Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- World Health Organization Quality of Life (WHOQOL-BREF)
研究概览
简要总结
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
详细描述
This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.
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)
盲法说明
The clinical interviewer conducting outcome-related interviews will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy
- •Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
- •Meet DSM-5 Criteria for Insomnia Disorder
- •Willing to attend all treatment and assessment appointments
- •English literacy and cognition sufficient to participate in treatment and assessment
排除标准
- •Psychosis or manic episode in last 5 years
- •Moderate or severe substance use disorder in past 6 months
- •Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial
- •Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial
- •Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
- •Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator)
- •Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator)
- •Working night shifts or rotating shifts that include night shifts
- •Lack of stable housing
- •Pregnancy
研究组 & 干预措施
Apnea and Insomnia Relief (AIR)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
干预措施: Apnea and Insomnia Relief (AIR) (Behavioral)
Sleep Education (SE)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
干预措施: Sleep Education (SE) (Behavioral)
结局指标
主要结局
World Health Organization Quality of Life (WHOQOL-BREF)
时间窗: Change from baseline to 1 week post-treatment (after 6 weeks)
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
World Health Organization Quality of Life (WHOQOL-BREF)
时间窗: Change from baseline to 3 months after treatment ends
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
次要结局
- Functional Outcomes of Sleep Questionnaire (FOSQ-10)(Change from baseline to 1 week post-treatment (after 6 weeks))
- Insomnia Severity Index (ISI)(Change from baseline to 1 week post-treatment (after 6 weeks))
- CPAP Adherence(Past 7 days, at 1 week after treatment ends)
- Functional Outcomes of Sleep Questionnaire (FOSQ-10)(Change from baseline to 3 months after treatment ends)
- Insomnia Severity Index (ISI)(Change from baseline to 3 months after treatment ends)
- CPAP Adherence(Past 7 days, at 3 months after treatment ends)
- Clinician Administered PTSD Scale for DSM-5 (CAPS-5)(Change from baseline to 1 week post-treatment (after 6 weeks))
- Total Sleep Time (Actigraphy-based)(Change from baseline to 1 week post-treatment (after 6 weeks))