Trial Outcomes & Findings for Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer (NCT NCT05805657)

NCT ID: NCT05805657

Last Updated: 2025-10-23

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

NA

Target enrollment

196 participants

Primary outcome timeframe

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

Results posted on

2025-10-23

Participant Flow

CMHCs (the units) were randomized to "Standard TranS-C" or "Adapted TranS-C" but CMHCs were not further randomized to UC-DT or Immediate TranS-C. Patients within a CMHC were randomized to UC-DT or immediate TranS-C. Therefore, only "Standard TranS-C" and "Adapted TranS-C" are reported in the participant flow so that units (i.e., CMHCS) are not counted more than once across a row.

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
22 3
174 5
Overall Study
Providers
6 3
47 5
Overall Study
Patients - Immediate
8 3
70 5
Overall Study
Patients - UC-DT
8 3
57 5
Overall Study
COMPLETED
10 3
110 5
Overall Study
NOT COMPLETED
12 0
64 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
12
64

Baseline Characteristics

Age for patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard TranS-C (Immediate)
n=8 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=70 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=8 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=57 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 - Providers
n=6 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 - Providers
n=47 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=196 Participants
Total of all reporting groups
Age, Continuous
43.75 Years
STANDARD_DEVIATION 13.18 • n=8 Participants • Age for patients
43.26 Years
STANDARD_DEVIATION 15.35 • n=70 Participants • Age for patients
46.25 Years
STANDARD_DEVIATION 8.21 • n=8 Participants • Age for patients
43.43 Years
STANDARD_DEVIATION 14.43 • n=57 Participants • Age for patients
39.50 Years
STANDARD_DEVIATION 12.40 • n=6 Participants • Data not collected for this Baseline Measure from patients.
40.21 Years
STANDARD_DEVIATION 10.19 • n=47 Participants • Data not collected for this Baseline Measure from patients.
40.13 Years
STANDARD_DEVIATION 10.33 • n=53 Participants • Data not collected for this Baseline Measure from patients.
Sex/Gender, Customized
Female
5 Participants
n=8 Participants
42 Participants
n=70 Participants
4 Participants
n=8 Participants
39 Participants
n=57 Participants
5 Participants
n=6 Participants
33 Participants
n=47 Participants
128 Participants
n=196 Participants
Sex/Gender, Customized
Male
3 Participants
n=8 Participants
28 Participants
n=70 Participants
4 Participants
n=8 Participants
18 Participants
n=57 Participants
0 Participants
n=6 Participants
2 Participants
n=47 Participants
55 Participants
n=196 Participants
Sex/Gender, Customized
Missing/declined to answer
0 Participants
n=8 Participants
0 Participants
n=70 Participants
0 Participants
n=8 Participants
0 Participants
n=57 Participants
1 Participants
n=6 Participants
12 Participants
n=47 Participants
13 Participants
n=196 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=8 Participants
18 Participants
n=70 Participants
1 Participants
n=8 Participants
8 Participants
n=57 Participants
1 Participants
n=6 Participants
8 Participants
n=47 Participants
40 Participants
n=196 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=8 Participants
52 Participants
n=70 Participants
6 Participants
n=8 Participants
49 Participants
n=57 Participants
4 Participants
n=6 Participants
25 Participants
n=47 Participants
140 Participants
n=196 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
0 Participants
n=70 Participants
1 Participants
n=8 Participants
0 Participants
n=57 Participants
1 Participants
n=6 Participants
14 Participants
n=47 Participants
16 Participants
n=196 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=8 Participants
5 Participants
n=70 Participants
0 Participants
n=8 Participants
2 Participants
n=57 Participants
0 Participants
n=6 Participants
0 Participants
n=47 Participants
7 Participants
n=196 Participants
Race (NIH/OMB)
Asian
0 Participants
n=8 Participants
0 Participants
n=70 Participants
0 Participants
n=8 Participants
3 Participants
n=57 Participants
1 Participants
n=6 Participants
7 Participants
n=47 Participants
11 Participants
n=196 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=8 Participants
6 Participants
n=70 Participants
2 Participants
n=8 Participants
7 Participants
n=57 Participants
0 Participants
n=6 Participants
0 Participants
n=47 Participants
15 Participants
n=196 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=8 Participants
12 Participants
n=70 Participants
2 Participants
n=8 Participants
12 Participants
n=57 Participants
2 Participants
n=6 Participants
1 Participants
n=47 Participants
32 Participants
n=196 Participants
Race (NIH/OMB)
White
2 Participants
n=8 Participants
32 Participants
n=70 Participants
2 Participants
n=8 Participants
22 Participants
n=57 Participants
1 Participants
n=6 Participants
24 Participants
n=47 Participants
83 Participants
n=196 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=8 Participants
12 Participants
n=70 Participants
1 Participants
n=8 Participants
8 Participants
n=57 Participants
1 Participants
n=6 Participants
1 Participants
n=47 Participants
23 Participants
n=196 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=8 Participants
3 Participants
n=70 Participants
1 Participants
n=8 Participants
3 Participants
n=57 Participants
1 Participants
n=6 Participants
14 Participants
n=47 Participants
25 Participants
n=196 Participants
Region of Enrollment
United States
8 participants
n=8 Participants
70 participants
n=70 Participants
8 participants
n=8 Participants
57 participants
n=57 Participants
6 participants
n=6 Participants
47 participants
n=47 Participants
196 participants
n=196 Participants
Education
High school graduate or below
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
6 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
5 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
14 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Education
Some or completed college or vocational school
4 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
45 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
4 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
34 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
87 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Education
Some or completed graduate school
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
17 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
17 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
38 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Education
Other/ category not listed
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Education
Missing/ declined to answer
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Employment
Full-time
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
13 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
11 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
28 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Employment
Part-time
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
10 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
9 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
22 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Employment
Not employed
5 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
45 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
34 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
86 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Employment
Other/ category not listed
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Civil Status
Partnered
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
16 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
9 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
28 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Civil Status
Unpartnered
7 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
54 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
5 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
47 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
113 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Civil Status
Other/ category not listed
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Civil Status
Missing/ declined to answer
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement
Alone
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
14 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
11 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
27 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement
With family
5 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
38 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
31 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
81 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement
With friend or roommate or With friend or roommate or pet
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
13 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
22 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement
Supportive housing
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
4 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
6 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
10 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement
Other/ category not listed
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Living Arrangement
Missing/ declined to answer
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Unemployment
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Medicare
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
8 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
12 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Medicaid
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
26 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
20 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
50 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Social Security
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
6 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
