Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD (PMATAVP)

• ClinicalTrials.gov Identifier: NCT05895318
• Recruitment Status: Completed
• First Posted: June 8, 2023
• Last Update Posted: June 22, 2023
• Sponsor: Albany Research Institute, Inc.
• Information provided by (Responsible Party): Albany Research Institute, Inc.

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
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. 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 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: August 8, 2022
• Actual Primary Completion Date: March 23, 2023
• Actual Study Completion Date: March 23, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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. PTSD Checklist for DSM5 [ Time Frame: 4 weeks ]
   Screening tool for PTSD symptoms. Scores range from 0-80 with lower scores indicating better outcomes
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Locations

United States, New York

Stratton VA Medical Center

Albany, New York, United States, 12208

Sponsors and Collaborators

Albany Research Institute, Inc.

Investigators

• Principal Investigator: Caitlin Holley, Ph.D.; Stratton VA Medical Center

More Information

• Responsible Party: Albany Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT05895318
• Other Study ID Numbers: 061006
• First Posted: June 8, 2023
• Last Update Posted: June 22, 2023
• Last Verified: June 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Albany Research Institute, Inc.:

MDMA; MDMA-Assisted Therapy; Psychedelic; PTSD

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders