- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05895318
Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD (PMATAVP)
June 20, 2023 updated by: Albany Research Institute, Inc.
The goal of this exploratory, mixed-method design study is to gather qualitative and quantitative data obtained through interviews and questionnaires with veterans who are currently enrolled at the VA for healthcare.
The main question this study aims to answer is: How do veterans diagnosed with PTSD and enrolled for care at the VA understand MDMA-assisted therapy for PTSD?
Using a story-completion approach, participants will be provided with a brief story starter involving a fictitious character and scenario and asking them to complete the story.
Few contextual details will be offered about the character.
In responding to ambiguous cues, participants are thought to project their conscious and subconscious perceptions about the phenomenon in question onto the story, a useful method for exploring stigmatized topics.
The purpose of this exercise is to ascertain the participants attitudes and perceptions regarding MDMA-Assisted Therapy.
Study Overview
Status
Completed
Conditions
Detailed Description
Veterans will be informed of the study by their VA providers (Behavioral Health Clinic, PCMHI, PTSD Clinic, CDRP, Primary Care).
Veterans who are interested will have their contact information passed on to the study investigators.
Once screened and enrolled in the study veterans will complete a brief demographics form, and three brief symptom screening questionnaires: PTSD Checklist for DSM-5, 5-Item screener for PTSD, and Patient Health Questionnaire 9. Participants then engage in the recorded interview during which they are provided with a brief story starter, as described above.
In the story, a fictitious veteran with a diagnosis of PTSD is offered an opportunity to enroll in a clinical trial and receive MDMA-Assisted therapy.
Participants are asked to share what questions, concerns, hopes, and expectations may be present for the fictitious veteran in the story.
Interviews will then be transcribed and the PI and the collaborators will read all transcriptions and generate recurring themes that can be reliably coded.
The investigators will then code the transcripts for the presence of themes.
Data analytic plans include calculating the prevalence of each theme and examining their correlates with measures of severity of symptoms as well as any demographic variables.
It is hoped that this data can inform educational and other roll-out efforts within the VA system as MDMA-Assisted therapy approaches FDA approval as a treatment for PTSD.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Albany, New York, United States, 12208
- Stratton VA Medical Center
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The demographic makeup of the sample mimics the demographic makeup of the population of veterans served by VA.
As such, the racial distributions will likely be primarily Caucasian, the sample is likely to be predominantly male, ranging in age from 20-100, with an average of 58 years.
Description
Inclusion Criteria:
- Veterans enrolled in VA care
- Active diagnosis of PTSD, as determined by the referring provider or confirmed by medical records.
- Age 18 or older
- Fluent in written and spoken English
Exclusion Criteria:
- Cognitively impaired to the extent that patient cannot comprehend the survey
- Has already completed the interview
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire 9
Time Frame: 2 weeks
|
Screening tool for depressive symptoms.
Scores range from 0-27 with lower scores indicating better outcomes
|
2 weeks
|
PTSD Checklist for DSM5
Time Frame: 4 weeks
|
Screening tool for PTSD symptoms.
Scores range from 0-80 with lower scores indicating better outcomes
|
4 weeks
|
5 Item Screener for PTSD
Time Frame: 2 weeks
|
Screening tool for PTSD symptoms.
Scores range from 0-4 with lower scores indicating better outcomes.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caitlin Holley, Ph.D., Stratton VA Medical Center
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 Major Dates
Study Start (Actual)
August 8, 2022
Primary Completion (Actual)
March 23, 2023
Study Completion (Actual)
March 23, 2023
Study Registration Dates
First Submitted
May 31, 2023
First Submitted That Met QC Criteria
May 31, 2023
First Posted (Actual)
June 8, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 061006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Traumatic Stress Disorder
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University of California, Los AngelesRecruitingPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of ZurichCompletedPost Traumatic Stress Disorder (PTSD) | Complex Post-Traumatic Stress Disorder (CPTSD)Switzerland
-
University of NottinghamNottinghamshire Healthcare NHS Trust; Lincolnshire Partnership NHS Foundation...CompletedDomestic Violence | Trauma, Psychological | Post-Traumatic Stress Disorder in Children | Narrative Exposure Therapy | Post-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder ComplexUnited Kingdom
-
Erkin Oğuz SARINot yet recruitingPost-Traumatic Stress DisorderTurkey
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance