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临床试验/NCT03229525
NCT03229525Unknown不适用

Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
162
试验地点
2
主要终点
Change in Posttraumatic Growth

研究概览

简要总结

Post-traumatic Stress Disorder (PTSD) is a debilitating mental disorder that affects approximately 7% of the general population. This project's aim is to develop a greater understanding of the efficacy and underlying mechanisms of narrative exposure based treatments for PTSD. Adult participants (N=162) who meet DSM-5 criteria for PTSD will be enrolled in a 3-arm randomized clinical trial consisting of trauma-related expressive writing, trauma-related expressive speaking, or a factual expressive writing control condition. Treatments will be manualized and conducted entirely through the Qualtrics survey platform. Treatment will consist of six sessions, three per week over two weeks, taking place via the internet. Assessments will be conducted pre-treatment, post-treatment, and at 1-month follow-up in the lab. Assessments will be comprised of symptom self-report measures as well as two tasks completed in an eye tracker: a reading task to evaluate mechanisms underlying trauma narrative processing and a sentence production task to evaluate attentional shifts when producing verbal information

Specific Aims and Hypotheses:

  1. Develop and test the relative efficacy of two cost-effective internet-based expressive trauma therapies (written vs. spoken) relative to a non-trauma writing control for PTSD. We hypothesize that both trauma-focused expressive therapies will achieve more favorable outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms, posttraumatic growth, and quality of life compared to the writing control.
  2. Conduct exploratory analyses testing baseline PTSD severity, depression severity, trauma type, time since trauma, and emotional engagement in moderating the differential effects of the selected expressive therapies.
  3. Test the moderation of (1) active language processing with eye tracking (i.e. how long certain words are fixated on). (2) selected linguistic elements (i.e., frequency of emotional words, frequency of the pronoun "I"), (3) perceived self-efficacy to cope with trauma memories; (4) perceived threat appraisals associated with intrusive trauma memories on treatment outcome at follow-up. We hypothesize that (1) fewer and shorter fixations on ideographic (i.e. personally relevant) trauma words when reading the trauma narrative in the eye tracker will be associated with reductions in PTSD symptoms at follow-up. (2) increased use of emotional words over the course of writing sessions will be associated with reductions in PTSD and depression symptoms at follow-up; (3) pre- to posttreatment increases in trauma memory acceptance self-efficacy; and (4) pre- to posttreatment reductions in trauma memory threat appraisals will be associated with greater symptom reduction at the follow-up assessment.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females between the ages of 18 and 65
  • Meets Diagnostic and Statistical Manual 5 criteria for PTSD
  • Able to give consent
  • Access to a computer in a private place
  • Completes initial writing samples online

排除标准

  • Impaired vision
  • Bipolar Disorder
  • Suicidality
  • Current trauma related treatment
  • Psychotropic medication <2 months or not stable (dosage variable) in past 2 months
  • Reading grade level > 6th grade level
  • Obsessive Compulsive Disorder
  • Traumatic Brain Injury

结局指标

主要结局

Change in Posttraumatic Growth

时间窗: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)

Post Traumatic Growth Inventory at each assessment

Change in Reading Task indices

时间窗: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)

Reading narratives in an eye tracker at each assessment

Change in Sentence Production Task indices

时间窗: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)

Describing images in an eye tracker at each assessment

Change in PTSD symptom severity

时间窗: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months)

PTSD Symptom Checklist at each assessment

Change in Depression symptoms

时间窗: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)

Becks Depression Inventory at each assessment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael J. Telch

Professor

University of Texas at Austin

研究点 (2)

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