16 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Food Stamps
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
14 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
13 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
30 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Supplemental Security Income/ Social Security Disability Insurance
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
15 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
10 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
27 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Supplemental Nutrition Assistance Program
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
8 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
6 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
15 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Other/category not listed
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
10 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
21 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Government Assistance
Missing/declined to answer
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
21 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
4 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
17 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
43 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
<$10,000
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
13 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
21 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
$10,000-$20,000
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
14 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
9 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
27 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
$20,000-$30,000
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
6 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
4 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
15 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
$30,000-$40,000
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
5 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
$40,000-$50,000
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
4 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
>= $50,000
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
14 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
17 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
32 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
I don't know my income
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
18 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
11 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
32 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Annual Household Income
Missing/ declined to answer
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Neurodevelopmental disorders
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
10 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
11 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
22 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Psychosis
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
20 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
13 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
36 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Bipolar Disorder
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
15 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
8 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
25 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Major Depressive Disorder
4 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
31 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
28 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
66 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Anxiety disorders
3 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
30 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
5 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
34 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
72 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Obsessive- compulsive and related disorders
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
5 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Trauma and stressor-related disorders
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
14 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
17 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
33 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Dissociative disorders
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Personality disorders
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Feeding and eating disorders
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Substance-related and addictive disorders
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
5 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Other/category not listed
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
1 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
2 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
3 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Self-reported Diagnosis
Missing/declined to answer
1 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=70 Participants • Data not collected for this Baseline Measure from providers.
0 Participants
n=8 Participants • Data not collected for this Baseline Measure from providers.
7 Participants
n=57 Participants • Data not collected for this Baseline Measure from providers.
15 Participants
n=143 Participants • Data not collected for this Baseline Measure from providers.
Degree Type
Marriage and Family Therapy
0 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
4 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
4 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Degree Type
Psychology
1 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
4 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
5 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Degree Type
Social Work
4 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
15 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
19 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Degree Type
Nursing
0 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
8 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
8 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Degree Type
Medical
0 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
1 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
1 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Degree Type
Other/category not listed
0 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
4 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
4 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Degree Type
Missing/declined to answer
1 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
12 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
13 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Client Centered
5 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
29 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
34 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Family Systems
0 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
8 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
8 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Cognitive Behavioral Therapy
2 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
20 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
22 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Psychodynamic
1 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
11 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
12 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Humanistic
1 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
7 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
8 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Integrative/Holistic
0 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
2 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
2 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Therapeutic Approach
Missing/declined to answer
1 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
13 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
14 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Licensure
Licensed
3 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
24 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
27 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Licensure
Not Licensed
2 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
11 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
13 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Licensure
Missing/ declined to answer
1 Participants
n=6 Participants • Data not collected for this Baseline Measure from patients.
12 Participants
n=47 Participants • Data not collected for this Baseline Measure from patients.
13 Participants
n=53 Participants • Data not collected for this Baseline Measure from patients.
Caseload
33.00 Number of patients
STANDARD_DEVIATION 37.24 • n=6 Participants • Data not collected for this Baseline Measure from patients.
33.29 Number of patients
STANDARD_DEVIATION 40.18 • n=47 Participants • Data not collected for this Baseline Measure from patients.
33.26 Number of patients
STANDARD_DEVIATION 39.17 • n=53 Participants • Data not collected for this Baseline Measure from patients.
Employment Duration
1.20 Years
STANDARD_DEVIATION 1.10 • n=6 Participants • Data not collected for this Baseline Measure from patients.
5.41 Years
STANDARD_DEVIATION 6.23 • n=47 Participants • Data not collected for this Baseline Measure from patients.
4.86 Years
STANDARD_DEVIATION 5.98 • n=53 Participants • Data not collected for this Baseline Measure from patients.
Years Since Degree Earned
6.40 Years
STANDARD_DEVIATION 6.43 • n=6 Participants • Data not collected for this Baseline Measure from patients.
9.63 Years
STANDARD_DEVIATION 9.69 • n=47 Participants • Data not collected for this Baseline Measure from patients.
9.26 Years
STANDARD_DEVIATION 9.39 • n=53 Participants • Data not collected for this Baseline Measure from patients.

