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OpenTrials
Completed

NCT Number: NCT05895318

Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stratton VA Medical Center

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Albany Research Institute, Inc.

Other

Registry information

Acronym: PMATAVP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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