跳至主要内容
临床试验/NCT01419223
NCT01419223已完成不适用

Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Perceptions about participation in clinical trials for PTSD or TBI as measured via qualitative interview.

研究概览

简要总结

This is an exploratory qualitative interview study being conducted with a primary objective of examining perceptions held by active military and veterans regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI) clinical trials. Active duty military and/or veterans aged 18 years and older who consent to participate (N = 50), or have recently declined participation (N = 50), in an INTRuST affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited. Participants who consent to participate in an INTRuST clinical trial (Group 1) will be interviewed once at the beginning the of the clinical trial, and again following participation in the trial. Participants who decline participation in an INTRuST affiliated outpatient clinical trial (Group 2) will be interviewed once. For participants in both groups, study participation will initiate within 1 month of referral to study. Total duration of study participation is based on the specific clinical trial that the participant is recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured qualitative individual interviews will be conducted to carry out a thematic analysis of the data exploring familial, social and institution-level constructs which may influence the subjective experience of the research treatment process.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Age between 18 and over
  • Active duty and/or veteran
  • Referred to participate in INTRuST-affiliated outpatient clinical trials for PTSD or TBI
  • Ability to provide written informed consent

排除标准

  • 未提供

结局指标

主要结局

Perceptions about participation in clinical trials for PTSD or TBI as measured via qualitative interview.

时间窗: Qualitative interviews will be conducted during an expected average time frame of 12-24 weeks per study participant based on the specific study recruited from.

Perceptions regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in clinical treatment trials for PTSD-TBI will be measured via serial qualitative interview framework.

次要结局

  • Feasibility of conducting qualitative interviews with active duty military and veterans who consent or decline participation in a PTSD or TBI clinical trial as measured by study participation.(End of 21-month study recruitment period)

研究者

发起方
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
申办方类型
Other
责任方
Sponsor

研究点 (1)

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