跳至主要内容
临床试验/NCT05895318
NCT05895318已完成不适用

Perceptions of MDMA-Assisted Therapy Among Veterans With PTSD

Albany Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
PTSD Checklist for DSM5

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

PTSD Checklist for DSM5

时间窗: 4 weeks

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

5 Item Screener for PTSD

时间窗: 2 weeks

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

Patient Health Questionnaire 9

时间窗: 2 weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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