Trial · NCT06394284
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PTSD | Enrollment and visit 16, two weeks to one month after the final therapy session, approximately 4 months after first visit. | Clinician-Administered PTSD Scale-5 (CAPS-5) will be performed during the intake interview. The CAPS-5 is a structured clinical interview used to assess the presence of a PTSD diagnosis and PTSD symptom levels over the past month. |
| Primary | Oxytocin | At 4 time points during the 3 long sessions (visit 4, one month after enrollment, visit 8, two months after enrollment and visit 12, three months after enrollment) | As this study is designated as a mechanisms of change study, the primary outcome is that of exploring the role of oxytocin in the therapeutic process. The primary outcome measure is thus the hormone assessment of increased oxytocin (primary) as mediating the change in PTSD (and MI-exploratory) symptoms. Saliva collection will be the same for both MDMA-assisted and Somatic-based therapy groups and the collection relevant for the measurement of both oxytocin (primary) and cortisol (exploratory). Four saliva samples will be collected at four time points during each of the experimental (or intense) sessions: prior to commencing the session, +90 minutes +210, +320 minutes following the administration of MDMA or commencement of the Somatic-based arm. To assess oxytocin concentrations, saliva samples will be thawed and then dried using a SpeedVac concentrator. The evaporated samples are then reconstituted with an assay diluent. Oxytocin concentrations will be measured using an ELISA kit |
| Secondary | Hyperarrousal- EEG | EEG- during visits 3 (three weeks after enrollment), 7 (three weeks after the first long session) and visit 16 (two weeks to a month after the final therapy session) (pre, post 1st long session, post study) | Mismatch negativity task (MMN) is an event-related potential (ERP) task that examines a pre-attentive brain-response to changes in the acoustic environment (frequent standard tone versus infrequent odd tone).. MMN ERP amplitudes of early N1 components (recorded via scalp-EEG) represent early even-related time-locked difference-waveforms that result from subtracting the standard tone ERP's from the odd-sound ERP's and noting the peak difference in MMN amplitude peak-negativity i.e. MMN amplitudes) around 120 ms after tone-onset. A healthier response is when the infrequent odd sound (change in pitch) produces larger N1 amplitudes (under central prefrontal electrodes) at 100-150 ms post stimulus in comparison to the standard tone early N1 amplitudes, which indicates that automatic "sound-change-detection" registered at auditory and prefrontal cortical networks effectively. |
| Secondary | Hyperarrousal- cortisol | Cortisol, as outlined in oxytocin collection | Cortisol concentrations will be assessed using commercially available ELISA kits (Salimetrics, USA), following the manufacturer's instructions. All samples will be assessed in duplicate. |
| Secondary | Moral Injury | visit 1 and visit 16 (two weeks to a month after the final therapy session) (pre-post) | MIOS- Moral Injury Outcome Scale. Based on over a decades work in the field, a new measure has been designed with promising measurement capabilities though validation work in Israel is ongoing. The Moral Injury Outcome Scale (MIOS) measures shame-related and trust-violation-related outcomes and thus far has demonstrated good discriminative validity between those who have experienced potentially morally injurious events and those who haven't. A higher score indicates higher moral injury. |
| Secondary | Functional Impairment | Visits 1,7 (three weeks after first long session),11 (three weeks after second long session) and 16 (two weeks to a month after final therapy session) | The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely). Per FDA request, for participants who are not able to work for reasons related to PTSD, the functional impairment item will be scored as a 10. The SDS takes 1 to 2 minutes to complete. |
| Secondary | Self Compassion | Visits 1,7 (three weeks after first long session),11 (three weeks after second long session) and 16 (two weeks to a month after final therapy session) | The Self Compassion Scale (SCS) is a widely used and widely tested measure of self compassion. If consists of 26 questions measuring the six components of self-compassion: Self-Kindness, reduced Self-Judgment, Common Humanity, reduced Isolation, Mindfulness and reduced Overidentification. The SCS has been validated and factors analyzed with over 11,000 participants and is also in use in current MAPS sponsored studies allowing for data collaboration. Higher scores indicate higher self compassion. Total scores are normally used for research and mean scores for interpretation though there are no clinically validated means (mean scores of 1.0-2.49 are considered to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high). The questionnaire takes around 7 minutes to complete. |
| Secondary | Interoception | Visits 1,7 (three weeks after first long session),11 (three weeks after second long session) and 16 (two weeks to a month after final therapy session) | The Multidimensional Assessment of Interoceptive Awareness 2 (MAIA-2) is a 37 item measure of the ability to notice, be present, not worry, regulate attention to- and trust body experiences. Complementary to the DERS-16, the MAIA-2 focuses on body-related regulation and introspection. It has been used widely in research on mindfulness and compassion based therapies and demonstrated strong relationships to symptom relief and takes around 10 minutes to complete. |
| Secondary | Emotional Regulation | Visits 1,7 (three weeks after first long session),11 (three weeks after second long session) and 16 (two weeks to a month after final therapy session) | The Difficulties in Emotion Regulation Scale-16 question version (DERS-16) is a shortened version of the full Difficulties in Emotion Regulation Scale which is a 36-item self-report questionnaire that measures the extent to which individuals have difficulty responding to distressing emotions. Participants rate items on a 5-point Likert scale (1 = almost never to 5 = almost always) with responses (some reversed) giving a total score in addition to six subscale scores; Awareness, Clarity, Nonacceptance, Impulsivity, Goals, and Strategies. Subscales are scored such that higher scores indicate more difficulties. The shortened version retains the subscales and demonstrates good comparative validity and internal consistency. The subscales of awareness and non-acceptance will be used to assess increased connection to self. The questionnaire takes around 5 minutes to complete. |
| Secondary | Attachment | Visits 1,7 (three weeks after first long session),11 (three weeks after second long session) and 16 (two weeks to a month after final sessions. | Experience of Close Relationships (ECR) Scale is composed of two 18-item subscales measuring attachment anxiety and attachment avoidance, using a 7-point Likert Scale. Subscale scores are obtained by summing and computing the mean and demonstrate high reliability and validity. Scores on this measure will be used as predictive of treatment success with lower anxiety and avoidance predicted to be indicative of better treatment potential and also as a mediator variable of enhanced connection to others (reduction in attachment avoidance). The questionnaire takes around 7 minutes to complete and higher scores indicate higher anxiety or avoidance on subscales. |
| Secondary | Attachment | During the three long (visit 4, one month after enrollment, visit 8, two months after enrollment and visit 12, three months after enrollment) and three initial integration sessions (the morning after a long session). | In addition to overall attachment characteristics as measured by the ECR, attachment security may fluctuate based on situational factors, which relates to the influence of extrapharmacological factors on experiences with MDMA-AT (i.e., set and setting). To address this, the Security subscale of the State Adult Attachment Measure (SAAM) will be administered. Higher scores indicate higher security in attachment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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