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临床试验/NCT00640445
NCT00640445已完成2 期

Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration

Minneapolis Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 1,292 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
1,292
试验地点
2
主要终点
PTSD symptoms

研究概览

简要总结

Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life. Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian populations, but its efficacy in combat veterans has not been tested. This study therefore seeks to test the efficacy of Expressive Writing in a veteran population while further enhancing its accessibility by delivering it over the internet (Internet-Based Expressive Writing; IB-EW). This study will comprise a randomized controlled trial with three conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across these groups. Expressive Writing participants will write with feeling about their transition from being a soldier to being a civilian; Control Writing participants will write factually about the information needs of new veterans; and Treatment as Usual participants will complete the assessments but not engage in any writing assignments. Participants will complete standardized self-report measures of psychological symptoms, psychosocial functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6) and six months (Session 7) post-intervention. Participants in writing conditions will write for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline measures (participants in the TAU condition will not complete Sessions 2-5). The study will also attempt to identify individual difference characteristics related to the efficacy of the treatment, to see who may be most likely to benefit from the treatment. Analyses will primarily entail multivariate analyses of variance. Power is adequate to detect even a small effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Veteran from current wars in Iraq and Afghanistan
  • At least a little difficulty transitioning from soldier to civilian
  • Access to computer with internet
  • Provide valid contact information
  • Available to participate for up to 40 minutes per session
  • Interested in participation
  • Understand procedures and consent
  • Note: participants are recruited by random selection from the target population

排除标准

  • Severe depression

结局指标

主要结局

PTSD symptoms

时间窗: Baseline, 3-month, 6-month

Physical symptoms

时间窗: Baseline, 3-month, 6-month

Social support

时间窗: Baseline, 3-month, 6-month

Life satisfaction

时间窗: Baseline, 3-month, 6-month

Hostility

时间窗: Baseline, 3-month, 6-month

Psychological distress

时间窗: Baseline, 3-month, 6-month

Reintegration difficulty

时间窗: Baseline, 3-month, 6-month

次要结局

  • Employment status(Baseline, 3-month, 6-month)
  • Emotion and causal word use in participants' essays(Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition))

研究者

发起方
Minneapolis Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Nina A. Sayer

Associate Director, CCDOR; Research Director, PTBRI QUERI

Minneapolis Veterans Affairs Medical Center

研究点 (2)

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