Sleep DisorderNCT05805657

Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer

A study testing Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) and Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Disorder, Circadian Dysregulation
What is being tested?: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) and Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 9 sitesUnited States
Study dates: 14 Dec 2020to 8 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The inclusion criteria for the CMHC local trainers are:
Employed in participating CMHCs
Completed a Generation 1 TranS-C training (i.e., led by UC Berkeley expert trainers)
Volunteer to participate and formally consent to participate
The inclusion criteria for CMHCs are:
Publicly funded adult mental health outpatient services

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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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Contra Costa Health, Housing, and Homeless Services Division
Concord, California, 94520
Solano County Department of Health & Social Services, Behavioral Health Services
Fairfield, California, 94533
Kings County Behavioral Health
Hanford, California, 93230
Lake County Behavioral Health Services
Lucerne, California, 95458
Alameda County Behavioral Health Care Services
Oakland, California, 94606
Placer County Health and Human Services, Adult System of Care
Roseville, California, 95678
Monterey County Behavioral Health
Salinas, California, 93906
Bay Area Community Health
San Jose, California, 95148
County of Santa Cruz Behavioral Health Services for Children and Adults
Santa Cruz, California, 95060

Other trials in United States

About this study

Official title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 2: Train-the-Trainer

The train-the-trainer (TTT) approach is a promising method of sustaining training efforts in community mental health centers (CMHCs). This study will test the implementation and effectiveness outcomes of a sleep treatment delivered by CMHC providers who are trained and supervised within CMHCs via TTT. The investigators will test two versions of the sleep treatment, a "Standard" version and an "Adapted" version that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers.

Read the detailed description

There are significant barriers to widespread implementation and sustainment of evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs), including insufficient time and funding, shortage of trainers and consultants, and staff turnover. The investigators propose to evaluate one possible solution, the train-the-trainer (TTT) approach, in the context of a transdiagnostic EBPT for sleep and circadian dysfunction-the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)- for serious mental illness (SMI) in CMHCs. This entry describes the Train-the-Trainer Phase, the second of a three-phase hybrid type 2 effectiveness-implementation trial conducted to test TranS-C in CMHCs.

TTT is a training structure with multiple levels, called "Generations." First, external expert trainers train an initial cohort of providers in a specific EBPT ("Generation 1 providers"). Next, Generation 1 providers are offered additional training in how to train others in the EBPT and become "local trainers." These local trainers then train the next cohort of providers within their organization ("Generation 2 providers").

The Train-the-Trainer Phase builds upon the first phase, the Implementation Phase (NCT04154631), in which implementation and effectiveness outcomes of two versions of TranS-C, Standard and Adapted are compared, with CMHC providers, who are trained by treatment experts. Adapted TranS-C is a version of TranS-C designed to improve 'fit' with the CMHC context. In the Train-the-Trainer Phase, the aim is to test implementation and effectiveness outcomes of Standard and Adapted TranS-C with CMHC providers who are trained and supervised within CMHCs (i.e., Generation 2 of TTT).

In the Implementation Phase, 10 CMHC clinic sites were cluster randomized to either Standard or Adapted TranS-C. Nine CMHCs continued participation into the Train-the-Trainer Phase. Within each CMHC site, patients are randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). Generation 2 patients (n=130) will be assessed pre, mid and post-treatment and at 6 month follow-up. UC Berkeley will coordinate the research, facilitate implementation, collect data, etc. Generation 2 providers (n=60), trained by local trainers within an established network of CMHCs, will implement TranS-C and will be assessed at pre and post-treatment. 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 for Generation 2 patients. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C via Generation 2 provider ratings of acceptability, appropriateness and feasibility. SA3 will examine if better fit, operationalized via Generation 2 provider ratings of acceptability, mediates the relationship between treatment condition and Generation 2 patient outcome. This research will determine if (1) sleep and circadian problems can be effectively addressed in SMI by CMHC providers trained and supervised within CMHCs via the train-the-trainer approach, (2) test two variations of TranS-C that each have unique advantages and focus on community providers and typical community patients.

