A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TranS-C 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
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.
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| Active Comparator: UC-DT 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
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.
|
Outcome Measures
Primary Outcome Measures
- Impairment (Sheehan Disability Scale) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
Sheehan Disability Scale (sleep)
- Disorder-Focused Composite Score (DSM-5) [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
- Sleep and Circadian Function [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
PROMIS-Sleep Disturbance and PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)
Secondary Outcome Measures
- Depression (QIDS) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
QIDS (Quick Inventory of Depressive Symptoms)
- Substance use (ASSIST ) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
ASSIST (Alcohol, Smoking and Substance Involvement Screening Test)
- Psychotic symptoms (PSYRATS ) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
PSYRATS (Psychotic Symptom Rating Scales)
- 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]
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.
- Actigraphy Measured Sleep [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
Actigraphy: Means and variability for Total sleep time (TST), Total wake time (TWT)
- Daytime Activity (Actigraphy) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
Actigraphy Measured Daytime Activity Count
- 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]
Four question 'healthy days' core module developed by the CDC
- Composite Sleep Health Score [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6- month followupt]
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).
Other Outcome Measures
- Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview ) [Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted]
- Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
- Sleep and Circadian Problems Interview [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
- Insomnia Severity Index [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
- Hypersomnia Severity Index [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
- Therapy Process Measure [Administered at the end of Session 2 of treatment]
Credibility Expectancy Questionnaire
- Medication and Other Treatment Tracking form [Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup]
- Additional screen for sleep apnea [Baseline Only]
STOP BANG Questionnaire
- Brief Pain Inventory (Short Form) [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up]
Current symptoms of chronic pain
- Clinic Staff Qualitative Assessment [One time at the convenience of clinic staff]
Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting
- Client Behavior Change Interview [One time following the completion of the first post-treatment assessment]
Exploration of barriers and facilitators to behavior change
- Salivary Cytokine Assay [Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up]
Measure of cytokines present in saliva (e.g., IL-1 beta, IL-6, IL-8, TNF alpha, and/or CRP) to assess immune function
- Credibility Evaluation Questionnaire (CEQ) [Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.]
Client evaluation of treatment
- Patient Recall Task [Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up]
Participant recall of sleep coaching treatment
- Patient Learning Task (Application and Thoughts subsections) [Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up]
Client feedback and application of treatment
- Useful and Utilized Questionnaire [Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up]
Measure of sleep coaching elements used/useful to clients
- Treatment Adherence Rating Scale-Therapist Version [After each treatment session filled out by therapist (8 times)]
Therapist evaluation of client adherence to treatment
- Body weight [Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up]
To calculate BMI
- Height [Pre-treatment]
To calculate BMI
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18+ years
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English language fluency
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Presence of at least one DSM-V mental disorder for 12 months
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One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview:
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≥30 mins to get to sleep , 3 or more nights per week
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Waking in the middle of the night for ≥30 minutes, 3 or more nights per week
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Obtaining less than 6 hours of sleep per night, 3 or more nights per week
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Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week
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More than 2.78 hours of variability in sleep-wake schedule across one week
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Bedtime later than 2 am, 3 or more nights per week
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Guaranteed bed to sleep in for the duration of the treatment phase
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Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager
Exclusion Criteria:
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Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible.
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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)
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Night shift work >2 nights per week in the past 3 months
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Pregnancy or breast-feeding
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Not able/willing to participate in and/or complete the pre-treatment assessments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alameda Country Behavioral Health Care Services | Oakland | California | United States | 94605 |
Sponsors and Collaborators
- University of California, Berkeley
- Alameda County Behavioral Health Care Services
- University of Pittsburgh
Investigators
- Principal Investigator: Allison G Harvey, PhD, University of California, Berkeley
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01MH105513