Stress Disorders, Post-Traumatic
Conditions
Keywords
remission, PTSD, psychotherapy, MDMA
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.
Interventions
DEVICEApollo Wearable
Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phone. Participants will use the Apollo for at least 30 minutes after waking up in the morning and at least 30 minutes before bed on the corresponding settings for those times of day. They will be given the Apollo Device TVS (10-200 Hz) to borrow which they will be instructed to wear everyday. They will be asked to continue to wear the device until all study data is collected.
Sponsors
The Board of Medicine
Apollo Neuroscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | 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) | Through study completion, an average of two years | Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Health and Work Performance Questionnaire (HPQ Short form) | Through study completion, an average of two years | World Health Organization Health and Work Performance Questionnaire (HPQ Short form) will be used to measure work performance. |
| Alcohol Use Disorders Identification Test (AUDIT) | Through study completion, an average of two years | Alcohol Use Disorders Identification Test (AUDIT) will be used to measure alcohol use. |
| Drug Use Disorders Identification Test (DUDIT) | Through study completion, an average of two years | Drug Use Disorders Identification Test (DUDIT) will be used to measure drug use |
| Chronic Pain Grade Scale (CPGS) | Through study completion, an average of two years | Chronic Pain Grade Scale (CPGS) will be used to provide a measure of symptoms of pain. The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. The 3 subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting. |
Countries
United States
Contacts
Primary ContactNicole Grinsell, MS
Backup ContactMahender Mandala, PhD
Outcome results
None listed