Conditions: Sleep Disorder, Circadian Dysregulation
Being tested: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Usual Care Delayed Treatment
Medical subject headings: Sleep Wake Disorders, Chronobiology Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)Behavioural
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)Behavioural
The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.
Usual Care Delayed TreatmentOther
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).

Study groups in NCT05805657
Study group	Role	What they receive
Standard TranS-C	Experimental	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. Receives: Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
Adapted TranS-C	Experimental	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. Receives: Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
UC-DT	Active comparator	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). Receives: Other: Usual Care Delayed Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep disturbance.
Measured: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Provider-level Outcome: Acceptability Intervention Measure
Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability.
Measured: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).

Secondary outcomes (6)

Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment Scale. The 8-item short version scale assesses perceived sleep problems during waking hours (e.g., alertness, sleepiness, tiredness) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.1 to 80.1. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep-related impairment.
Measured: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-level Outcome: Composite Sleep Health Score
Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary < 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours). Each dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.
Measured: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-level Outcome: Sheehan Disability Scale
The Sheehan Disability Scale (SDS) assesses impairment in work/school, social, and family life. Items are rated on a scale from 0 (not at all) to 10 (extremely). Items are summed to produce a single score. Scores range from 0 to 30, with higher scores indicating higher functional impairment.
Measured: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5) assesses psychiatric symptoms across 13 mental health domains. Participants rate on a 5-point scale how often they were bothered by each symptom on a scale from 0 (not at all) to 4 (nearly every day). Scores range from 0 to 52, with higher scores indicating more severe symptoms.
Measured: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Provider-level Outcome: Intervention Appropriateness Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of appropriateness.
Measured: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Provider-level Outcome: Feasibility of Intervention Measure
Assesses provider perceptions of the feasibility of the treatment intervention using a self-report questionnaire. The 4- item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of feasibility.
Measured: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20208 May 2024

First posted10 Apr 2023
Study start14 Dec 2020
Primary completion8 May 2024
Study completion8 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Sleep DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05805657
Sponsor's protocol ID: R01MH120147_P2
Other IDs: R01MH120147
Status last verified: Oct 2025
First submitted: 10 Mar 2023
Last updated: 23 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Harvey AG, Agnew ER, Esteva Hache R, Callaway CA, Ovalle Patino E, Milner A, Spencer JM, Diaz M, Dong L, Kilbourne AM, Buysse DJ, Stice E, Sarfan LD. A randomized trial of adapted versus standard versions the transdiagnostic intervention for sleep and circadian dysfunction (TSC) implemented via facilitation and delivered by community mental health providers using train-the-trainer. Implement Sci. 2025 Nov 29;21(1):5. doi: 10.1186/s13012-025-01467-y.
PubMed 41318500
Horwitz TB, Sarfan LD, Milner AE, Varghese J, Callaway CA, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health: Evaluating Self-Reported Psychiatric Disorders as a Predictor of Symptoms and Treatment Outcome. Res Sq [Preprint]. 2025 Aug 6:rs.3.rs-7189279. doi: 10.21203/rs.3.rs-7189279/v1.
PubMed 40799745
Harvey A, Agnew ER, Hache RE, Callaway CA, Patino EO, Milner A, Spencer JM, Diaz M, Dong L, Kilbourne AM, Buysse DJ, Stice E, Sarfan LD. A randomized trial of Adapted versus Standard versions the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) implemented via facilitation and delivered by community mental health providers using train-the-trainer. Res Sq [Preprint]. 2025 Jul 14:rs.3.rs-6414484. doi: 10.21203/rs.3.rs-6414484/v1.
PubMed 40709255
Callaway CA, Sarfan LD, Agnew ER, Dong L, Spencer JM, Hache RE, Diaz M, Howlett SA, Fisher KR, Yates HEH, Stice E, Kilbourne AM, Buysse DJ, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer. Trials. 2023 Aug 7;24(1):503. doi: 10.1186/s13063-023-07523-6.
PubMed 37550730
Callaway CA, Sarfan LD, Agnew ER, Dong L, Spencer JM, Hache RE, Diaz M, Howlett SA, Fisher KR, Yates HEH, Stice E, Kilbourne AM, Buysse DJ, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: Study protocol for a hybrid type 2 effectiveness-implementation cluster- randomized trial using train-the-trainer. Res Sq [Preprint]. 2023 Jun 17:rs.3.rs-2943787. doi: 10.21203/rs.3.rs-2943787/v1.
PubMed 37398014