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
Standard TranS-C (Immediate)
n=8 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=70 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=8 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=57 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=78 Participants
Standard and Adapted TranS-C combined for participants randomized to the immediate condition.
UC-DT
n=65 Participants
Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Standard TranS-C
n=16 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 or after usual-care delayed treatment.
Adapted TranS-C
n=127 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 or after usual-care delayed treatment.
TranS-C
n=143 Participants
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
Baseline
66.67 T-score
Standard Deviation 6.44
62.21 T-score
Standard Deviation 7.73
60.54 T-score
Standard Deviation 5.63
62.24 T-score
Standard Deviation 7.34
62.71 T-score
Standard Deviation 7.69
62.05 T-score
Standard Deviation 7.14
63.81 T-score
Standard Deviation 6.66
62.23 T-score
Standard Deviation 7.52
62.40 T-score
Standard Deviation 7.42
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
Mid-treatment
49.55 T-score
Standard Deviation 2.33
53.81 T-score
Standard Deviation 9.58
53.60 T-score
Standard Deviation 9.39
50.08 T-score
Standard Deviation 2.65
55.10 T-score
Standard Deviation 9.27
54.80 T-score
Standard Deviation 9.08
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
Post-treatment
51.05 T-score
Standard Deviation 15.23
55.06 T-score
Standard Deviation 10.76
61.48 T-score
Standard Deviation 10.37
61.04 T-score
Standard Deviation 8.52
54.74 T-score
Standard Deviation 11.04
61.08 T-score
Standard Deviation 8.59
54.21 T-score
Standard Deviation 12.22
55.21 T-score
Standard Deviation 11.18
55.12 T-score
Standard Deviation 11.19
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
6-month follow-up
52.35 T-score
Standard Deviation 5.83
52.48 T-score
Standard Deviation 10.34
52.47 T-score
Standard Deviation 10.07
54.86 T-score
Standard Deviation 6.74
53.54 T-score
Standard Deviation 10.05
53.63 T-score
Standard Deviation 9.84

