Sleep DisorderNCT04154631

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

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 10 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: 489 participants
Where: 10 sitesUnited States
Study dates: 8 Jan 2020to 19 Dec 2023
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 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

Show all 14Show fewer

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

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 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
Santa Barbara County Department of Behavioral Wellness
Goleta, California, 93110
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 1: Implementation

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.

Read the detailed 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.

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 NCT04154631
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 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 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), 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 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), 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 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), 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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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.

8 Jan 202019 Dec 2023

First posted6 Nov 2019
Study start8 Jan 2020
Primary completion19 Dec 2023
Study completion19 Dec 2023

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 (6)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: 489 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04154631
Sponsor's protocol ID: R01MH120147
Status last verified: Oct 2025
First submitted: 28 Oct 2019
Last updated: 27 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Diaz M, Milner AE, Sarfan LD, Agnew ER, Oliver SM, Bol K, Harvey AG. Do Provider Characteristics and Perceptions Influence the Adoption and Implementation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health Centers? Community Ment Health J. 2026 May;62(4):619-631. doi: 10.1007/s10597-025-01552-y. Epub 2025 Oct 31.
PubMed 41171520
Callaway CA, Varghese JM, Agnew ER, Sarfan LD, Harvey AG. An Examination of Training Quality and Provider Outcomes Across Two Generations of Train-the-Trainer. Adm Policy Ment Health. 2025 Sep;52(5):966-982. doi: 10.1007/s10488-025-01463-w. Epub 2025 Aug 21.
PubMed 40839336
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 AG, Agnew ER, Esteva Hache R, Spencer JM, Diaz M, Ovalle Patino E, Milner A, Dong L, Kilbourne AM, Buysse DJ, Callaway CA, Sarfan LD. A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the "fit" of psychological treatments by adapting to context. Implement Sci. 2025 Jul 9;20(1):32. doi: 10.1186/s13012-025-01440-9.
PubMed 40634991
Sarfan LD, Bajwa Z, Diaz M, Tiab S, Fisher K, Agnew ER, Howlett SA, Oliver S, Callaway CA, Harvey AG. "So Many Other Things Improve" with Transdiagnostic Treatment for Sleep and Circadian Problems: Interviews with Community Providers on Treating Clients with Serious Mental Illness. Adm Policy Ment Health. 2025 Mar;52(2):318-330. doi: 10.1007/s10488-024-01410-1. Epub 2024 Sep 9.
PubMed 39249560
Sarfan LD, Agnew ER, Diaz M, Dong L, Fisher K, Spencer JM, Howlett SA, Hache RE, Callaway CA, 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 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2023 Mar 17;24(1):198. doi: 10.1186/s13063-023-07148-9.
PubMed 36927461

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 27 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 1: Implementation
ClinicalTrials.gov ID: NCT04154631
Acronym / sponsor ID: R01MH120147
Conditions: Sleep Disorder, Circadian Dysregulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 489 participants (actual)
Lead sponsor: University of California, BerkeleyUniversity, hospital or other
Study start: 8 Jan 2020 (actual)
Primary completion: 19 Dec 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 6 Nov 2019 (actual)
Results: Posted 4 Jul 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 (14 listed)

Publicly funded adult mental health outpatient services
Support from CMHC leadership
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

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 Disturbance
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), 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 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), and 6-month follow-up.
Patient-level Outcome: Composite Sleep Health Score
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), and 6-month follow-up.
Patient-level Outcome: Sheehan Disability Scale
Time frame: Baseline, post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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 4 Jul 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	175	133
Adapted TranS-C	314	261

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

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), and 6-month follow-up.. Mean (Standard Error). Unit: T-score

Measure	Standard TranS-C (Immediate) n = 74	Adapted TranS-C (Immediate) n = 124	Standard TranS-C (UC-DT) n = 71	Adapted TranS-C (UC-DT) n = 127	Immediate TranS-C n = 198	UC-DT n = 198
Baseline	63.86 (7.04)	62.10 (7.17)	62.81 (7.36)	62.80 (8.20)	62.76 (7.15)	62.80 (7.89)
Mid-treatment	53.60 (9.21)	54.00 (8.72)	–	–	53.87 (8.84)	–
Post-treatment	52.31 (10.22)	50.36 (10.04)	60.91 (8.50)	62.11 (8.23)	50.83 (10.07)	61.65 (8.33)
6-month follow-up	54.65 (9.59)	53.87 (11.03)	–	–	54.11 (10.58)	–