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 2: Train-the-Trainer
ClinicalTrials.gov ID: NCT05805657
Acronym / sponsor ID: R01MH120147_P2
Conditions: Sleep Disorder, Circadian Dysregulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: University of California, BerkeleyUniversity, hospital or other
Study start: 14 Dec 2020 (actual)
Primary completion: 8 May 2024 (actual)
Study completion: 8 May 2024 (actual)
First posted: 10 Apr 2023 (actual)
Results: Posted 23 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
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).

Arm	Type	Receives
Standard TranS-C	Experimental	Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (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.
Adapted TranS-C	Experimental	Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (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.
UC-DT	Active comparator	Other: Usual Care Delayed TreatmentUsual 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Employed in participating CMHCs
Completed a Generation 1 TranS-C training (i.e., led by UC Berkeley expert trainers)
Volunteer to participate and formally consent to participate
Publicly funded adult mental health outpatient services
Support from CMHC leadership

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Standard TranS-C
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.	Behavioural	Adapted TranS-C
Usual Care Delayed TreatmentUsual 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).	Other	UC-DT

Primary outcome

Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep disturbance.
Provider-level Outcome: Acceptability Intervention Measure
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability.

6 secondary outcomes

Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-level Outcome: Composite Sleep Health Score
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-level Outcome: Sheehan Disability Scale
Time frame: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
Time frame: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Provider-level Outcome: Intervention Appropriateness Measure
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Provider-level Outcome: Feasibility of Intervention Measure
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).

Results and safety

Results posted to the registry on 23 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard TranS-C	22	10
Adapted TranS-C	174	110

Primary outcome: Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance

Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.. Mean (Standard Deviation). Unit: T-score

Measure	Standard TranS-C (Immediate) n = 8	Adapted TranS-C (Immediate) n = 70	Standard TranS-C (UC-DT) n = 8	Adapted TranS-C (UC-DT) n = 57	Immediate TranS-C n = 78	UC-DT n = 65	Standard TranS-C n = 16	Adapted TranS-C n = 127	TranS-C n = 143
Baseline	66.67 (6.44)	62.21 (7.73)	60.54 (5.63)	62.24 (7.34)	62.71 (7.69)	62.05 (7.14)	63.81 (6.66)	62.23 (7.52)	62.40 (7.42)
Mid-treatment	49.55 (2.33)	53.81 (9.58)	–	–	53.60 (9.39)	–	50.08 (2.65)	55.10 (9.27)	54.80 (9.08)
Post-treatment	51.05 (15.23)	55.06 (10.76)	61.48 (10.37)	61.04 (8.52)	54.74 (11.04)	61.08 (8.59)	54.21 (12.22)	55.21 (11.18)	55.12 (11.19)
6-month follow-up	52.35 (5.83)	52.48 (10.34)	–	–	52.47 (10.07)	–	54.86 (6.74)	53.54 (10.05)	53.63 (9.84)

Immediate TranS-C vs UC-DT: Time by treatment interaction coeff.: -7.16, p <0.001, Intent-to-treat, multilevel modeling
Standard TranS-C vs Adapted TranS-C: Time by treatment interaction coeff.: 2.22, p = 0.52, Intent-to-treat, multilevel modeling
TranS-C: Coefficient: -10.89, p = 0.02, Regression, Linear

Population analysed: Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). To increase the sample size, analyses comparing Standard vs. Adapted TranS-C collapsed over immediate and UC-DT conditions (using the assessments collected after the UC-DT group started TranS-C at mid-treatment, post-treatment, and 6-month follow-up). An additional analysis also collapsed across all conditions.

