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临床试验/NCT00350584
NCT00350584已完成不适用

Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation

VA Boston Healthcare System2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Clinician Administered PTSD Scale (CAPS)

研究概览

简要总结

Posttraumatic Stress Disorder (PTSD) is very prevalent within the veteran population and is associated with decreased quality of life and an increased risk of developing other psychiatric and physical illnesses. The overarching objective of the proposed study is to evaluate the effectiveness of two telehealth treatment conditions in promoting healing within a population of veterans with full or partial PTSD. In particular, we are targeting newly returned veterans from the Iraq and Afghanistan conflicts. Specifically, we are comparing the relative efficacy of an alternative therapeutic approach, a Mindfulness based treatment, with a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric symptoms, while increasing quality of life. Of note, both treatment conditions will consist of two in-person sessions and six brief weekly telephone calls. Participants will be 58 veterans (29 per condition) recruited from the VA Boston Healthcare System. Assessment will occur before and after the delivery of the intervention. We hypothesize that while both treatments will result in improved outcomes, the Mindfulness intervention will promote more healing than the Psychoeducation intervention. Results from this project will help further our understanding of the role of mindfulness in treating PTSD, particularly in those veterans who are returning from deployment.

详细描述

Aim: To evaluate the relative feasibility and healing efficacy of two eight-week telehealth interventions for individuals with combat-related PTSD: (1) Mindfulness and (2) Psychoeducation.

Objectives:

  1. The first short-term objective is to determine whether two eight-week telehealth interventions are:

  2. feasible to conduct in a population of veterans with symptoms of combat-related PTSD;

  3. effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD;

  4. effective at promoting more generalized healing in combat veterans as evidenced by reductions in symptoms that are often co-morbid with PTSD (e.g., depression, anxiety, and substance abuse problem severity); and

  5. effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions.

  6. The second short-term objective of this study is to determine whether a Mindfulness intervention will be more effective at promoting healing than a Psychoeducation intervention. This comparison will be made on the levels of specific PTSD symptoms, more general co-morbid symptoms, and global quality of life.

  7. The long-term objectives of this line of research are to identify mechanisms of action in a Mindfulness Telehealth Intervention that allow healing and promote increased quality of life in individuals with PTSD.

  8. An additional long-term objective of this project is to contribute to the development of efficacious wellness interventions that can promote healing after combat exposure in veterans returning from current military conflicts (e.g. Iraq and Afghanistan).

Hypotheses:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • documented United States military service in war or peacekeeping theater
  • a current diagnosis of PTSD or partial PTSD
  • access to a telephone

排除标准

  • veteran's mental status precludes completion of the assessment procedures (e.g., severe organicity or active psychosis)
  • the veteran's regimen of psychiatric medication has not been stable over the past two months (if applicable)
  • the veteran has symptoms consistent with a diagnosis of alcohol or drug dependence within the past three months.

结局指标

主要结局

Clinician Administered PTSD Scale (CAPS)

时间窗: pre and post intervention

Gold standard instrument to assess symptoms of PTSD. Administered by a clinician.

次要结局

  • PTSD Checklist(pre and post intervention)

研究者

申办方类型
Fed

研究点 (2)

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