An Efficient Treatment for Posttraumatic Injury for Firefighters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
研究概览
简要总结
The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are:
- Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
- What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:
- Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
- Attend an individual treatment orientation session
- Attend a 4-day (~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
- Attend an individual booster session held approximately one week later
- Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.
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
- •18-65 years old
- •Firefighter
- •Able to speak and read English
- •Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom
- •Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15
- •Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly.
排除标准
- •Current suicide or homicide risk meriting crisis intervention
- •Inability to speak and read English
- •Inability to comprehend the baseline screening questionnaires
- •Unwilling to remain abstinent from alcohol during treatment
- •Serious mental health diagnosis such as bipolar disorder or psychosis.
结局指标
主要结局
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
时间窗: Change from baseline to post treatment (~4 weeks post baseline)
The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.
Insomnia Severity Index (ISI)
时间窗: Change from baseline through 3 months post treatment
The ISI assesses perceived severity of insomnia.
Nightmare Disorders Index
时间窗: Change from baseline through 3 months post treatment
The NDI is a self-report assessment of nightmare disorder.
Clinician Administered PTSD Scale (CAPS-5)
时间窗: Change from baseline to post treatment (~4 weeks post baseline)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.
Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: Change from baseline through 3 months post treatment
Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.
次要结局
- Sleep Diary and Nightmare Log(Change from baseline through post treatment (~4 weeks post baseline))
- Trauma-Related Nightmare Survey (TRNS)(Change from baseline through 3 months post treatment)
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline through 3 months post treatment)
- Depressive Symptoms Index-Suicidality Subscale (DSI-SS)(Change from baseline through 3 months post treatment)
- Self-Assessment of Sleep (SASS)(Change from baseline through 3 months post treatment)
- Net Prompter Score(Post treatment (~4 weeks post baseline))
研究者
Carmen McLean
Clinical Psychologist
Palo Alto Veterans Institute for Research