title: A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial.
abstract: Severe mental illness (SMI) is common, chronic and difficult to treat. Sleep and circadian dysfunctions are prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem in a specific diagnostic group. However, real life sleep and circadianproblems 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 aim of this studyprotocol is 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. Participants across DSM diagnoses and across common sleep and circadian problems are eligible. 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 a community setting. Accordingly, this study is being conducted within Alameda County Behavioral Health Care Services (ACBHCS), the Community Mental Health Centre (CMHC) for Alameda County.
  
  
  
  120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS 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 and immediately following treatment and again 6 months later. Primary analysis will examine whether TranS-C significantly improves functional impairment, disorder-specific symptoms and sleep and circadian functioning, relative to UC-DT. Exploratory analysis will examine whether improvements in sleep and circadian functioning predict reduction in functional impairment and disorder-specific symptoms, and whether the intervention effects are mediated by improved sleep and circadian functioning and moderated by previously reported risk factors (demographics, symptom severity, medications, psychiatric and medical comorbidity).
  
  
  
  This trial tests an important and understudied mechanism-dysregulated sleep and circadian rhythms-in SMI, a novel transdiagnostic treatment approach, in a community setting so as to contribute to the goal of bridging the gap between research and practice.
  
  
  
  ClinicalTrials.gov identifier: NCT02469233 . Registered on 9 June 2015.
authors.affiliation: Department of Psychology, University of California, 2205 Tolman Hall #1650, Berkeley, CA, 94720-1650, USA. aharvey@berkeley.edu.
authors.forename: Allison G
authors.initials: AG
authors.lastname: Harvey
authors.affiliation: Department of Psychology, University of California, 2205 Tolman Hall #1650, Berkeley, CA, 94720-1650, USA.
authors.forename: Kerrie
authors.initials: K
authors.lastname: Hein
authors.affiliation: Department of Psychology, University of California, 2205 Tolman Hall #1650, Berkeley, CA, 94720-1650, USA.
authors.forename: Lu
authors.initials: L
authors.lastname: Dong
authors.affiliation: Alameda County Behavioral Health Care Services, Oakland, CA, USA.
authors.forename: Freddie L
authors.initials: FL
authors.lastname: Smith
authors.affiliation: Alameda County Behavioral Health Care Services, Oakland, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Lisman
authors.affiliation: Department of Psychology, University of California, 2205 Tolman Hall #1650, Berkeley, CA, 94720-1650, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Yu
authors.affiliation: Department of Education, University of California, 2205 Tolman Hall #1650, Berkeley, CA, 94720-1650, USA.
authors.forename: Sophia
authors.initials: S
authors.lastname: Rabe-Hesketh
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Buysse
mesh_terms: D000328:Adult; D002140:California; D002940:Circadian Rhythm; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008875:Middle Aged; D011446:Prospective Studies; D011613:Psychotherapy / Q000379:methods*; D012107:Research Design; D012720:Severity of Illness Index; D012890:Sleep; D020178:Sleep Disorders, Circadian Rhythm / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Dissemination; Severe mental illness; Sleep; Transdiagnostic; circadian