PMATAVP: Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

Sponsor

Albany Research Institute, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT05895318

Collaborator

(none)

Enrollment

Location

7.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder

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. We 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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

Actual Study Start Date :

Aug 8, 2022

Actual Primary Completion Date :

Mar 23, 2023

Actual Study Completion Date :

Mar 23, 2023

Outcome Measures

Primary Outcome Measures

Patient Health Questionnaire 9 (PHQ-9) [2 weeks]
Screening tool for depressive symptoms
PTSD Checklist for DSM5 [4 weeks]
Screening tool for PTSD symptoms
5 Item Screener for PTSD [2 weeks]
Screening tool for PTSD symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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