RECRUITING

Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

Quick Facts

Study Start:2021-12-08
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05274230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or over
  2. * Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort)
  3. * completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort)
  4. * enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out
  1. * Unable to give adequate informed consent
  2. * Have any current problem which, in the opinion of the investigator might interfere with participation
  3. * Are unable to complete questionnaires written in English

Contacts and Locations

Study Contact

Nicole Grinsell, MS
CONTACT
8559220057
nicole@apolloneuro.com
Mahender Mandala, PhD
CONTACT
mahi@apolloneuro.com

Principal Investigator

Belinda Tan, MD PhD
PRINCIPAL_INVESTIGATOR
The Board of Medicine

Study Locations (Sites)

Apollo Neuroscience, Inc.
Pittsburgh, Pennsylvania, 15219
United States

Collaborators and Investigators

Sponsor: Apollo Neuroscience, Inc.

  • Belinda Tan, MD PhD, PRINCIPAL_INVESTIGATOR, The Board of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-08
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-12-08
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • remission
  • PTSD
  • psychotherapy
  • MDMA

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic