Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI): A Pilot Randomized Controlled Trial for Service Members
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Insomnia Severity
研究概览
简要总结
The goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members.
The main questions it aims to answer are:
RQ1. Will the delivery of CBTI via a self-managed mobile application over five weeks improve sleep outcomes for service members?
RQ2. Will the delivery of CBTI via a self-managed mobile application over five weeks improve secondary outcomes (sleep-related impairment, depression, PTSD symptoms, and quality of life) for service members?
详细描述
Participants enrolled in this trial will:
- Week 1: Complete a series of questionnaires (approximately 15 minutes) & complete a daily sleep diary for one week (three minutes each morning).
- Weeks 2-6: Participate in one of two groups that are randomly assigned:
- Group 1: Starts use of the smart phone app with treatment for insomnia for five weeks. Each day during weeks 2-6 you will complete a daily sleep diary on the app and review individual sleep treatment recommendations (total of 5 minutes each morning).
OR
- Group 2: Will wait for five weeks
- End of Week 6: Both Group 1 & Group 2 will complete a series of questionnaires (approximately 15 minutes), & complete a daily sleep diary for one week (three minutes each morning).
- Week 10: Both Group 1 & Group 2 will complete a series of questionnaires (approximately 15 minutes) about insomnia symptoms, any sleep related impaired function, depression symptoms, post-traumatic stress disorder symptoms, and quality of life. Participants randomized to the wait list will be contacted to provide information and support on how to use the smart phone app for treatment with insomnia.
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
- None
盲法说明
All study participants will complete initial study questionnaires and sleep diary data for one week. At one week study participants will be randomized into groups. At this time the study will be unblinded to provide instructions on the intervention and to follow up with participants for questionnaire completion.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Duty, Reservist, Army National Guard
- •Ages 18-55 years
- •Own a smart phone
- •Internet access
排除标准
- •Insomnia Severity Score > or equal to 10
- •PHQ-8 score <20
- •Untreated sleep disorders (sleep apnea, narcolepsy, parasomnias)
- •Pregnancy
- •Working rotating Shifts
- •Caring for a newborn <3 months old
- •Currently receiving cognitive behavioral therapy for insomnia
- •Received cognitive behavioral therapy for insomnia in the last 6 months
研究组 & 干预措施
Digital App CBTI
Participants will use a digital app for self-directed CBTI for five weeks.
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Waitlist Control
This group will be placed on a waitlist control group until the follow up period is complete.
结局指标
主要结局
Insomnia Severity
时间窗: Baseline, Six Weeks, Nine Weeks
Insomnia severity will be measured with the Insomnia Severity Index (ISI). The ISI is a seven-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past 2 weeks (Appendix G).82 Items are rated on scales from 0 - 4 (none-severe). Item ratings are summed to get a total score, with higher scores reflecting greater insomnia severity (0-7 = no clinically significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinically significant insomnia -moderate, 22-28 = clinically significant insomnia - severe).
次要结局
- Consensus Sleep Diary(Baseline, Six Weeks)
- PROMIS Sleep-Related Impairment 8a(Baseline, Six Weeks, Nine Weeks)
- The PTSD Checklist-Military Version (PCL-M)(Baseline, Six Weeks, Ten Weeks)
- The Patient Health Questionnaire-8 (PHQ-8)(Baseline, Six Weeks, Nine Weeks)
- RAND-36(Baseline, Six Weeks, Ten Weeks)