Primary outcome: Provider-level Outcome: Acceptability Intervention Measure

Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).. Mean (Standard Deviation). Unit: score on a scale

Measure	Standard TranS-C - Providers n = 6	Adapted TranS-C - Providers n = 47	TranS-C - Providers n = 53
Baseline	4.90 (0.22)	4.74 (0.41)	4.76 (0.39)
Mid-treatment	5.00 (0.00)	4.64 (0.44)	4.65 (0.44)
Post-treatment	5.00 (0.00)	4.54 (0.58)	4.56 (0.57)

Population analysed: Acceptability Intervention Measure was collected only from providers. To increase the sample size, and because providers treated patients who could have been in either the immediate or UC-DT conditions, we analyzed by collapsing across immediate and UC-DT for providers. For some analyses, data were collapsed across Standard and Adapted TranS-C. This measure was not assessed following usual care.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard TranS-C (Immediate)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Adapted TranS-C (Immediate)	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Standard TranS-C (UC-DT)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Adapted TranS-C (UC-DT)	0 of 57 (0%)	0 of 57 (0%)	0 of 57
Standard TranS-C - Providers	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Adapted TranS-C - Providers	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41318500Harvey AG, Agnew ER, Esteva Hache R, Callaway CA, Ovalle Patino E, Milner A, Spencer JM, Diaz M, Dong L, Kilbourne AM, Buysse DJ, Stice E, Sarfan LD. A randomized trial of adapted versus standard versions the transdiagnostic intervention for sleep and circadian dysfunction (TSC) implemented via facilitation and delivered by community mental health providers using train-the-trainer. Implement Sci. 2025 Nov 29;21(1):5. doi: 10.1186/s13012-025-01467-y.
Derived from this study: PubMed 40799745Horwitz TB, Sarfan LD, Milner AE, Varghese J, Callaway CA, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health: Evaluating Self-Reported Psychiatric Disorders as a Predictor of Symptoms and Treatment Outcome. Res Sq [Preprint]. 2025 Aug 6:rs.3.rs-7189279. doi: 10.21203/rs.3.rs-7189279/v1.
Derived from this study: PubMed 40709255Harvey A, Agnew ER, Hache RE, Callaway CA, Patino EO, Milner A, Spencer JM, Diaz M, Dong L, Kilbourne AM, Buysse DJ, Stice E, Sarfan LD. A randomized trial of Adapted versus Standard versions the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) implemented via facilitation and delivered by community mental health providers using train-the-trainer. Res Sq [Preprint]. 2025 Jul 14:rs.3.rs-6414484. doi: 10.21203/rs.3.rs-6414484/v1.
Derived from this study: PubMed 37550730Callaway CA, Sarfan LD, Agnew ER, Dong L, Spencer JM, Hache RE, Diaz M, Howlett SA, Fisher KR, Yates HEH, Stice E, Kilbourne AM, Buysse DJ, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer. Trials. 2023 Aug 7;24(1):503. doi: 10.1186/s13063-023-07523-6.
Derived from this study: PubMed 37398014Callaway CA, Sarfan LD, Agnew ER, Dong L, Spencer JM, Hache RE, Diaz M, Howlett SA, Fisher KR, Yates HEH, Stice E, Kilbourne AM, Buysse DJ, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: Study protocol for a hybrid type 2 effectiveness-implementation cluster- randomized trial using train-the-trainer. Res Sq [Preprint]. 2023 Jun 17:rs.3.rs-2943787. doi: 10.21203/rs.3.rs-2943787/v1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Allison Harvey, PhD principal investigator

University of California, Berkeley

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance (time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05805657, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.