43,44].
Participants
This study was conducted in Puebla City, Mexico, from June
to September 2023, with the Mexican (Latina) adult female
population with a breast or cervical cancer diagnosis and
     
potential participants were recruited. Inclusion criteria was:
a. Being an adult female
b. Having received a breast or cervical cancer diagnosis
and subsequent treatment
c. Voluntarily participating in the study
d. Not receiving specialized trauma therapy
e. Not receiving pharmacotherapy for PTSD symptoms
f. Having a PCL-5 total score of 31 points or more.
Exclusion criteria was:
a. Ongoing self-harm/suicidal or homicidal ideation
b. Diagnosis of schizophrenia, psychotic, or bipolar
disorder
c. Diagnosis of a dissociative disorder
d. Organic mental disorder
e. A current, active chemical dependency problem
f. 
disability, dementia)
g. Presence of uncontrolled symptoms due to a medical
illness.
         
wanting to participate in the study. A total of 30 adult females met
the inclusion criteria and participated in the study. Participants’
ages ranged from 37 to 62 years old (M =40.63 years). Participation
was voluntary, with the participants signing informed consent
before treatment per the Mental Capacity Act 2005.
Instruments for Psychometric Evaluation
a. To measure PTSD symptom severity and treatment
response, we used the Posttraumatic Stress Disorder Checklist
for DSM-5 (PCL-5) provided by the National Center for PTSD
(NCPTSD), with the time interval for symptoms to be the past
week. The instrument was translated and back translated to
Spanish. It contains 20 items, including three new PTSD symptoms
(compared with the PTSD Checklist for DSM-IV) [45,46]: blame,
negative emotions, and reckless or self-destructive behavior.
Respondents indicated how much they have been bothered by
each PTSD symptom over the past week (rather than the past
month), using a 5-point Likert scale ranging from 0=not at all, 1=a
little bit, 2=moderately, 3=quite a bit, and 4=extremely. A total
symptom score of zero to 80 can be obtained by summing the
items. The sum of the scores yields a continuous measure of PTSD
symptom severity for symptom clusters and the whole disorder.
Psychometrics for the PCL-5, validated against the Clinician-
Administered PTSD Scale-5 (CAPS-5) diagnosis, suggest that a
score of 31-33 is optimal to determine probable PTSD diagnosis
[47].
b. To measure anxiety and depression symptom severity and
treatment response, we used the Hospital Anxiety and Depression
Scale (HADS), extensively used to evaluate these psychiatric
comorbidities in various clinical settings at all healthcare services
and with the general population. The instrument was translated
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
004
Cancer erapy & Oncology International Journal
and back translated to Spanish. It is a 14-item self-report scale to
measure Anxiety (7 items) and Depression (7 items) of patients
with both somatic and mental problems using a 4-point Likert
scale ranging from 0 to 3. The response descriptors of all items are
  
(score 1); No, not at all (score 0). A higher score represents higher
levels of Anxiety and Depression: a domain score of 11 or greater
indicates Anxiety or Depression; 8–10 indicates a borderline case;
7 or lower indicates no signs of Anxiety or Depression [48,49].
Procedure
Randomization, Allocation Concealment Mechanism, and
Blinding Procedure
A computer-generated simple randomization with a 1:1
allocation ratio was used. Two independent assessors blind to
treatment conditions conducted the randomization process to
      
sequence was concealed using sequentially numbered, opaque,
sealed, and stapled envelopes opened only after they were
irreversibly assigned to the participants. The safekeeping of the
envelopes and the assignment of participants to each arm of
the trial (implementation of the random allocation sequence)
was overseen by a person not involved in the research study
and independent of the enrollment personnel. The participants’
treatment allocation was blinded to the research assistants
who conducted the intake interview, initial assessment, and
enrollment and for the independent assessors who conducted the
follow-up assessments. Participants were instructed not to reveal
their treatment allocation to those conducting the assessments.
  

Figure 1. Flow Diagram
005
Cancer erapy & Oncology International Journal
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
Enrollment, Assessments Times, Blind Data Collection,

Treatment group (TG) and control group (CG) participants
completed the instruments in person and on an individual
basis during distinct assessment moments. During Time 1,
research assistants formally trained in all of the instruments’
administration, who were not blind to the study but blind to the
participant’s treatment allocation, conducted the intake interview,
collected demographic data (e.g., name, age, gender, and contact
information), assessed potential participants for eligibility based
on the inclusion/exclusion criteria, obtained signed informed
consent from the participants, conducted the pre-treatment
application of instruments, enrolled participants in the study,
and randomly assigned each treatment group participant to one
of the treatment providers formally trained in the ASSYST-I that
participated in this study. The research assistants (all EMDR
therapy trained clinicians) also assisted the participants in
identifying their worst cancer-related adverse experience to be

written down by the research assistants on the Memory Record
Sheets that were utilized by the treatment providers during the
ASSYST-I treatment intervention and utilized by participants
during the three assessments times to ensure participants were
focusing on the same cancer-related adverse experience when

assessment time when they completed the assessment tools.
To obtain maximally interpretable PCL-5 and HADS scores,
research assistants and independent assessors:
a. Discussed with each participant the purpose of the
instruments in detail.
b. 
c. Invited participants to read each question carefully
before responding and select the correct answer.
d. 
e. Reworded conceptually complex symptoms when
necessary.
f. Reminded participants of last week’s symptoms’ time
frame, as well as.
g. To only report symptoms related to the pathogenic
memory of their worst adverse experience and not based on their
everyday general distress.
During Time 2 (post-treatment assessment seven days after
treatment) and Time 3 (follow-up assessment 30 days after
treatment), assessments were conducted for all participants
by blind-to-treatment allocation independent assessors with
formal training in the administration of the instruments. The
data safekeeper independent assessor received the participants’
assessment instruments that were answered during Times
1, 2, and 3. All data was collected, stored, and handled in full
compliance with the EMDR Mexico International Research Ethics

participant consented to access their data, which was strictly
required for study quality control. All procedures for handling,
storing, destroying, and processing data followed the Data
Protection Act 2018. All persons involved in this research project

Withdrawal from the Study and Missing Data
All research participants had the right to withdraw from the

prejudicial result. If participants decided to withdraw from the
study, they were no longer followed up in the research protocol.
There were no withdrawals or missing data during this study.
Treatment
Treatment Providers and Treatment Fidelity
The ASSYST-I was provided in person to each participant
by 12 licensed thanatologists formally trained in this treatment
intervention. Treatment providers received ongoing supervision
and clinical feedback from the research project Clinical Director
(MN) through daily online group supervision and completing
detailed session summary forms for each session with each

for the ASSYST-I treatment intervention to guide, elicit, monitor,

Treatment Description and Treatment Safety
A symptom trajectory-based stepped-care approach to
adverse experiences was used during this study. This means
a stepped progression of mental health care provided in an

symptom trajectory during the study. The main objectives of this
approach are:
a. To strategize treatment
b. To provide treatment interventions according to the
progression of pathophysiology
c. To improve symptom relief and clinical outcomes.
The participants’ treated pathogenic memories were an
average of 2.09 years old and received six in-person sessions,
averaging 49 minutes per session. The ASSYST-I treatment
intervention started with the worst pathogenic memory produced
by the cancer-related worst adverse experience (e.g., surgery for
the extirpation of affected organs, chemotherapy side effects)
selected during the T1. Pre-treatment assessment. Therefore, at

asked to run a mental movie of the previously selected cancer-
related worst adverse experience and then choose the worst part
(this pathogenic memory was like a still photo, not a movie).
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
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Cancer erapy & Oncology International Journal
Once the worst pathogenic memory reached subjective levels of
disturbance of zero or one (ecological/realistic), the patients were
instructed to run the mental movie again and select any other
disturbing part. This procedure was repeated until the entire
adverse experience could be visualized without highly distressing
parts. The treatment intervention was considered complete when
the participant’s subjective levels of disturbance associated with
all the worst adverse experience disturbing parts decreased
to zero or one (ecological/realistic). The ASSYST treatment
intervention was provided to all the treatment group participants
in an intensive treatment modality with two 60-minute
(max) sessions provided per day over three consecutive days.
   
