Trial Outcomes & Findings for Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes (NCT NCT04154631)

Last Updated: 2025-10-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

489 participants

Primary outcome timeframe

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.

Results posted on

2025-10-27

Participant Flow

Unit of analysis: CMHC Sites

Participant milestones

Participant milestones
Measure	Standard TranS-C Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation.	Adapted 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 Community Mental Health Center (CMHC) context.
Overall Study STARTED	175 5	314 5
Overall Study Providers	30 5	63 5
Overall Study Patients - Immediate TranS-C	74 5	124 5
Overall Study Patients - UC-DT	71 5	127 5
Overall Study COMPLETED	133 5	261 5
Overall Study NOT COMPLETED	42 0	53 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard TranS-C Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation.	Adapted 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 Community Mental Health Center (CMHC) context.
Overall Study Patients lost to post or 6-month follow-up	42	53

Baseline Characteristics

Age for patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard TranS-C (Immediate) n=74 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=124 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) n=71 Participants 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). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) n=127 Participants 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). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Standard TranS-C (Immediate) - Providers n=30 Participants 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. These data reflect the characteristics of providers who delivered Standard TranS-C.	Adapted TranS-C (Immediate) - Providers n=63 Participants 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. These data reflect the characteristics of providers who delivered Adapted TranS-C.	Total n=489 Participants Total of all reporting groups
Age, Continuous	38.84 years STANDARD_DEVIATION 13.56 • n=74 Participants • Age for patients.	42.42 years STANDARD_DEVIATION 16.36 • n=124 Participants • Age for patients.	45.21 years STANDARD_DEVIATION 16.88 • n=71 Participants • Age for patients.	42.90 years STANDARD_DEVIATION 15.39 • n=127 Participants • Age for patients.	38.26 years STANDARD_DEVIATION 10.06 • n=30 Participants • Age for providers.	41.54 years STANDARD_DEVIATION 11.38 • n=63 Participants • Age for providers.	40.51 years STANDARD_DEVIATION 11.02 • n=93 Participants • Age for providers.
Sex/Gender, Customized Female	42 Participants n=74 Participants	83 Participants n=124 Participants	43 Participants n=71 Participants	74 Participants n=127 Participants	23 Participants n=30 Participants	47 Participants n=63 Participants	312 Participants n=489 Participants
Sex/Gender, Customized Male	31 Participants n=74 Participants	41 Participants n=124 Participants	27 Participants n=71 Participants	52 Participants n=127 Participants	5 Participants n=30 Participants	5 Participants n=63 Participants	161 Participants n=489 Participants
Sex/Gender, Customized Other/category not listed	0 Participants n=74 Participants	0 Participants n=124 Participants	0 Participants n=71 Participants	0 Participants n=127 Participants	0 Participants n=30 Participants	1 Participants n=63 Participants	1 Participants n=489 Participants
Sex/Gender, Customized Missing/declined to answer	1 Participants n=74 Participants	0 Participants n=124 Participants	1 Participants n=71 Participants	1 Participants n=127 Participants	2 Participants n=30 Participants	10 Participants n=63 Participants	15 Participants n=489 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=74 Participants	44 Participants n=124 Participants	29 Participants n=71 Participants	46 Participants n=127 Participants	9 Participants n=30 Participants	17 Participants n=63 Participants	167 Participants n=489 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=74 Participants	79 Participants n=124 Participants	40 Participants n=71 Participants	80 Participants n=127 Participants	15 Participants n=30 Participants	33 Participants n=63 Participants	298 Participants n=489 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=74 Participants	1 Participants n=124 Participants	2 Participants n=71 Participants	1 Participants n=127 Participants	6 Participants n=30 Participants	13 Participants n=63 Participants	24 Participants n=489 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=74 Participants	13 Participants n=124 Participants	5 Participants n=71 Participants	13 Participants n=127 Participants	0 Participants n=30 Participants	2 Participants n=63 Participants	42 Participants n=489 Participants
Race (NIH/OMB) Asian	7 Participants n=74 Participants	7 Participants n=124 Participants	8 Participants n=71 Participants	14 Participants n=127 Participants	3 Participants n=30 Participants	7 Participants n=63 Participants	46 Participants n=489 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=74 Participants	2 Participants n=124 Participants	2 Participants n=71 Participants	1 Participants n=127 Participants	0 Participants n=30 Participants	2 Participants n=63 Participants	10 Participants n=489 Participants
Race (NIH/OMB) Black or African American	5 Participants n=74 Participants	13 Participants n=124 Participants	5 Participants n=71 Participants	14 Participants n=127 Participants	2 Participants n=30 Participants	1 Participants n=63 Participants	40 Participants n=489 Participants
Race (NIH/OMB) White	40 Participants n=74 Participants	68 Participants n=124 Participants	39 Participants n=71 Participants	62 Participants n=127 Participants	19 Participants n=30 Participants	32 Participants n=63 Participants	260 Participants n=489 Participants
Race (NIH/OMB) More than one race	4 Participants n=74 Participants	6 Participants n=124 Participants	3 Participants n=71 Participants	12 Participants n=127 Participants	1 Participants n=30 Participants	5 Participants n=63 Participants	31 Participants n=489 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=74 Participants	15 Participants n=124 Participants	9 Participants n=71 Participants	11 Participants n=127 Participants	5 Participants n=30 Participants	14 Participants n=63 Participants	60 Participants n=489 Participants
Region of Enrollment United States	74 Participants n=74 Participants	124 Participants n=124 Participants	71 Participants n=71 Participants	127 Participants n=127 Participants	30 Participants n=30 Participants	63 Participants n=63 Participants	489 Participants n=489 Participants
Education High school graduate or below	21 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	40 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	23 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	34 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	118 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Education Some or completed college or vocational school	50 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	73 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	43 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	80 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	246 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Education Some or completed graduate school	1 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	10 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	13 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	28 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Education Other/category not listed	0 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	1 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Education Missing/declined to answer	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	3 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Employment Full-time	11 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	16 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	13 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	19 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	59 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Employment Part-time	12 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	26 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	10 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	17 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	65 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Employment Not employed	46 