Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes

Sleep Disorder Clinical Trial

Official title:

Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 1: Implementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154631
• Other study ID #: R01MH120147
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: Krista Fisher, BA
• Phone: (510) 643-3797
• Email: krista_fisher[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 psychological treatments (EBPTs) 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 EBPT. 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 a Sustainment Phase (1 year), responding to urgent calls to study the sustainability of EBPTs.

This entry describes the Implementation Phase, the first of a three-phase hybrid type 2 effectiveness-implementation trial. In this phase, implementation and effectiveness outcomes of two versions of TranS-C (Standard and Adapted) are compared with CMHC providers who are trained by treatment experts.

Guided by the Replicating Effective Programs (REP) framework, at least 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 96 providers and 576 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 576
• Est. completion date: October 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or able to deliver client-facing services to CMHC clients

• 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 an SMI per self-report and confirmed by referring provider or administration of the Mini International Neuropsychiatric Interview (MINI) (DSM-5, Version 7.0.0) by a licensed clinical social worker on the research team

• 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 and consent to regular communications between the research team and provider

• 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) only if it makes participation in the study unfeasible, or homicide risk

• Night shift work >2 nights per week in the past 3 months

• Pregnancy or breast-feeding

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.
• 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.

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).

Locations

Country	Name	City	State
United States	Contra Costa Health, Housing, and Homeless Services Division	Concord	California
United States	Solano County Department of Health & Social Services, Behavioral Health Services	Fairfield	California
United States	Santa Barbara County Department of Behavioral Wellness	Goleta	California
United States	Kings County Behavioral Health	Hanford	California
United States	Lake County Behavioral Health Services	Lucerne	California
United States	Alameda County Behavioral Health Care Services	Oakland	California
United States	Placer County Health and Human Services, Adult System of Care	Roseville	California
United States	Monterey County Behavioral Health	Salinas	California
United States	Bay Area Community Health	San Jose	California
United States	County of Santa Cruz Behavioral Health Services for Children and Adults	Santa Cruz	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-level outcome: Alcohol Intake	Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Substances Intake	Assesses past 30-day frequency of substance use using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Tobacco Intake	Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Caffeine Intake	Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Suicidal Ideation Questionnaire	Assesses past 30-day suicidal ideation using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Credibility Expectancy Questionnaire	Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items.	Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other	Patient-level outcome: Utilization Questionnaire	Measures the elements of TranS-C that are most used.	Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other	Patient-level outcome: Utilization Questionnaire	Measures the elements of TranS-C that are most used.	Once at 6-month follow-up after treatment ends.
Other	Patient-level outcome: Duke Checklist of Medical Conditions & Symptoms	Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.	Once at baseline.
Other	Provider-level outcome: Checklist of Modules Delivered	Assesses which treatment modules were delivered by the providers using a self-report checklist.	Once at each session between patient and provider.
Other	Provider-level outcome: Adaptations to Evidence-Based Practices Scale	Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire.	Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other	Provider-level outcome: Semi-structured interview	Assesses perceptions of TranS-C.	20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase.
Other	Provider-level outcome: Use of TranS-C Assessment	Assesses if providers continue to use TranS-C in a self-report questionnaire.	Once during the 1 year sustainment phase.
Other	Provider-level outcome: Session attendance and duration log	Collect session date and duration (length of session).	Once at each session between patient and provider.
Other	Provider-level outcome: Training evaluation/knowledge test	Provider evaluation of the training; provider knowledge of content covered in the training; provider willingness and confidence in delivering TranS-C.	Through the first 2.5 years of the study, an average of 4 per month
Other	Provider-level outcome: Gold Standard Training Elements	Extent of gold standard training elements present in each training session, with respect to content and technique.	Through the first 2.5 years of the study, an average of 4 per month
Other	Provider-level outcome: Number of TranS-C Sessions	Number of sessions delivered to each enrolled patient by each provider.	Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment
Other	Facilitator-level outcome: Gold Standard Supervision Elements	Presence of gold-standard supervision elements covered during each supervision session.	Up to 30 months
Other	Facilitator-level outcome: Implementation Log	Weekly record of facilitator activities, amount of time per activity, county, year, type of communication, implementation strategies, target(s), intended outcome(s).	Up to 30 months
Other	Facilitator-level outcome: Meeting Log	Weekly record of community meeting details as applicable, including: county, generation, level of contact (i.e., leadership, providers), type/modality of contact, length of meeting, number of attendees, recording, general description, standardized description, main presenter and role of UCB staff.	Up to 30 months
Primary	Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance	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).	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.
Primary	Provider-level outcome: Acceptability Intervention Measure	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.	Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, and to post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Secondary	Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment	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).	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.
Secondary	Patient-level outcome: Composite Sleep Health Score	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).	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.
Secondary	Patient-level outcome: Midpoint of Sleep Measure	Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time.	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.
Secondary	Patient-level outcome: Sheehan Disability Scale	Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Secondary	Patient-level outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure	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).	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Secondary	Provider-level outcome: Intervention Appropriateness Measure	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire	Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, and to post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Secondary	Provider-level outcome: Feasibility of Intervention Measure	Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire.	Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, and to post-treatment, which is 6 or 10 weeks after the beginning of treatment.