events, or symptoms worsening. Therefore, participants were
instructed by their treatment providers to immediately report
any adverse effects (e.g., dissociative symptoms [derealization/
depersonalization], fear, panic, freeze, shut down, collapse,
fainting); events (e.g., suicidal ideation, suicide attempts, self-
harm, homicidal ideation); or symptoms worsening during the
entire study time frame. The TG participants reported no adverse
effects or events during the treatment procedure administration
or at the thirty-day follow-up. None of the participants in the
     
symptoms on the PCL-5 after completion of treatment.
Examples of the Pathogenic Memories Treated with the
ASSYST-I
Examples of pathogenic memories treated during the ASSYST-I
sessions were:
a. Looking at herself in front of a mirror with scars instead
of breasts.
b. Watching her hair fall out in uncontrolled clumps while
taking a shower.
c. Imagining her children homeless living on the street
because she died and there is no one to take care of them.
d. 
e. 
f.     
been removed.
Statistical Analyses
Analyses of variance (ANOVA) for repeated measurements
comparing two groups: treatment group (TG) vs control group
(CG) was applied to analyze the effects of the treatment across time
at three-time measurements: Time 1. Pre-treatment assessment,
       
assessment to analyze the effect of the treatment intervention
ASSYST-I on: PTSD, Anxiety, and Depression; eta squared () is
reported to show the effect size. Comparison of means analyses
were carried out using t test for independent samples and t test
within groups. Cohen´s d is included to report effect size for t test
results.
PTSD


  

interaction with a large effect size between time and group,
        = .738). Comparison of means
 
Pre-treatment assessment (M = 39.66, SD = 8.45 vs M = 38.86,
   
differences between the treatment group (TG) and control group
(CG) were found, with a medium effect, t (28) = - 7.481, p=.000,

      
treatment group (TG) and control group (CG) were also found,
with larger effect, t (28) = - 8.876, p=.000, d = - 2.31, (M = 14.26,
SD = 6.78 vs M = 41.86, SD=9.94). Intragroup comparisons of
      
between Time 1. Pre-treatment assessment and Time 2. Post-
treatment assessment with a large effect, t (14) = 9.73, p=.00, d =
2.17 and between Time 2. Post-treatment assessment and Time 3.
 
   
differences between Time 1 and Time 2, t (14) = -2.69, p =.01, d =

Table 1: Mean scores (M) and standard deviations (SD) at Time 1.
Pre-treatment assessment, Time 2. Post-treatment assessment, and
Time 3. Follow-up assessment by TG = Treatment Group, CG = Control
Group, *Statistically signicant di󰀨erences between groups.
Time 1 Time 2 Time 3
MSD M SD M SD
PTSD
TG 39.66 8.45 15.40* 7.29 14.26* 6.78
CG 39.86 11.57 40.93* 11.02 41.86* 9.94
Anxiety
TG 10.06 3.39 7.13* 4.35 5.80* 3.68
CG 10.2 4.05 10.93* 4.02 12.26* 3.75
Depression
TG 7.60 4.11 5.00* 4.03 4.06* 3.19
CG 7.53 3.22 8.66* 3.67 9.00* 3.07
Anxiety
Repeated-measures ANOVA determined that mean scores
        
(2,56) = 3.16, p= .05,  
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Cancer erapy & Oncology International Journal
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
  
           
= .415). Comparison of means between groups did not show
      
 

group (TG) and control group (CG) group were found, with a
medium effect, t (28) = - 2.40, p =.01, d = -.64, (M = 7.13, SD = 4.35

with a large effect, t (28) d = - 4.76, p =.000, d = - 1.22, (M =
5.80, SD = 3.68 vs M = 12.26, SD = 3.75). Intragroup comparison
        
differences between Time 1. Pre-treatment assessment and Time
2. Post-treatment assessment, with a medium effect, t (14) = 2.51,
    
