A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

Study Overview
=================
Brief Summary
-----------------
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. We 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.

Detailed Description
-----------------
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, we 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. We will recruit participants across 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, we 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. We 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.

Official Title
-----------------
A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TranS-C<br>The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature. | Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction<br>* The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.<br>|
| Active Comparator: UC-DT<br>Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C. | Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction<br>* The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impairment (Sheehan Disability Scale) | Sheehan Disability Scale (sleep) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 
| Disorder-Focused Composite Score (DSM-5) | DSM-5 Cross Cutting Measure | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 
| Sleep and Circadian Function | PROMIS-Sleep Disturbance and PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression (QIDS) | QIDS (Quick Inventory of Depressive Symptoms) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 
| Substance use (ASSIST ) | ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 
| Psychotic symptoms (PSYRATS ) | PSYRATS (Psychotic Symptom Rating Scales) | 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) | Daily Sleep Diary means and variability for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 
| Actigraphy Measured Sleep | Actigraphy: Means and variability for Total sleep time (TST), Total wake time (TWT) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | 
| Daytime Activity (Actigraphy) | Actigraphy Measured Daytime Activity Count | 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) | Four question 'healthy days' core module developed by the CDC | 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 | Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation across the 7 day sleep diary), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint across the 7 day sleep diary), Efficiency (Sleep efficiency based on the 7 day sleep diary) and Duration (Total Sleep Time based on 7 day sleep diary). | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6- month followupt |