A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

NCT02469233 | Completed Results DMC

• 1 other identifier: R01MH105513
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (4)

• Impairment (Sheehan Disability Scale)

  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.

  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. 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.

  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

  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.

  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-Related Impairment

  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.

  Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

Secondary Outcomes (14)

• 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

• 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

Other Outcomes (19)

• 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

Study Arms (2)

TranS-C

EXPERIMENTAL

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

UC-DT

ACTIVE COMPARATOR

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

Interventions

Transdiagnostic Intervention for Sleep and Circadian Dysfunction BEHAVIORAL

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.

TranS-C; UC-DT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• Alameda County Behavioral Health Care Services: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Alameda Country Behavioral Health Care Services

Oakland, California, 94605, United States

Location

Related Publications (4)

• Callaway CA, Sarfan LD, Gumport NB, Harvey AG. The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C). Behav Res Ther. 2023 Sep;168:104368. doi: 10.1016/j.brat.2023.104368. Epub 2023 Jul 5.

  PMID: 37478529 DERIVED

• 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.

  PMID: 34264701 DERIVED

• 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.

  PMID: 32890862 DERIVED

• 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.

  PMID: 27998295 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Professor of Clinical Psychology
• Organization: Department of Psychology, University of California, Berkeley

aharvey@berkeley.edu

5104736490

Study Officials

• Allison G Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: May 1, 2015
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Locations

US (1)