Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Nightmare Disorders Index
研究概览
简要总结
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
详细描述
The aims of the study are:
- Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
- Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
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 (Outcomes Assessor)
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
- •Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
- •Ability to speak and read English.
- •Clinically significant PTSD symptoms (CAPS-5 > 25 with at least one Intrusion symptom and at least one Avoidance symptom).
- •Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) > 11).
- •Nightmares > 1 monthly (as reported on the SCISD).
- •Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.
排除标准
- •Current suicide or homicide risk meriting crisis intervention.
- •Inability to comprehend the baseline screening questionnaires.
- •Unwilling to remain abstinent from alcohol during therapy sessions.
- •Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
- •Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
- •Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
- •Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.
结局指标
主要结局
Nightmare Disorders Index
时间窗: Change from baseline through 3 and 6 month assessments
The NDI is a self-report assessment of nightmare disorder.
Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: Change from baseline through 3 and 6 month follow-up assessment
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).
Insomnia Severity Index (ISI)
时间窗: Change from baseline through 3 and 6 month follow up
The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).
次要结局
- Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)(Change from baseline to 1-month follow-up assessment)
- Generalized Anxiety Disorder Screener (GAD-7)(Change from baseline through 3 and 6 month follow-up assessment)
- Trauma-Related Nightmare Survey (TRNS)(Change from baseline through 3 and 6 month follow-up assessment)
- Depressive Symptoms Index-Suicidality Subscale (DSI-SS)(Change from baseline through 3 and 6 month follow up assessment)
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline through 3 and 6 follow-up assessment)
- Brief Inventory of Psychosocial Functioning (B-IPF)(Change from baseline through 3 and 6 month follow up)
- Clinician Administered PTSD Scale (CAPS-5)(Change from baseline to 1-month follow-up assessment)
- Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)(Change from baseline to 1-month follow-up assessment)
- Generalized Anxiety Disorder Screener (GAD-7)(Change from baseline through 3 and 6 month follow-up assessment)
- Trauma-Related Nightmare Survey (TRNS)(Change from baseline through 3 and 6 month follow-up assessment)
- Depressive Symptoms Index-Suicidality Subscale (DSI-SS)(Change from baseline through 3 and 6 month follow up assessment)
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline through 3 and 6 follow-up assessment)
- Brief Inventory of Psychosocial Functioning (B-IPF)(Change from baseline through 3 and 6 month follow up)
研究者
Carmen McLean
Clinical Psychologist
Palo Alto Veterans Institute for Research