A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Impairment (Sheehan Disability Scale)
研究概览
简要总结
Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to determine if an intervention to improve sleep can improve functioning and reduce symptoms and impairment. The investigators will conduct this study in community mental health centers to ensure that the results contribute to closing the worrisome gap between research and practice and to ensure that the findings are generalizable to the real world.
详细描述
Despite advances in treatment, severe mental illness (SMI) remains common, chronic and difficult to treat. SMI is defined as having at least one mental disorder that lasts for 12-months and leads to substantial life interference. Sleep and circadian dysfunctions are among the most prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced by people with SMI. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real life sleep and circadian problems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, the investigators aim to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. The investigators will recruit participants across Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses and across common sleep and circadian problems. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in community settings with community-based providers. Accordingly, the investigators propose to conduct an 'efficacy in the real world' randomized controlled trial within Alameda County Behavioral Health Care Services (ACBHCS), the community mental health center (CMHC) for Alameda County. The investigators will recruit 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS. Individuals will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before, immediately following treatment (ie. 9-14 weeks later) and again 6 months later.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18+ years
- •English language fluency
- •Presence of at least one DSM-V mental disorder for 12 months
- •One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview:
- •≥30 mins to get to sleep , 3 or more nights per week
- •Waking in the middle of the night for ≥30 minutes, 3 or more nights per week
- •Obtaining less than 6 hours of sleep per night, 3 or more nights per week
- •Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week
- •More than 2.78 hours of variability in sleep-wake schedule across one week
- •Bedtime later than 2 am, 3 or more nights per week
- •Guaranteed bed to sleep in for the duration of the treatment phase
- •Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager
排除标准
- •Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible.
- •Current serious suicide risk (assessed by our staff, a case manager or psychiatrist) or homicide risk (assessed by our staff, a case manager or psychiatrist)
- •Night shift work >2 nights per week in the past 3 months
- •Pregnancy or breast-feeding
- •Not able/willing to participate in and/or complete the pre-treatment assessments
结局指标
主要结局
Impairment (Sheehan Disability Scale)
时间窗: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.
Disorder-Focused Composite Score (DSM-5)
时间窗: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.
Impairment (Sheehan Disability Scale)
时间窗: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.
Disorder-Focused Composite Score (DSM-5)
时间窗: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.
Sleep and Circadian Function: PROMIS-Sleep Disturbance
时间窗: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance.
Sleep and Circadian Function: PROMIS-Sleep-Related Impairment
时间窗: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance.
次要结局
- Depression (QIDS)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Daytime Activity (Actigraphy)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Impairment (World Health Organization Disability Assessment Schedule 2.0)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Depression (QIDS)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Substance Use (ASSIST )(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Impairment (World Health Organization Disability Assessment Schedule 2.0)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Overall Health ('Healthy Days' Core Module)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Composite Sleep Health Score(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Means and Variability of Total Sleep Time (Daily Sleep Diary)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Means and Variability of Total Wake Time (Daily Sleep Diary)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Psychotic Symptoms (PSYRATS )(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Means and Variability of Sleep Efficiency (Daily Sleep Diary)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Actigraphy Measured Sleep (TST)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Daytime Activity (Actigraphy)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Means and Variability of Bedtime (Daily Sleep Diary)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Means and Variability of Wake Time (Daily Sleep Diary)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)
- Actigraphy Measured Sleep (TWT)(Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup)