Sleep's Influence on the Treatment of Intrusive Emotional Memories With Trauma-focused CBT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Clinician- assessed Posttraumatic stress symptom severity at 1 week
研究概览
简要总结
Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. The current study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.
详细描述
Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. However, not all patients benefit equally and only about 50% show sustained response. There is thus room for improvement in terms of (i) better understanding who benefits from this type of therapy and (ii) possible ways of augmenting existing trauma-focused therapies. The current study aims to contribute to these endevours. Specifically, the study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Psychotherapists and outcome assessors are blind to participants' group membership (i.e., sleep versus wake after exposure therapy)
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
- 否
入选标准
- •DSM V criteria of PTSD (at least moderate symptoms in two categories)
- •Currently receiving Written Exposure Therapy at one of the psychotherapy centers at the Psychiatric University Clinic (PUC).
- •Not more than moderate alcohol consumption (not more than 5 alcoholic drinks/week).
- •Ability to understand the study instructions
排除标准
- •Travel over > 3 time zones in < 3 months
- •head injury
- •shift work
- •current substance abuse
- •neurological disease
- •drug addiction
- •Current suicidality
- •Specific exclusion criteria for the fMRI:
- •Acute psychotic symptoms
- •Pregnancy
- •Claustrophobia
- •Magnetic resonance imaging incompatibility:
- •Cardiac pacemaker or other metallic implants (e.g. metallic cardiac valve, insulin pump)
- •Metallic foreign particles (e.g. after bullet wound, shell splinter, clips, metal prostheses)
结局指标
主要结局
Clinician- assessed Posttraumatic stress symptom severity at 1 week
时间窗: One week post- treatment
Clinician- assessed PTSD symptom severity (CAPS- 5)
Self-reported Posttraumatic stress symptom severity at 1 week
时间窗: One week post- treatment
Self - reported PTSD symptom severity (PCL-5)
Clinician- assessed Posttraumatic stress symptom severity at 1 month
时间窗: One month post- treatment
Clinician- assessed PTSD symptom severity (CAPS- 5)
Self-reported Posttraumatic stress symptom severity at 1 month
时间窗: One month post- treatment
Self - reported PTSD symptom severity (PCL-5)
次要结局
- Time spent in N2 sleep(Immediately after written exposure therapy)
- Total sleep time(Immediately after written exposure therapy)
- Time spent in N1 sleep(Immediately after written exposure therapy)
- Time spent in N3 sleep(Immediately after written exposure therapy)