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	78 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	45 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	81 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	250 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Employment Other/category not listed	3 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	10 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	20 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Employment Missing/declined to answer	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	2 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Civil Status Partnered	12 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	19 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	14 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	19 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	64 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Civil Status Unpartnered	60 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	105 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	57 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	106 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	328 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Civil Status Other/category not listed	0 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	2 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Civil Status Missing/declined to answer	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	2 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement Alone	9 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	31 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	15 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	23 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	78 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement With family	49 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	66 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	39 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	66 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	220 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement With friend or roommate or With friend or roommate or pet	11 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	17 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	15 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	21 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	64 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement Supportive housing	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	6 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	11 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	20 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement Other/category not listed	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	5 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	12 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement Missing/declined to answer	1 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	2 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Unemployment	6 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	9 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	21 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Medicare	7 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	22 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	12 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	20 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	61 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Medicaid	28 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	41 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	14 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	46 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	129 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Social Security	8 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	22 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	10 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	15 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	55 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Food Stamps	25 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	34 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	22 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	34 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	115 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Supplemental Security Income/Social Security Disability Insurance	9 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	32 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	17 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	27 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	85 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Supplemental Nutrition Assistance Program	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	14 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	23 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance None	0 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	6 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Other/category not listed	7 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	21 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	8 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	30 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	66 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance Missing/declined to answer	20 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	29 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	17 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	21 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	87 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income <$10,000	10 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	23 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	9 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	30 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	72 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income $10,000-$20,000	16 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	31 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	19 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	21 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	87 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income $20,000-$30,000	11 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	10 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	15 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	38 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income $30,00-$40,000	4 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	6 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	5 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	9 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	24 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income $40,000-$50,000	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	6 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	13 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income >= $50,000	6 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	18 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	11 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	17 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	52 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income I don't know my income	24 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	28 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	23 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	29 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	104 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income Missing/declined to answer	1 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	6 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Neurodevelopmental disorders	8 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	9 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	8 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	11 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	36 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Psychosis	23 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	40 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	22 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	45 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	130 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Bipolar Disorder	22 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	29 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	9 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	33 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	93 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Major Depressive Disorder	43 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	54 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	37 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	51 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	185 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Anxiety disorders	38 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	73 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	42 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	66 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	219 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Obsessive-compulsive and related disorders	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	6 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	4 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	16 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Trauma and stressor-related disorders	23 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	34 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	14 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	36 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	107 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Dissociative disorders	1 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	6 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Personality disorders	3 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	7 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	14 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Feeding and eating disorders	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	0 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	4 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Substance-related and addictive disorders	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	2 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	6 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Other/category not listed	2 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	1 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	3 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	9 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis Missing/declined to answer	1 Participants n=74 Participants • Data not collected for this Baseline Measure from providers.	9 Participants n=124 Participants • Data not collected for this Baseline Measure from providers.	7 Participants n=71 Participants • Data not collected for this Baseline Measure from providers.	10 Participants n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	27 Participants n=396 Participants • Data not collected for this Baseline Measure from providers.
Education	13.59 years STANDARD_DEVIATION 2.87 • n=74 Participants • Data not collected for this Baseline Measure from providers.	13.87 years STANDARD_DEVIATION 3.35 • n=124 Participants • Data not collected for this Baseline Measure from providers.	13.36 years STANDARD_DEVIATION 2.96 • n=71 Participants • Data not collected for this Baseline Measure from providers.	14.97 years STANDARD_DEVIATION 3.72 • n=127 Participants • Data not collected for this Baseline Measure from providers.	—	—	14.08 years STANDARD_DEVIATION 3.37 • n=396 Participants • Data not collected for this Baseline Measure from providers.
Degree Type Marriage and Family Therapy	—	—	—	—	10 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	13 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	23 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Psychology	—	—	—	—	3 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	7 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	10 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Social Work	—	—	—	—	8 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	20 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	28 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Nursing	—	—	—	—	0 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	1 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	1 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Medical	—	—	—	—	1 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	0 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	1 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Occupational Therapy	—	—	—	—	0 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	5 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	5 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Other/category not listed	—	—	—	—	4 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	5 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	9 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Degree Type Missing/declined to answer	—	—	—	—	4 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	12 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	16 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Client Centered	—	—	—	—	19 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	40 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	59 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Family Systems	—	—	—	—	5 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	15 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	20 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Cognitive Behavioral Therapy	—	—	—	—	21 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	30 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	51 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Psychodynamic	—	—	—	—	7 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	11 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	18 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Humanistic	—	—	—	—	2 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	0 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	2 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Integrative/Holistic	—	—	—	—	1 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	3 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	4 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach None	—	—	—	—	0 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	3 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	3 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach Missing/declined to answer	—	—	—	—	3 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	13 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	16 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Licensure Licensed	—	—	—	—	16 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	32 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	48 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Licensure Not Licensed	—	—	—	—	11 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	20 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	31 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Licensure Missing/declined to answer	—	—	—	—	3 Participants n=30 Participants • Data not collected for this Baseline Measure from patients.	11 Participants n=63 Participants • Data not collected for this Baseline Measure from patients.	14 Participants n=93 Participants • Data not collected for this Baseline Measure from patients.
Caseload	—	—	—	—	40.09 number of patients STANDARD_DEVIATION 23.97 • n=30 Participants • Data not collected for this Baseline Measure from patients.	29.59 number of patients STANDARD_DEVIATION 31.62 • n=63 Participants • Data not collected for this Baseline Measure from patients.	33.31 number of patients STANDARD_DEVIATION 29.37 • n=93 Participants • Data not collected for this Baseline Measure from patients.
Employment Duration	—	—	—	—	3.87 years STANDARD_DEVIATION 9.44 • n=30 Participants • Data not collected for this Baseline Measure from patients.	3.84 years STANDARD_DEVIATION 3.96 • n=63 Participants • Data not collected for this Baseline Measure from patients.	3.85 years STANDARD_DEVIATION 3.78 • n=93 Participants • Data not collected for this Baseline Measure from patients.
Years Since Degree Earned	—	—	—	—	9.44 years STANDARD_DEVIATION 7.66 • n=30 Participants • Data not collected for this Baseline Measure from patients.	9.62 years STANDARD_DEVIATION 7.40 • n=63 Participants • Data not collected for this Baseline Measure from patients.	9.56 years STANDARD_DEVIATION 7.43 • n=93 Participants • Data not collected for this Baseline Measure from patients.

