A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares Compared to Waitlist Control in Active Duty Military Personnel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of nightmares reported on the Nightmare Log
研究概览
简要总结
The purpose of this study is to obtain preliminary data of the efficacy of Exposure, Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.
详细描述
This will be a pilot randomized controlled trial to compare the effects of Exposure, Relaxation, and Rescripting Therapy for military populations (ERRT-M) among active duty service members. Participants will be randomized to 5 sessions of ERRT-M (n = 20 ) or to a 5-week waitlist control group (WL; n = 20).
Participants will complete all interviews and self-report measures 1 weeks following treatment or the WL condition and 1 month after completing treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Active duty military stationed at Fort Hood as assessed by self-report.
- •Able to speak and read English.
- •History of a traumatic event.
- •Nightmare Disorder
- •Stable on psychotropic and/or hypnotic medications and/or interventions for sleep (e.g., Continuous Positive Air Pressure for sleep apnea) administered by other providers for at least one month assessed by self-report and review of medical record.
- •Willingness to refrain from beginning new behavioral health or medication treatment for issues pertaining to sleep, PTSD, or nightmares during participation in the study.
- •Indication that the SM plans to be in the area for the 5 months following the first assessment
排除标准
- •Current suicide or homicide risk meriting crisis intervention.
- •Severe brain damage, assessed by the inability to comprehend baseline questionnaires.
- •Pregnancy at baseline.
- •Serious mental health diagnosis such as bipolar disorder or psychosis, assessed with the pre-treatment health interview and review of medical record.
- •Currently taking propranolol.
- •Currently engaged in evidence-based treatment for PTSD (i.e., Prolonged Exposure Therapy or Cognitive Processing Therapy) or Insomnia (i.e., Cognitive Behavioral Therapy for Insomnia).
研究组 & 干预措施
ERRT-M for Nightmares
Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) -
干预措施: ERRT-M for Nightmares (Behavioral)
Waitlist control
Participants randomized to the Waitlist control condition will be contacted once weekly for 5 weeks to monitored status and then invited to participant in treatment.
结局指标
主要结局
Number of nightmares reported on the Nightmare Log
时间窗: Change from baseline to 2-week posttreatment
次要结局
- Total score on the Insomnia Severity Index (ISI)(Change from baseline to 2-week posttreatment)
- Total score on the Clinician Administered PTSD Scale (CAPS-5)(Change from baseline to 2-week posttreatment)
- Total score on the PTSD Checklist -DSM-5 (PCL-5)(Change from baseline to 2-week posttreatment)
- Total score on the Patient Health Questionnaire (PHQ-9)(Change from baseline to 2-week posttreatment)