           
.18. Intragroup comparison of means for the control group (CG)
      


Figure 2: PTSD mean scores with standard error across time by group.
Figure 3: Anxiety means scores with standard error across time by group.
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
008
Cancer erapy & Oncology International Journal
Figure 4: Depression means scores with standard error across time by group.
Depression
ANOVA for repeated measurements revealed that that mean

       
  =. 317). Inter-subject comparisons
          
   =. 175. Comparison of means between groups
        
Time 1. Pre-treatment assessment, (M= 7.60, SD= 4.11 vs M= 7.53,
       
differences between the treatment group (TG) and the control
group (CG) group were found, t (28) = - 2.60 p =.01, d = -0.64,

      
group (TG) and the control group (CG) group were found, t (28)
= - 43.12 p =.000, d = - 1.23, (M = 4.06, SD = 3.19 vs M = 9.00,
SD = 3.07). Intragroup comparison of means for the treatment
  
treatment assessment and Time 2. Post-treatment assessment, t
  
         
p=.005, d = .16. Intragroup comparison of means for the control
  


Discussion
The aim of this randomized controlled trial with an intention-

safety of the ASSYST-I treatment intervention in reducing PTSD,
anxiety, and depression symptoms in adult females with breast or
cervical cancer. A total of 30 adult females met the inclusion criteria
and participated in the study. Participants’ ages ranged from 37
to 62 years old (M =48.63 years old). A two-arm randomized
controlled trial (RCT) design was applied. This research design
was useful in demonstrating the effect of the ASSYST-I treatment
intervention in reducing PTSD, anxiety, and depression symptoms.
        
       
large and maintained effect in the treatment group at follow-
up. Results showed that the ASSYST-I treatment intervention
   
through ANOVA for repeated measurements. The stronger effect
         
dependent variables: PTSD, anxiety and depression. Regarding
the Reliable Change Index (RCI), all TG participants exhibited
reliable change in symptom reduction, with an average of 25.40
points for PTSD symptom reduction, 18 points being the more
conservative value. This is indicative that the ASSYST-I treatment
intervention reduced PTSD symptom severity beyond what is
attributable to measurement error. In reference to the Clinically
       

more likely to belong to the non-PTSD population.
Conclusion
Given the ubiquity of PTSD symptoms among women who
have experienced a cancer diagnosis, especially breast cancer,
one would determine that there would be a multitude of studies
demonstrating effective treatment intervention procedures
      
amount of literature provides evidence for the correlation between
009
Cancer erapy & Oncology International Journal
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
PTSD symptoms and breast cancer, and to some extent, cervical
         
in evidence-based research studies on treatment intervention
procedures to target cancer-related intrusion symptoms. The
    
present literature lacking in terms of actual treatment of cancer-
related PTSD symptoms.
The ASSYST-I treatment intervention goes beyond palliative
management of psychological distress in cancer-related PTSD
symptoms, and what is of particular importance to cancer-
related PTSD intrusion symptoms is that the ASSYST treatment
      
symptoms. Also, this treatment intervention includes in the
assessment phase the instruction, “or even looking into the
         
which is unique to and prominent among cancer patients. The
 
in the younger population, who may fear the cancer will return
later in life, or those with children, who fear what will happen to
their children if the cancer returns. This allows processing the

the cancer recurrence, even after treatment has been terminated.
This emphasizes the appropriateness of the ASSYST-Individual
as a cancer-related PTSD symptoms treatment intervention.
  
the ASSYST-I as an appropriate cancer-related PTSD, anxiety, and
depression symptoms treatment intervention for female breast or
cervical cancer patients. Due to the evidence of PTSD intrusion
symptoms as the dominant symptom cluster negatively impacting
female breast cancer patients, this is of vital importance for the
holistic treatment of female breast cancer and cervical cancer
patients.
Limitations and Future Directions
The small sample size and the follow-up assessment at 30 days
due to ethical reasons (providing treatment to the CG participants
as soon as possible) are limitations of this study. We recommend
future multicenter randomized controlled trials with an intention-
to-treat analysis, a larger sample, follow-up assessment at six
months, and following the Consolidated Standards of Reporting
Trials (CONSORT) 2010 Statement and the Standard Protocol
Items Recommendation for Interventional Trials (SPIRIT) 2013
checklist.
Conict of Interest and Funding
The authors declare that the research was conducted in the


Acknowledgment
We want to express our gratitude to the research assistants
and treatment providers who participated in this study: Amalia
Osorio Vigil, Isabel Guadalupe Rodríguez Salazar, Pilar Osorio
Vigil, Malena Abraham Gutié  ández López,
Alejandra Goytia Vázquez de Mercado, Liliana Ramos Martínez,
Tere Gómez Cortés, Valeria Sandoval Centeno, María de Lourdes
Guadalupe Lavalle, Leonor Elena Careaga Sartorius, María
Amparo Alonso Soberón, Marí
Vera Tlachés, Claudia Montserrat Denetro García, Argelia Vázquez
Garcí   óngora, María Abiti Maldonado, Jenny
Hidalgo Ramé, Jessica Vasconcelos Beltráérez Gómez,
Alma Rosa Martínez Chávez.
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on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
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0011
Cancer erapy & Oncology International Journal
How to cite this article: Ross J, Navarro F, Mainthow N, Givaudan M, Jarero I. Breast And Cervical Cancer-Related PTSD: Randomized Controlled Trial
on the ASSYST Treatment Intervention . Canc Therapy & Oncol Int J. 2024; 25(5): 556175. DOI: 10.19080/CTOIJ.2024.25.556175
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DOI: 10.19080/CTOIJ.2024.25.556175
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49. Ying Lin C, Pakpour AH (2017) Using Hospital Anxiety and Depression
  
and Rasch models. Seizure 45: 42-46.
... This intervention is specifically designed to provide in-person or online support to clients who present PTSD or ASD, intense psychological distress, or physiological reactivity caused by the disorders' intrusion symptoms associated with the memories of the traumatic event(s) or adverse experience(s). It has been used in at least nine studies, totaling 392 participants Carretero et al., 2023;Mainthow et al., 2022Mainthow et al., , 2023Magalhães et al., 2022Magalhães et al., , 2023Ross et al., 2024;Smith et al., 2023;Smyth-Dent et al., 2021). Ehlers et al. (2004, p. 403) suggested that triggers or cues of reexperiencing (intrusion) symptoms in individuals with PTSD are usually sensory impressions and emotional responses from the trauma that appear to lack a time perspective and a context. ...
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Clients with obsessive-compulsive disorder (OCD) symptoms pose a challenge for psychotherapists. Current evidence-based treatments have limitations in efficacy and client retention. This article reports on 17 cases treated with the Acute Stress Syndrome Stabilization Individual (ASSYST-I) Adapted for OCD in an outpatient mental health clinic in Uruguay. The average number of sessions was 16. Clients completed the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to assess OCD symptom severity before and after treatment. Wilcoxon signed-rank tests found significant differences between pre- and posttreatment on the Y-BOCS total scores ( z = −3.624, p < .001), obsessions subtotal scores ( z = −3.627, p < .001), and compulsions subtotal scores ( z = −3.624, p < .001). This study describes the ASSYST-I Adapted for OCD and discusses its preliminary safety, feasibility, and acceptability.
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The aim of this randomized controlled trial with an intention-to-treat analysis was to evaluate the effectiveness, efficacy, and safety of the Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in female children polytraumatized by adverse childhood experiences, neglect, and maltreatment. A total of 40 female children met the inclusion criteria and participated in the study. Participants’ ages ranged from 8 to 17 years old (M =14.67 years). A two-arm randomized controlled trial (RCT) design was applied. PTSD symptoms were measured in three-time points for all participants in the study. Results showed that the intervention had a significant effect for time on PTSD symptoms (F (2,76) = 36.92 p <.000, η² = .493). A significant effect for group was also found (F (1, 38 = 32.7, p<.005, η² = .896) with a large effect, and a significant interaction between time and group, (F (2, 76) = 56.00, p <.000, η² = .600). Means comparison using t test between groups showed significant differences between the Treatment Group (TG) and the Control Group (CG) in the three-time points comparisons showing a large effect on Time 2 (Post-treatment assessment) which was maintained on Time 3 (Follow-up assessment). Results on the Reliable Change Index (RCI) and the Clinically Significant Change (CSC) Margin showed that the ASSYST-I treatment intervention exhibited reliable change on PTSD symptom reduction and clinically significant change, indicating that the treatment group participants are more likely to belong to the non-PTSD population after the intervention. Conversely, the control group participants are more likely to belong to the PTSD population. No adverse effects or events were reported by the participants during the treatment procedure administration or at follow-up. None of the participants showed clinically significant worsening/exacerbation of symptoms after treatment. Participants in the control group received the intervention treatment after the follow-up assessment, fulfilling our ethical criteria.
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The aim of this randomized clinical controlled trial and humanitarian psychosocial assistance project was to evaluate the effectiveness of the Acute Stress Syndrome Stabilization Individual Remote (ASSYST-IR) treatment intervention in reducing posttraumatic stress disorder (PTSD), depression, and anxiety symptoms of sixty-one public sector workers during the COVID-19 pandemic. A two-arm randomized controlled trial (RCT) design was applied. PTSD, anxiety, and depression symptoms were measured in three-time points for all participants in the study. The statistical analyses showed a significant decrease in PTSD, anxiety, and depression symptoms in the treatment group participants, while the control group participants maintained or increased anxiety and depression symptoms, with a discrete improvement in the level of PTSD symptoms. The statistical results and clinical observations confirmed the effectiveness, efficiency, and safety of the ASSYST-IR in the mental health recovery of the treatment group participants, possibly preventing the development of PTSD and contributing to the collective health of the participants and people in their work and social environment.
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The statistical analysis and the clinical reports confirmed that the ASSYST-I is an effective, safe, and efficient treatment intervention to reduce PTSD, anxiety, and depression symptoms caused by pathogenic memories produced by adverse childhood experiences in the adult female general population. No adverse effects or events were reported by the participants during the treatment procedure administration or at sixty-day follow-up. None of the participants showed clinically significant worsening/exacerbation of symptoms after treatment. All participants received the intervention treatment according to the research design, fulfilling our ethical criteria.