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=74 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=124 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) n=71 Participants 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). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) n=127 Participants 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). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Baseline	63.86 T-score Standard Error 7.04	62.10 T-score Standard Error 7.17	62.81 T-score Standard Error 7.36	62.80 T-score Standard Error 8.20	62.76 T-score Standard Error 7.15	62.80 T-score Standard Error 7.89
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Mid-treatment	53.60 T-score Standard Error 9.21	54.00 T-score Standard Error 8.72	—	—	53.87 T-score Standard Error 8.84	—
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Post-treatment	52.31 T-score Standard Error 10.22	50.36 T-score Standard Error 10.04	60.91 T-score Standard Error 8.50	62.11 T-score Standard Error 8.23	50.83 T-score Standard Error 10.07	61.65 T-score Standard Error 8.33
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance 6-month follow-up	54.65 T-score Standard Error 9.59	53.87 T-score Standard Error 11.03	—	—	54.11 T-score Standard Error 10.58	—

PRIMARY outcome

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=30 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=63 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Provider-level Outcome: Acceptability Intervention Measure Baseline	4.69 score on a scale Standard Deviation 0.41	4.70 score on a scale Standard Deviation 0.46	—	—	—	—
Provider-level Outcome: Acceptability Intervention Measure Mid-treatment	4.70 score on a scale Standard Deviation 0.49	4.60 score on a scale Standard Deviation 0.49	—	—	—	—
Provider-level Outcome: Acceptability Intervention Measure Post-treatment	4.64 score on a scale Standard Deviation 0.63	4.67 score on a scale Standard Deviation 0.53	—	—	—	—

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=74 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=124 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) n=71 Participants 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). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) n=127 Participants 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). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment 6-month follow-up	57.40 T-score Standard Deviation 10.57	53.88 T-score Standard Deviation 11.68	—	—	54.99 T-score Standard Deviation 11.42	—
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment Baseline	62.78 T-score Standard Deviation 9.21	61.62 T-score Standard Deviation 8.59	60.79 T-score Standard Deviation 8.88	62.69 T-score Standard Deviation 7.53	62.06 T-score Standard Deviation 8.82	62.01 T-score Standard Deviation 8.07
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment Mid-treatment	57.01 T-score Standard Deviation 10.06	55.05 T-score Standard Deviation 10.62	—	—	55.69 T-score Standard Deviation 10.43	—
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment Post-treatment	54.21 T-score Standard Deviation 9.45	51.03 T-score Standard Deviation 10.60	60.27 T-score Standard Deviation 8.11	61.73 T-score Standard Deviation 8.59	51.78 T-score Standard Deviation 10.38	61.17 T-score Standard Deviation 8.42

