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

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ClinicalTrials.gov Identifier: NCT04154631
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Berkeley

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Disorder Circadian Dysregulation Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) Other: Usual Care Delayed Treatment Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CMHC sites will be cluster randomized to either Standard TranS-C or Adapted TranS-C. Then within each CMHC site, patients will be randomized to either TranS-C or to Usual Care followed by Delayed Treatment (UC-DT).
Masking: Single (Outcomes Assessor)
Masking Description: The assessment team will be blind to group allocation
Primary Purpose: Health Services Research
Official Title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Standard TranS-C
Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation.
Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted.

Experimental: Adapted TranS-C
The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions.
Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.

Active Comparator: UC-DT
Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).
Other: Usual Care Delayed Treatment
Usual care in the partner CMHCs typically starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).




Primary Outcome Measures :
  1. Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance [ Time Frame: Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).

  2. Provider-level outcome: Acceptability Intervention Measure [ Time Frame: Once at baseline, at mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. ]
    Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.


Secondary Outcome Measures :
  1. Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment [ Time Frame: Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).

  2. Patient-level outcome: Composite Sleep Health Score [ Time Frame: Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time).

  3. Patient-level outcome: Midpoint of Sleep Measure [ Time Frame: Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time.

  4. Patient-level outcome: Sheehan Disability Scale [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment.

  5. Patient-level outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses disorder-focused psychiatric symptoms using a self-report questionnaire. Each item on the measure is rated on a 5-point scale (from 0-4), where higher scores indicate a higher frequency of psychiatric symptoms (worse outcome).

  6. Provider-level outcome: Intervention Appropriateness Measure [ Time Frame: Once at baseline, at mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. ]
    Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire

  7. Provider-level outcome: Feasibility of Intervention Measure [ Time Frame: Once at baseline, at mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. ]
    Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire.


Other Outcome Measures:
  1. Patient-level outcome: Alcohol Intake [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire.

  2. Patient-level outcome: Substances Intake [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses past 30-day frequency of substance use using a self-report questionnaire.

  3. Patient-level outcome: Tobacco Intake [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire.

  4. Patient-level outcome: Caffeine Intake [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire.

  5. Patient-level outcome: Suicidal Ideation Questionnaire [ Time Frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. ]
    Assesses past 30-day suicidal ideation using a self-report questionnaire.

  6. Patient-level outcome: Credibility Expectancy Questionnaire [ Time Frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. ]
    Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items.

  7. Patient-level outcome: Utilization Questionnaire [ Time Frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment, and at 6-month follow-up. ]
    Measures the elements of TranS-C that are most used.

  8. Patient-level outcome: Duke Checklist of Medical Conditions & Symptoms [ Time Frame: Once at baseline. ]
    Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.

  9. Provider-level outcome: Checklist of Modules Delivered [ Time Frame: Once at each session between patient and provider. ]
    Assesses which treatment modules were delivered by the providers using a self-report checklist.

  10. Provider-level outcome: Adaptations to Evidence-Based Practices Scale [ Time Frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. ]
    Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire.

  11. Provider-level outcome: Semi-structured interview [ Time Frame: 20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase. ]
    Assesses perceptions of TranS-C.

  12. Provider-level outcome: Use of TranS-C Assessment [ Time Frame: Twice during the 1 year sustainment phase (at 6 months and 12 months). ]
    Assesses if providers continue to use TranS-C in a self-report questionnaire.

  13. Provider-level outcome: Session attendance and duration log [ Time Frame: Once at each session between patient and provider. ]
    Collect session date and duration (length of session).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154631


Contacts
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Contact: Krista Fisher, BA (510) 643-3797 krista_fisher@berkeley.edu
Contact: Marlen Diaz, BA (510) 643-3797 marlen.diaz@berkeley.edu

Locations
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United States, California
Contra Costa Health, Housing, and Homeless Services Division Recruiting
Concord, California, United States, 94520
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Solano County Department of Health & Social Services, Behavioral Health Services Recruiting
Fairfield, California, United States, 94533
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Santa Barbara County Department of Behavioral Wellness Recruiting
Goleta, California, United States, 93110
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Alameda County Behavioral Health Care Services Recruiting
Oakland, California, United States, 94606
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Placer County Health and Human Services, Adult System of Care Recruiting
Roseville, California, United States, 95678
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Monterey County Behavioral Health Recruiting
Salinas, California, United States, 93906
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Bay Area Community Health Recruiting
San Jose, California, United States, 95148
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
County of Santa Cruz Behavioral Health Services for Children and Adults Recruiting
Santa Cruz, California, United States, 95060
Contact: Emma Agnew, MSW    510-643-3797    emmagnew@berkeley.edu   
Sponsors and Collaborators
University of California, Berkeley
Investigators
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Principal Investigator: Allison Harvey, PhD University of California, Berkeley
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Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT04154631    
Other Study ID Numbers: R01MH120147 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Chronobiology Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders