Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
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
Condition or Disease
- Stress Disorders, Post-Traumatic
Phase
Study Design
| Study type: | Interventional |
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| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 200 () |
| Funded by: | Industry|Other |
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Clinical Trial Dates
| Start date: | Dec 08, 2021 | |
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| Primary Completion: | Dec 31, 2024 | |
| Completion Date: | Dec 31, 2025 | |
| Study First Posted: | Mar 10, 2022 | |
| Last Updated: | May 02, 2022 |
Sponsors / Collaborators
Location
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.
Eligibility Criteria
| Sex: | All |
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This clinical trial is recruiting
Are you interested in participating in this trial or others? We'd love to help.
More Details
| NCT Number: | NCT05274230 |
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| Other IDs: | AN006|20214600 |
| Study URL: | https://ClinicalTrials.gov/show/NCT05274230 |