- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02469233
A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
December 20, 2019 updated by: University of California, Berkeley
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
121
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States, 94605
- Alameda Country Behavioral Health Care Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impairment (Sheehan Disability Scale)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Sheehan Disability Scale (sleep)
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Disorder-Focused Composite Score (DSM-5)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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DSM-5 Cross Cutting Measure
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Sleep and Circadian Function
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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PROMIS-Sleep Disturbance and PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression (QIDS)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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QIDS (Quick Inventory of Depressive Symptoms)
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Substance use (ASSIST )
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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ASSIST (Alcohol, Smoking and Substance Involvement Screening Test)
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Psychotic symptoms (PSYRATS )
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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PSYRATS (Psychotic Symptom Rating Scales)
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Means and Variability of sleep efficiency (Daily Sleep Diary)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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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.
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Actigraphy Measured Sleep
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Actigraphy: Means and variability for Total sleep time (TST), Total wake time (TWT)
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Daytime Activity (Actigraphy)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Actigraphy Measured Daytime Activity Count
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Impairment (World Health Organization Disability Assessment Schedule 2.0)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Overall Health ('Healthy Days' core module)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Four question 'healthy days' core module developed by the CDC
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Composite Sleep Health Score
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6- month followupt
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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).
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6- month followupt
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )
Time Frame: Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
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Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
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Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Sleep and Circadian Problems Interview
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Insomnia Severity Index
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Hypersomnia Severity Index
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Therapy Process Measure
Time Frame: Administered at the end of Session 2 of treatment
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Credibility Expectancy Questionnaire
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Administered at the end of Session 2 of treatment
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Medication and Other Treatment Tracking form
Time Frame: Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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Additional screen for sleep apnea
Time Frame: Baseline Only
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STOP BANG Questionnaire
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Baseline Only
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Brief Pain Inventory (Short Form)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
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Current symptoms of chronic pain
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
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Clinic Staff Qualitative Assessment
Time Frame: One time at the convenience of clinic staff
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Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting
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One time at the convenience of clinic staff
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Client Behavior Change Interview
Time Frame: One time following the completion of the first post-treatment assessment
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Exploration of barriers and facilitators to behavior change
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One time following the completion of the first post-treatment assessment
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Salivary Cytokine Assay
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
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Measure of cytokines present in saliva (e.g., IL-1 beta, IL-6, IL-8, TNF alpha, and/or CRP) to assess immune function
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Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
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Credibility Evaluation Questionnaire (CEQ)
Time Frame: Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
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Client evaluation of treatment
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Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
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Patient Recall Task
Time Frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
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Participant recall of sleep coaching treatment
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Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
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Patient Learning Task (Application and Thoughts subsections)
Time Frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
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Client feedback and application of treatment
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Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
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Useful and Utilized Questionnaire
Time Frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
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Measure of sleep coaching elements used/useful to clients
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Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
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Treatment Adherence Rating Scale-Therapist Version
Time Frame: After each treatment session filled out by therapist (8 times)
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Therapist evaluation of client adherence to treatment
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After each treatment session filled out by therapist (8 times)
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Body weight
Time Frame: Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
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To calculate BMI
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Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
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Height
Time Frame: Pre-treatment
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To calculate BMI
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Pre-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Harvey AG, Dong L, Hein K, Yu SH, Martinez AJ, Gumport NB, Smith FL, Chapman A, Lisman M, Mirzadegan IA, Mullin AC, Fine E, Dolsen EA, Gasperetti CE, Bukosky J, Alvarado-Martinez CG, Kilbourne AM, Rabe-Hesketh S, Buysse DJ. A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. J Consult Clin Psychol. 2021 Jun;89(6):537-550. doi: 10.1037/ccp0000650.
- Gumport NB, Yu SH, Harvey AG. Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders. Psychiatry Res. 2020 Nov;293:113443. doi: 10.1016/j.psychres.2020.113443. Epub 2020 Aug 31.
- Harvey AG, Hein K, Dong L, Smith FL, Lisman M, Yu S, Rabe-Hesketh S, Buysse DJ. A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial. Trials. 2016 Dec 20;17(1):606. doi: 10.1186/s13063-016-1690-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2015
Primary Completion (ACTUAL)
April 17, 2019
Study Completion (ACTUAL)
April 17, 2019
Study Registration Dates
First Submitted
June 9, 2015
First Submitted That Met QC Criteria
June 10, 2015
First Posted (ESTIMATE)
June 11, 2015
Study Record Updates
Last Update Posted (ACTUAL)
December 24, 2019
Last Update Submitted That Met QC Criteria
December 20, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH105513 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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