Loading study record…
This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-19
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
This treatment combines MDMA with a well researched treatment for PTSD for dyads known as CBCT. Dyads will undergo a 7-week course of psychotherapy with two doses of MDMA will be used as an adjunct to psychotherapy.
MDMA-assisted CBCTA manualized treatment for PTSD for dyads wherein one person has symptoms of PTSD. This intervention is 7-week course of psychotherapy that is designed to simultaneously improve PTSD symptoms and relationship functioning through education and skill training.
CBCTEligibility
primary outcomes
Time frame: 3-Month Follow-up
The Feasibility of Intervention Measure (FIM) is a self-report questionnaire in which respondents indicate the extent to which they believe that the treatment can be delivered in a given setting. Respondents indicate their responses on a five-point Likert-type (1=completely disagree, 5= completely agree).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
Safety will be assessed by examining the frequency and severity of adverse events (AEs), serious AEs (SAEs), treatment emergent AES (TEAEs), and AEs of special interest. Participants are asked to report any AEs, SAEs, TEAEs, and AEs of special interest as they happen and during any communication with the therapist or independent assessor.
Time frame: 3-month follow-up
Intervention Appropriateness Measures (IAM) is a self-report measure of the perceived fit, relevance, or compatibility of an intervention. Respondents record their answers on a five-point Likert-type scale (1=completely disagree, 5= completely agree).
Time frame: 3-Month Follow-up
The Long Term Follow-Up Questionnaire (LTFUQ) is a self-report measure that assesses the long-term benefits and harms of MDMA-assisted therapy.
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
secondary outcomes
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
PTSD Checklist for the DSM-5 (PCL-5) is a self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the DSM-5 symptoms of PTSD. Participants indicate how much distress they have experienced due to symptoms on a five-point Likert-type scale (1 = not at all, 5 = extremely). The total PCL-5 score (a sum of all 20 items) provides an index of overall PTSD symptom severity with higher scores indicating higher severity.
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Quality of Relationships Inventory (QRI) is a self-report questionnaire that uses the role of situational, intrapersonal, and interpersonal in social support processes to assess supportive and conflictual aspects of close non-intimate relationships.
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Couple Satisfaction Index (CSI) is a self-report questionnaire that measures intimate relationship functioning. Respondents answer most of the questions on a six-point Likert-type scale (0= never, 5= all the time) and one question on a seven-point Likert-type scale ( 0= extremely unhappy, 6= perfect).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Patient Health Questionnaire-9 (PHQ-9) is used to assess depressive symptom severity. The PHQ-9 includes items which correspond with the diagnostic criteria for DSM-IV major depressive disorder. Scores can indicate either no depression, minimal, mild, moderate, moderately severe, or severe depression. Higher scores indicate higher severity in depressive symptoms.
other outcomes
Time frame: Baseline (enrolment) to Follow-up (3 month follow-up)
The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life.
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Self-Compassion Scale-Short Form (SCS-SF) is a 12-item self-report measures that assess self-compassion. This measure is comprised of the following subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identification. Respondents answer questions on a five-point Likert-type scale (1= almost never, 5= almost always).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item self-report measure that assesses experiential avoidance. Respondents rate the extent to which they agree with each item on a six-point Likert-type scale (1 = strongly disagree, 6= strongly agree).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test-Revised (CUDIT-R), and Drug Use Disorders Identification Test (DUDIT) are self-report questionnaires that assess alcohol and substance use.
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Brief Posttraumatic Cognitions Inventory (PTCI-9) is a nine-item self-report questionnaire that measures appraisals related to trauma. Respondents answer the questionnaire on a seven-point Likert-type scale (1= totally disagree, 7= totally agree).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The MOS Social Support Survey (MOS-SSS) is a 20-item multidimensional self-report questionnaire that assess perceived availability of social support. Respondents answer questions on a seven-point Likert-type scale (1 = none of the time, 7= all of the time), where higher score indicate greater levels of available social support.
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Significant Others' Responses to Trauma Scale (SORTS) is a 14-item self-report questionnaire that measures relationship problems and the psychological distress of partners of people with PTSD. Respondents answer questions on a five-point Likert scale (0-4).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Modified Experiences in Close Relationships (ECR-M16) is a 16-item self-report questionnaire that assesses attachment style. Half of the items on the scale measure attachment anxiety and the other half measures attachment avoidance. Respondents answer questions on a seven-point Likert-type scale (1= disagree, 7=agree).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Psychological Insights Questionnaire (PIQ) is a a 23-item self-report measure that assesses acute experiences of insight (i.e., beliefs, memories, emotions, etc.). Respondents answer questions on a six-point Likert-type scale (0= no, not at all; 5= extremely).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Mystical Experiences Questionnaire (MEQ30) is a 30-item self-report questionnaire that assesses discrete mystical experiences. Respondents rate the extent to which the experience mystical feeling, positive mood, transcendence of space/time, and ineffability on a five-point Likert-type scale (0= no/not at all, 4= extreme).
Time frame: Baseline (enrolment) to Follow-up (3-month follow-up)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered measure of suicidal behaviour devised to detect potential suicidal thoughts or behaviours. It is designed to assess suicidal ideation, ideation intensity, and behaviour.
Time frame: Baseline (enrolment)
The Credibility Expectancy Questionnaire (CEQ) is a six-item self-report measure of beliefs about treatment credibility and expectancy of treatment outcomes. The some questions on the questionnaire are answered on a scale ranging from 1 (not at all) to 9 (very much) and that others are answered on a scale ranging from 0 (not at all) to 100% (very much).
Time frame: First therapy session, Mid-point, and Follow-up (3-month follow-up)
The Working Alliance Inventory-Observer Form (WAI-O) is a 36-item observer-rated measure of the alliance between a therapist and client. Observers rate each item on a scale from 1 (Never applies to the dyad) to 7 (Always applies to the dyad).
Publications
No exact PMID-linked public article is currently readable locally.