Immediate TranS-C vs UC-DT: Time by treatment interaction coeff.: -10.91, p <0.001, Intent-to-treat, multilevel modeling
Standard TranS-C (Immediate) vs Adapted TranS-C (Immediate): Coefficient of indirect effect: 0.17 (95% CI -4.62 to 4.95), p = 0.95, SEM
Standard TranS-C (Immediate) vs Adapted TranS-C (Immediate): Coefficient of indirect effect: 0.09 (95% CI -2.39 to 2.56), p = 0.95, SEM

Population analysed: Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT).

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 (Immediate) - Providers n = 30	Adapted TranS-C (Immediate) - Providers n = 63
Baseline	4.69 (0.41)	4.70 (0.46)
Mid-treatment	4.70 (0.49)	4.60 (0.49)
Post-treatment	4.64 (0.63)	4.67 (0.53)

Standard TranS-C (Immediate) - Providers vs Adapted TranS-C (Immediate) - Providers: time by treatment interaction coeff.: -0.03, p = 0.77, Intent-to-treat, multilevel modeling

Population analysed: Acceptability Intervention Measure was collected only from providers. Provider perceptions of acceptability were analyzed only for providers who had treated at least one patient in the immediate TranS-C condition. Data from providers who had treated patients in the delayed TranS-C condition were not reported due to substantial overlap with those in the immediate group. As a result, we present Standard and Adapted data exclusively for the immediate TranS-C condition.

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 74 (0%)	0 of 74 (0%)	0 of 74
Adapted TranS-C (Immediate)	0 of 124 (0%)	0 of 124 (0%)	0 of 124
Standard TranS-C (UC-DT)	0 of 71 (0%)	0 of 71 (0%)	0 of 71
Adapted TranS-C (UC-DT)	0 of 127 (0%)	0 of 127 (0%)	0 of 127
Standard TranS-C (Immediate) - Providers	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Adapted TranS-C (Immediate) - Providers	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41171520Diaz M, Milner AE, Sarfan LD, Agnew ER, Oliver SM, Bol K, Harvey AG. Do Provider Characteristics and Perceptions Influence the Adoption and Implementation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health Centers? Community Ment Health J. 2026 May;62(4):619-631. doi: 10.1007/s10597-025-01552-y. Epub 2025 Oct 31.
Derived from this study: PubMed 40839336Callaway CA, Varghese JM, Agnew ER, Sarfan LD, Harvey AG. An Examination of Training Quality and Provider Outcomes Across Two Generations of Train-the-Trainer. Adm Policy Ment Health. 2025 Sep;52(5):966-982. doi: 10.1007/s10488-025-01463-w. Epub 2025 Aug 21.
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 40634991Harvey AG, Agnew ER, Esteva Hache R, Spencer JM, Diaz M, Ovalle Patino E, Milner A, Dong L, Kilbourne AM, Buysse DJ, Callaway CA, Sarfan LD. A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the "fit" of psychological treatments by adapting to context. Implement Sci. 2025 Jul 9;20(1):32. doi: 10.1186/s13012-025-01440-9.
Derived from this study: PubMed 39249560Sarfan LD, Bajwa Z, Diaz M, Tiab S, Fisher K, Agnew ER, Howlett SA, Oliver S, Callaway CA, Harvey AG. "So Many Other Things Improve" with Transdiagnostic Treatment for Sleep and Circadian Problems: Interviews with Community Providers on Treating Clients with Serious Mental Illness. Adm Policy Ment Health. 2025 Mar;52(2):318-330. doi: 10.1007/s10488-024-01410-1. Epub 2024 Sep 9.
Derived from this study: PubMed 36927461Sarfan LD, Agnew ER, Diaz M, Dong L, Fisher K, Spencer JM, Howlett SA, Hache RE, Callaway CA, 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 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2023 Mar 17;24(1):198. doi: 10.1186/s13063-023-07148-9.

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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

10 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 14 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 27 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 10 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 4 Jul 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 Disturbance (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), 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 NCT04154631, which also lists 6 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 27 Oct 2025.