Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

NCT05895318 | Completed

• 1 other identifier: 061006
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

MDMA; MDMA-Assisted Therapy; Psychedelic; PTSD

Outcome Measures

Primary Outcomes (3)

• Patient Health Questionnaire 9

  Screening tool for depressive symptoms. Scores range from 0-27 with lower scores indicating better outcomes

  2 weeks

• PTSD Checklist for DSM5

  Screening tool for PTSD symptoms. Scores range from 0-80 with lower scores indicating better outcomes

  4 weeks

• 5 Item Screener for PTSD

  Screening tool for PTSD symptoms. Scores range from 0-4 with lower scores indicating better outcomes.

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cognitively impaired to the extent that patient cannot comprehend the survey
• Has already completed the interview

Sponsors & Collaborators

• Albany Research Institute, Inc.: lead

Study Sites (1)

Stratton VA Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Caitlin Holley, Ph.D.

  Stratton VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: August 8, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)