Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

Post Traumatic Stress Disorder Clinical Trial

— PMATAVP  

Official title:

Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895318
• Other study ID #: 061006
• Status: Completed
• Start date: August 8, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: June 2023
• Source: Albany Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Stratton VA Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire 9	Screening tool for depressive symptoms. Scores range from 0-27 with lower scores indicating better outcomes	2 weeks
Primary	PTSD Checklist for DSM5	Screening tool for PTSD symptoms. Scores range from 0-80 with lower scores indicating better outcomes	4 weeks
Primary	5 Item Screener for PTSD	Screening tool for PTSD symptoms. Scores range from 0-4 with lower scores indicating better outcomes.	2 weeks