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The emergence of cases of COVID-19 led to the emergence of acute stress in the general population, especially in health professionals and, among them, in mental health, who began to have a high demand for care for people suffering from disorders. related to trauma and stressors as a result of: social isolation, hospitalization, deaths, worsening of the financial situation with loss of job, among others. Objective: this work with the Protocol for the Stabilization of Acute Remote Stress Syndrome in Group Format aims to provide the first psychological care to reduce disturbances and improve adaptive functioning, avoiding the evolution to more dysfunctional psychological conditions such as Post Stress Disorder -Traumatic (PTSD). Methodology: twentythree (23) participants (psychologists) were selected and all responded to psychometric assessment scales (HADS and PCL-5) before and after 2 (two) online therapy sessions (videoconference) with application of the protocol. Results: the regression model shows a mean reduction in the anxiety score of -2.3 (ep 0.9), with p-value = 0.0010; significant; in the depression score, mean of 1.13 (p=0.125); and in the PTSD score, a mean reduction of –9.5 (3.3), with p-value=0.006. Discussion: the statistical Results revealed an approximation with the Results of the research carried out by Becker et al (2021). According to these authors, no adverse effects were reported by the participants during the intervention, confirming the efficacy, feasibility and safety of ASSYST-RG. Conclusion: The results show that ASSYST-RG was effective in reducing anxiety, depression and PTSD.
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This multisite clinical trial had two objectives: 1) to evaluate the effectiveness, efficacy, and safety of the Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD), depression, and anxiety symptoms in the adult general population with pathogenic memories over three months old, and 2) to explore the correlation coefficient between the PCL-5 total 20 items score and the PCL-5 PTSD Cluster B five intrusion symptoms score with the Anxiety and Depression variables. A total of 43 adults (39 females and 4 males) met the inclusion criteria and participated in the study. Participants' ages ranged from 20 to 78 years old (M =47.34 years). Repeated-measures ANOVA were carried out to observe the effect of the intervention on the variables across three time points (Time 1 Pre-treatment, Time 2 Post-treatment, and Time 3 Follow-up). Results showed significant effects of the ASSYST-I on PTSD, intrusion, anxiety, and depression symptoms. Findings provide evidence of the effectiveness, efficacy, and safety of the ASSYST-I in reducing posttraumatic stress, anxiety, and depression symptoms in the general adult population with non-recent pathogenic memories.
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We calculated the reliable change index (RCI) and clinically significant change (CSC) values for two widely used measures of posttraumatic stress disorder (PTSD): The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5) and examined how symptom changes at these thresholds related to improvements in psychosocial functioning. We used data from three independent samples of male military veterans, including two randomized controlled trials for PTSD (N = 198 for Sample 1 and N = 102 for Sample 2) and a cross-sectional study of primary care patients (N = 228). For Sample 1, within-person change in CAPS-5 and PCL-5 scores of ≥ 13 and 15, respectively, was indicative of reliable change. For Sample 2, within-person change in CAPS-5 and PCL-5 scores of ≥ 12 and 18, respectively, was indicative of reliable change. Scores of ≤ 8 and 28 on the CAPS-5 and PCL-5, respectively, indicated a participant is more likely to belong to the non-PTSD population than the PTSD population (i.e., clinically significant change) in both Samples 1 and 2. Participants who exhibited reliable or CSC reported significantly better psychosocial functioning at all posttreatment assessments than those who did not. Results provide thresholds for identifying clinically meaningful PTSD symptom change using these measures. Care should be taken to interpret these values appropriately and relative to numerous other definitions for meaningful symptom change. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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Translational research highlights the potential of novel 'memory consolidation/reconsolidation therapies' to treat re-experiencing symptoms and post-traumatic stress disorder (PTSD). This systematic review and meta-analysis assessed the efficacy of so-called memory consolidation/reconsolidation therapies in randomised controlled trials (RCTs) for prevention and treatment of PTSD and symptoms of re-experiencing in children and adults (PROSPERO: CRD42020171167). RCTs were identified and rated for risk of bias. Available data was pooled to calculate risk ratios (RR) for PTSD prevalence and standardised mean differences (SMD) for PTSD/re-experiencing severity. Twenty-five RCTs met inclusion criteria (16 prevention and nine treatment trials). The methodology of most studies had a significant risk of bias. We found a large effect of reconsolidation interventions in the treatment of PTSD (11 studies, n = 372, SMD: −1.42 (−2.25 to −0.58), and a smaller positive effect of consolidation interventions in the prevention of PTSD (12 studies, n = 2821, RR: 0.67 (0.50 to 0.90). Only three protocols (hydrocortisone for PTSD prevention, Reconsolidation of Traumatic Memories (RTM) for treatment of PTSD symptoms and cognitive task memory interference procedure with memory reactivation (MR) for intrusive memories) were superior to control. There is some emerging evidence of consolidation and reconsolidation therapies in the prevention and treatment of PTSD and intrusive memories specifically. Translational research should strictly adhere to protocols/procedures describing precise reconsolidation conditions (e.g. MR) to both increase the likelihood of positive findings and more confidently interpret negative findings of putative reconsolidation agents.
