A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Posttraumatic Stress Disorder (PTSD) Checklist Diagnostic & Statistical Manual of Mental Disorders (DSM) 5 (PCL-5) to measure change from baseline self-reported symptoms of PTSD at the endpoint of the therapy (after completing 12 sessions) and follow-ups
研究概览
简要总结
Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which psychotherapy is widely practiced. Depression is one of the most common co morbid disorders when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and depression have been related to a reduced specificity in autobiographical memory.
Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET) in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will also attempt to develop protocols to implement this new technology into clinical practice and collect data to develop a treatment progress prediction model.
Study design: A randomized controlled intervention study.
Study population: 144 individuals with memories of CSA or war related trauma and symptoms of PTSD and/or depression.
Intervention: VRET or TAU.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •principal diagnosis meeting DSM-IV criteria for PTSD and/or major depression following CSA or war related trauma
- •between the ages of 18 and 70-years-old
- •having sufficient fluency in Dutch to complete treatment and research protocol
排除标准
- •current bipolar disorder
- •current psychotic disorders
- •current suicidality
- •high dissociation level (Dissociative Experiences Scale (DES) cut-off score ≥ 40)
研究组 & 干预措施
TAU
Treatment As Usual
干预措施: TAU (Behavioral)
结局指标
主要结局
Posttraumatic Stress Disorder (PTSD) Checklist Diagnostic & Statistical Manual of Mental Disorders (DSM) 5 (PCL-5) to measure change from baseline self-reported symptoms of PTSD at the endpoint of the therapy (after completing 12 sessions) and follow-ups
时间窗: At pre (baseline), post (after 12 therapy sessions with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements
The PCL-5 is a brief assessment that identifies the presence and symptom severity of PTSD. We use the PCL-5 to measure self-reported symptoms of PTSD.
Beck Depression Inventory-II (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 12 sessions) and follow-ups
时间窗: At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements
The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. We use the BDI-II to measure self-reported symptoms of depression.
次要结局
- The Outcome Questionnaire-45-2 (OQ-45-2) to measure change from baseline self-reported symptoms and well-being at the endpoint of the therapy (after completing 12 sessions) and follow-ups(At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks) and follow up (3 and 12 months post treatment) measurements)
研究者
Ingmar Franken
Professor of Clinical Psychology
Erasmus Medical Center