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=74 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=124 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) n=71 Participants 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). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) n=127 Participants 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). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Patient-level Outcome: Composite Sleep Health Score Baseline	1.80 score on a scale Standard Deviation 1.42	2.11 score on a scale Standard Deviation 1.47	1.95 score on a scale Standard Deviation 1.35	2.14 score on a scale Standard Deviation 1.33	1.99 score on a scale Standard Deviation 1.46	2.07 score on a scale Standard Deviation 1.33
Patient-level Outcome: Composite Sleep Health Score Mid-treatment	3.41 score on a scale Standard Deviation 1.43	3.34 score on a scale Standard Deviation 1.51	—	—	3.36 score on a scale Standard Deviation 1.48	—
Patient-level Outcome: Composite Sleep Health Score Post-treatment	3.76 score on a scale Standard Deviation 1.59	3.47 score on a scale Standard Deviation 1.55	2.05 score on a scale Standard Deviation 1.49	2.33 score on a scale Standard Deviation 1.48	3.54 score on a scale Standard Deviation 1.55	2.22 score on a scale Standard Deviation 1.49
Patient-level Outcome: Composite Sleep Health Score 6-month follow-up	3.18 score on a scale Standard Deviation 1.63	3.36 score on a scale Standard Deviation 1.51	—	—	3.30 score on a scale Standard Deviation 1.54	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=74 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=124 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) n=71 Participants 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). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) n=127 Participants 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). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Patient-level Outcome: Sheehan Disability Scale Baseline	12.26 score on a scale Standard Deviation 7.97	12.85 score on a scale Standard Deviation 7.04	12.24 score on a scale Standard Deviation 7.04	13.65 score on a scale Standard Deviation 6.51	12.63 score on a scale Standard Deviation 7.38	13.15 score on a scale Standard Deviation 6.72
Patient-level Outcome: Sheehan Disability Scale Post-Treatment	8.08 score on a scale Standard Deviation 6.38	5.97 score on a scale Standard Deviation 5.90	12.59 score on a scale Standard Deviation 7.37	12.19 score on a scale Standard Deviation 7.08	6.49 score on a scale Standard Deviation 6.06	12.32 score on a scale Standard Deviation 7.17
Patient-level Outcome: Sheehan Disability Scale 6-month follow-up	9.09 score on a scale Standard Deviation 7.62	8.78 score on a scale Standard Deviation 7.85	—	—	8.88 score on a scale Standard Deviation 7.75	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=74 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=124 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) n=71 Participants 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). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) n=127 Participants 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). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT n=198 Participants Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure Baseline	24.58 score on a scale Standard Deviation 8.47	24.12 score on a scale Standard Deviation 9.29	24.31 score on a scale Standard Deviation 10.33	24.11 score on a scale Standard Deviation 8.93	24.30 score on a scale Standard Deviation 8.97	24.18 score on a scale Standard Deviation 9.43
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure Post-treatment	20.33 score on a scale Standard Deviation 9.78	18.44 score on a scale Standard Deviation 10.88	22.90 score on a scale Standard Deviation 10.19	23.62 score on a scale Standard Deviation 7.90	18.88 score on a scale Standard Deviation 10.62	23.35 score on a scale Standard Deviation 8.82
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure 6-month follow-up	19.53 score on a scale Standard Deviation 9.71	19.33 score on a scale Standard Deviation 10.09	—	—	19.39 score on a scale Standard Deviation 9.94	—

SECONDARY outcome

Population: Intervention Appropriateness Measure was collected only from providers.Provider perceptions of appropriateness 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.

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=30 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=63 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Provider-level Outcome: Intervention Appropriateness Measure Baseline	4.62 score on a scale Standard Deviation 0.50	4.69 score on a scale Standard Deviation 0.46	—	—	—	—
Provider-level Outcome: Intervention Appropriateness Measure Mid-treatment	4.70 score on a scale Standard Deviation 0.55	4.47 score on a scale Standard Deviation 0.57	—	—	—	—
Provider-level Outcome: Intervention Appropriateness Measure Post-treatment	4.59 score on a scale Standard Deviation 0.69	4.59 score on a scale Standard Deviation 0.54	—	—	—	—

SECONDARY outcome

Population: Feasibility of Intervention Measure was collected only from providers. Provider perceptions of feasibility 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.

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.

Outcome measures

Outcome measures
Measure	Standard TranS-C (Immediate) n=30 Participants 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. 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. Participants in this group received Standard TranS-C immediately.	Adapted TranS-C (Immediate) n=63 Participants 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. 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. Participants in this group received Adapted TranS-C immediately.	Standard TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Standard TranS-C.	Adapted TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C.	Immediate TranS-C Standard and Adapted TranS-C combined for participants randomized to the immediate condition.	UC-DT Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Provider-level Outcome: Feasibility of Intervention Measure Baseline	4.63 score on a scale Standard Deviation 0.46	4.61 score on a scale Standard Deviation 0.48	—	—	—	—
Provider-level Outcome: Feasibility of Intervention Measure Mid-treatment	4.64 score on a scale Standard Deviation 0.59	4.51 score on a scale Standard Deviation 0.58	—	—	—	—
Provider-level Outcome: Feasibility of Intervention Measure Post-treatment	4.61 score on a scale Standard Deviation 0.74	4.61 score on a scale Standard Deviation 0.52	—	—	—	—

Other adverse events

Adverse event data not reported

Additional Information

Professor of Clinical Psychology

Department of Psychology, University of California, Berkeley

Phone: 5104736490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place