Clinical trial NCT02469233: A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Official title: A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Alameda County Behavioral Health Care Services
name: University of Pittsburgh
First posted: 2015-06-11
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Impairment (Sheehan Disability Scale)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Disorder-Focused Composite Score (DSM-5)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Sleep and Circadian Function
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary outcomes:
measure: Depression (QIDS)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Substance use (ASSIST )
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Psychotic symptoms (PSYRATS )
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Means and Variability of sleep efficiency (Daily Sleep Diary)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Actigraphy Measured Sleep
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Daytime Activity (Actigraphy)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Impairment (World Health Organization Disability Assessment Schedule 2.0)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Overall Health ('Healthy Days' core module)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Composite Sleep Health Score
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6- month followupt
Other outcomes:
measure: Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )
timeFrame: Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
measure: Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Sleep and Circadian Problems Interview
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Insomnia Severity Index
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Hypersomnia Severity Index
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Therapy Process Measure
timeFrame: Administered at the end of Session 2 of treatment
measure: Medication and Other Treatment Tracking form
timeFrame: Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
measure: Additional screen for sleep apnea
timeFrame: Baseline Only
measure: Brief Pain Inventory (Short Form)
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
measure: Clinic Staff Qualitative Assessment
timeFrame: One time at the convenience of clinic staff
measure: Client Behavior Change Interview
timeFrame: One time following the completion of the first post-treatment assessment
measure: Salivary Cytokine Assay
timeFrame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
measure: Credibility Evaluation Questionnaire (CEQ)
timeFrame: Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
measure: Patient Recall Task
timeFrame: Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
measure: Patient Learning Task (Application and Thoughts subsections)
timeFrame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
measure: Useful and Utilized Questionnaire
timeFrame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
measure: Treatment Adherence Rating Scale-Therapist Version
timeFrame: After each treatment session filled out by therapist (8 times)
measure: Body weight
timeFrame: Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
measure: Height
timeFrame: Pre-treatment
Locations:
city: Oakland
country: United States
facility: Alameda Country Behavioral Health Care Services
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison G Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.