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临床试验/NCT04552782
NCT04552782招募中不适用

PTSD, AUD, and Interpersonal Conflict: Within-person Associations

University of South Dakota6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
6
主要终点
Rate of PTSD Symptoms

研究概览

简要总结

The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • OIF/OEF/OND veterans
  • At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))

排除标准

  • Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)
  • Active suicidal or homicidal ideation that contraindicates participation (based on interview)
  • [exclusion criteria removed 6/2022] - Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea

结局指标

主要结局

Rate of PTSD Symptoms

时间窗: 2 years

These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).

Rate of Alcohol Use Disorder Symptoms

时间窗: 2 years

These are experience sampling items derived from Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

次要结局

未报告次要终点

研究者

发起方
University of South Dakota
申办方类型
Other
责任方
Sponsor

研究点 (6)

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