Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- Apollo Neuroscience, Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- PTSD Checklist for DSM-5 (PCL-5)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation.
This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years
Detailed Description
The study examines the effect of the Apollo wearable on its users after undergoing MDMA-assisted psychotherapy. There will be no study specific modification to the MDMA-assisted psychotherapy that participants receive. All study participants will have previously consented to MAPS MDMA-assisted psychotherapy for PTSD clinical trial before enrolling in this protocol. Once they have been identified as people who have been consented to the MAPS trial regardless of this research, they will be approached about the study, and screened/consented/enrolled accordingly. Participants will receive the Apollo wearable device via mail upon consenting to participate in this study. They will be provided an instruction manual with guidelines on how to best use the device and will be asked to continue to use the Apollo device in their everyday life following MDMA-assisted psychotherapy. Participants in the study will be asked to complete monthly online questionnaires for the duration of the two year study. Please note: this study is not affiliated with the MAPS organization who is running the MDMA-assisted psychotherapy research study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 or over
- •Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort)
- •completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort)
- •enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out
Exclusion Criteria
- •Unable to give adequate informed consent
- •Have any current problem which, in the opinion of the investigator might interfere with participation
- •Are unable to complete questionnaires written in English
Outcomes
Primary Outcomes
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Through study completion, an average of two years
PTSD Checklist for DSM-5 (PCL-5) will be used to measure symptoms of PTSD.
Beck Depression Inventory II (BDI-II)
Time Frame: Through study completion, an average of two years
Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression.
Secondary Outcomes
- Alcohol Use Disorders Identification Test (AUDIT)(Through study completion, an average of two years)
- World Health Organization Health and Work Performance Questionnaire (HPQ Short form)(Through study completion, an average of two years)
- Drug Use Disorders Identification Test (DUDIT)(Through study completion, an average of two years)
- Chronic Pain Grade Scale (CPGS)(Through study completion, an average of two years)