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The aim objective of this field trial was to evaluate the feasibility and effectiveness of the Acute Stress Syndrome Stabilization Remote Individual (ASSYST-RI) procedure in decreasing the levels of subjective perceived disturbance produced by the psychological distress or physiological reactivity of recent adverse experiences (e.g., kidnappings, COVID-19-related distress, interpersonal violence). A total of 48 participants (39 females and 9 males) ranging in ages from 18 to 67 years old (M=37.1 years) received one-single ASSYST-RI session of 50 minutes average duration. Participation was voluntary with the participants’ verbal informed consent in accordance with the Mental Capacity Act 2005. The telemental health counseling was in compliance with the American Psychological Association (APA) Guidelines for the Practice of Telepsychology. A pre-post design was applied comparing the subjective units of disturbance (SUD) means using a within t-test analysis. Results showed significant differences with a large effect size. Pre-test (M = 8.27, SD = 1.69) and post-test (M = 1.45, SD = 1.66), Cohen’s d =3.32. This field trial provides preliminary evidence on the ASSYST-RI feasibility and effectiveness in decreasing the levels of subjective perceived disturbance produced by the psychological distress or physiological reactivity of recent adverse experiences.
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The aim of this longitudinal multisite randomized controlled trial (RCT), using a treatment as usual (TAU) control group design, was to evaluate the effectiveness of the Acute Stress Syndrome Stabilization Remote for Groups (ASSYST-RG) procedure in reducing posttraumatic stress disorder (PTSD), depression, and anxiety symptoms in the general population during the COVID-19 pandemic lockdown in Mexico. A total of 63 adults (60 females and 3 males) met the inclusion criteria. Participants’ ages ranged from 21 to 73 years old (M =43.09 years). Significant differences between groups were found in all variables. Differences between groups were maintained at follow up assessment. ANOVA for repeated-measures (pre-treatment, post-treatment and follow-up) showed that the ASSYST-RG had a significant effect to reduce Posttraumatic Stress Disorder (F (2, 122) = 22.40 p <.000, ηP2 = .269). Anxiety and depression showed a significant interaction effect for time and group (F (1, 61) = 8.89, p <.00, ηP2= .127) and (F (2, 122) = 35.04, p <.001, ηP2 = .365) respectively. No adverse effects or events were reported by the participants during the procedure administration or at three months follow-up while all participants were still in lockdown. None of the participants showed clinically significant worsening/exacerbation of symptoms after the procedure. This randomized controlled trial provides evidence for the effectiveness, efficacy, feasibility, and safety of the ASSYST-RG in reducing posttraumatic stress, anxiety, and depression symptoms in the general population during the COVID-19 pandemic lockdown.
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The present study was carried out to investigate the efficacy of eye movement desensitization and reprocessing (EMDR) therapy in treating pain and subjective distress of patients with cancer. A randomized controlled trial was performed on patients with cancer suffering from moderate to severe cancer pain in Yasuj, Iran, in 2019 and 2020. Sixty patients aged 30–60 years who fulfilled the inclusion criteria were selected using a consensus sampling technique. Patients were randomly assigned to EMDR therapy or control groups based on random block allocation. EMDR therapy was administered in six to eight daily 1-hour sessions. The control group received the standard treatment provided by the hospital. A Numeric Pain-Rating Scale (NRS) and the Subjective Units of Disturbance Scale (SUDS) were used to assess pain and subjective distress before and after the intervention in each session. The collected data were analyzed by descriptive statistics, chi-square test, and independent t test using Statistical Package for the Social Sciences (SPSS) version 24. The mean pain intensity and subjective distress score in the experimental group before and after the EMDR intervention were significantly reduced ( p < .001). In the control group, no decreases in NRS and SUDS scores occurred at any time ( p > .05). Differences in pain scores between the groups were statistically significant ( p < .001). EMDR can effectively and sustainably reduce the pain and subjective distress experienced by patients with cancer. Thus, EMDR is a recommended therapeutic option to mitigate pain and subjective distress among patients with cancer.