Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
This study investigates the feasibility, acceptability, and effectiveness of adding Cognitive-Behavioral Therapy for Insomnia (CBT-I) to the standard care received at the Integrative Cardiac Health Project (ICHP) on insomnia symptoms and severity. ICHP is an established cardiovascular disease prevention program to reduce cardiovascular disease risk through the adoption of lifestyle changes related to improvements in diet, stress, sleep, and exercise. The study will be conducted among patients with insomnia who are already enrolled in the ICHP cardiovascular risk prevention program.
This is a single-center study, prospective, randomized, controlled, interventional trial within ICHP at the Walter Reed National Military Medical Center (WRNMMC). To conduct both phases of the study, up to 76 total male and female patients enrolled in ICHP who meet criteria for insomnia will be recruited. Participants who meet inclusion and exclusion criteria for this study, and consent to participate, will be randomized to one of two conditions: (1) ICHP, or (2) ICHP + CBT-I treatment. CBT-I treatment will consist of four in-person appointments and two telephone appointments.
详细描述
Methodology: Up to 76 total male and female patients enrolled in the ICHP who meet criteria for insomnia will be recruited. All ICHP patients meet the following criteria before enrolling in the program: military beneficiaries at least 18 years of age who are self-referred or referred by their physician.
Randomization: Participants will be selected for treatment groups based on a block randomization scheme. The total number of blocks will be 19, and the number of subjects per block will be 4. The treatment labels will be: ICHP and ICHP + CBT-I. The randomization scheme varies the sequence of treatment categories in each block.
Allocation concealment: The allocation sequence will be concealed from the research team enrolling participants in sequentially numbered, opaque, sealed, and stapled envelopes.
Once randomized, patients identified for the study will participate in the ICHP group or the ICHP + CBT-I group (which consists of the ICHP program plus a 6-session CBT-I treatment). The 6 sessions will consist of 4 in-person appointments and two telephone appointments. Each in-person session will be approximately 1 hour, and each phone session will be approximately 30 minutes.
The study data will be analyzed in two phases. Phase I will be a pilot study to determine the feasibility and acceptability of CBT-I within the ICHP program.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older, Tricare beneficiary, participation in ICHP
- •Sleep-onset or maintenance insomnia, defined as sleep-onset latency (SOL; time it takes to fall asleep) and/or wake after sleep onset (WASO; time spent awake after falling asleep) longer than 30 minutes per night at least 3 nights per week
- •Insomnia duration of at least 3 months
- •A complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) that is attributed to insomnia
- •Score of 8 or greater on the Insomnia Severity Index
- •Pittsburgh Sleep Quality Index (PSQI) score of > 5
排除标准
- •Previous participation in the ICHP program
- •Use of stimulant medications or acute high dose of steroids
- •Suicidal ideation, as determined by a score of 1 or greater on question #9 of the Patient Health Questionnaire-9 (PHQ-9)
- •Concurrent psychological or behavioral treatment for insomnia
- •Current pregnancy by history, or plans to become pregnant in the next 6 months (excluded because of sleep difficulties which often occur during pregnancy that could confound the results)
研究组 & 干预措施
ICHP + CBT-I
Participants in this arm will receive the usual care (ICHP program) plus 6 Cognitive-Behavior Therapy for Insomnia (CBT-I) treatment sessions. Four of the treatment sessions will be in person and two will be over the phone.
干预措施: Cognitive-Behavior Therapy for Insomnia (CBT-I) (Behavioral)
ICHP Only
Participants in this arm will receive the usual care (ICHP program).
结局指标
主要结局
Sleep Efficiency
时间窗: 2 months, 4 months, and 6 months
collected through sleep diary and actigraphy
次要结局
- Functional Outcomes of Sleep Questionnaire-10(2 months and 6 months)
- Pittsburgh Sleep Quality Index(2 months and 6 months)
- Patient Health Questionnaire-9(2 months, 4 months, and 6 months)
- Perceived Stress(2 months, 4 months, and 6 months)
- Epworth Sleepiness Scale(2 months, 4 months, and 6 months)
- Insomnia Severity Index(2 months, 4 months, and 6 months)
- Multidimensional Fatigue Inventory(2 months, 4 months, and 6 months)