Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Outcomes

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    576
  • sponsor
    University of California, Berkeley
Updated on 4 October 2022
sleep disturbances
mental illness
sleep problem

Summary

The sleep disturbance commonly experienced by individuals with a severe mental illness (SMI) reduces these individuals' capacity to function and contributes to key symptoms. This study will test the effects of a sleep treatment that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers (CMHCs), relative to the standard treatment. The investigators will also determine if the adapted and standard versions can improve sleep, improve functioning and reduce symptoms.

Description

An obstacle to the roll-out of evidence-based treatments (EBTs) for severe mental illness (SMI) is that the context for the implementation typically differs from the original testing context causing a lack of "fit" between the setting and the EBT. The investigators propose to evaluate if adapting a specific treatment to improve the contextual fit improves outcomes in a setting that typifies this challenge-community mental health centers (CMHCs).

Following the Experimental Therapeutics Approach, the target is sleep and circadian dysfunction. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts the 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. Hence, the investigators developed the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to treat a wide range of sleep and circadian problems experienced in SMI.

With NIMH support, including a study in CMHCs, the investigators established that TranS-C engages the target. Yet gaps remain: 1) Thus far, the TranS-C providers have been employed, trained and supervised by the university. The investigators will determine if TranS-C can be effectively delivered by providers within CMHCs. 2) The investigators will test a version of TranS-C that has been adapted to improve the fit and to address potential barriers to scaling TranS-C. The rigorous adaptation process used theory, data and stakeholder inputs. 3) The investigators will study ad hoc adaptations made by providers to TranS-C. 4) The investigators include two stages; namely, the Implementation Phase (2 years) and the Sustainment Phase (1 year). The latter responds to urgent calls to study the sustainability of EBTs.

Guided by the Replicating Effective Programs (REP) framework, in this Hybrid Type 1, 4-year study, 8 CMHC clinic sites will be cluster randomized to either Standard or Adapted TranS-C. Then, within each CMHC site, patients will be randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). A total of 104 providers and 624 patients. Patients will be assessed pre, mid and post-treatment and at 6 months follow-up. UC Berkeley will co-ordinate the research, facilitate implementation, collect data etc. Providers within an established network of CMHCs will implement TranS-C. SA1 is to confirm that both Standard vs. Adapted TranS-C, compared to UC-DT, improve sleep and circadian functioning and reduce functional impairment and disorder-focused psychiatric symptoms. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C via provider ratings of acceptability, appropriateness and feasibility. SA3 will examine if better fit, operationalized via provider ratings of acceptability, mediates the relationship between treatment condition and patient outcome. This research will determine if sleep and circadian problems can be effectively addressed in SMI in CMHC settings, test two variations of TranS-C that each have unique advantages and focus on community providers and typical community patients.

Details
Condition Sleep Disorder, Circadian Dysregulation
Treatment Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Usual Care Delayed Treatment
Clinical Study IdentifierNCT04154631
SponsorUniversity of California, Berkeley
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The inclusion criteria for CMHCs are
Publicly funded adult mental health outpatient services
Support from CMHC leadership
The inclusion criteria for CMHC providers are
Employed to deliver clinical services within the CMHC
Interest in learning and delivering TranS-C
Volunteer to participate and formally consent to participate
Consumers must meet the following inclusion criteria
Aged 18 years and older
Meet criteria for a SMI as documented in the CMHC medical record
Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions
Receiving the standard of care for the SMI within the CMHC and consent to regular communications with the consumer's mental health providers
Consent to access their medical record and participate in assessments
Guaranteed place to sleep for at least 2 months that is not a shelter

Exclusion Criteria

Presence of an active and progressive physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction, or making participation in the study unfeasible based on confirmation from the treating clinician and/or medical record
Presence of substance abuse/dependence only if it makes participation in the study unfeasible
Current active intent or plan to commit suicide (those with suicidal ideation are eligible) or homicide risk
Night shift work >2 nights per week in the past 3 months
Pregnancy or breast-feeding
Clear my responses

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