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).

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

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=6 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=47 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=53 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)
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.
Standard TranS-C
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 or after usual-care delayed treatment.
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 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 or after usual-care delayed treatment.
TranS-C
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Provider-level Outcome: Acceptability Intervention Measure
Baseline
4.90 score on a scale
Standard Deviation 0.22
4.74 score on a scale
Standard Deviation 0.41
4.76 score on a scale
Standard Deviation 0.39
Provider-level Outcome: Acceptability Intervention Measure
Mid-treatment
5.00 score on a scale
Standard Deviation 0.00
4.64 score on a scale
Standard Deviation 0.44
4.65 score on a scale
Standard Deviation 0.44
Provider-level Outcome: Acceptability Intervention Measure
Post-treatment
5.00 score on a scale
Standard Deviation 0.00
4.54 score on a scale
Standard Deviation 0.58
4.56 score on a scale
Standard Deviation 0.57

SECONDARY outcome

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

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

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=8 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=70 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=8 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=57 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=78 Participants
Standard and Adapted TranS-C combined for participants randomized to the immediate condition.
UC-DT
n=65 Participants
Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Standard TranS-C
n=16 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 or after usual-care delayed treatment.
Adapted TranS-C
n=127 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 or after usual-care delayed treatment.
TranS-C
n=143 Participants
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Baseline
63.12 T-score
Standard Deviation 10.63
60.30 T-score
Standard Deviation 8.57
59.24 T-score
Standard Deviation 10.79
60.09 T-score
Standard Deviation 8.58
60.59 T-score
Standard Deviation 8.76
59.98 T-score
Standard Deviation 8.79
61.18 T-score
Standard Deviation 10.54
60.20 T-score
Standard Deviation 8.54
60.31 T-score
Standard Deviation 8.75
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Mid-treatment
60.20 T-score
Standard Deviation 5.80
55.67 T-score
Standard Deviation 10.66
55.89 T-score
Standard Deviation 10.47
55.83 T-score
Standard Deviation 8.82
56.76 T-score
Standard Deviation 10.45
56.70 T-score
Standard Deviation 10.30
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Post-treatment
48.65 T-score
Standard Deviation 12.87
52.80 T-score
Standard Deviation 11.90
59.66 T-score
Standard Deviation 6.61
57.71 T-score
Standard Deviation 8.58
52.46 T-score
Standard Deviation 11.90
57.88 T-score
Standard Deviation 8.39
52.74 T-score
Standard Deviation 10.56
53.54 T-score
Standard Deviation 11.14
53.48 T-score
Standard Deviation 11.03
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
6-month follow-up
50.75 T-score
Standard Deviation 9.05
53.82 T-score
Standard Deviation 11.29
53.62 T-score
Standard Deviation 11.12
54.27 T-score
Standard Deviation 9.82
54.71 T-score
Standard Deviation 10.90
54.68 T-score
Standard Deviation 10.79

SECONDARY outcome

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

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

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=8 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=70 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=8 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=57 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=78 Participants
Standard and Adapted TranS-C combined for participants randomized to the immediate condition.
UC-DT
n=65 Participants
Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Standard TranS-C
n=16 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 or after usual-care delayed treatment.
Adapted TranS-C
n=127 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 or after usual-care delayed treatment.
TranS-C
n=143 Participants
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Patient-level Outcome: Composite Sleep Health Score
Baseline
3.00 score on a scale
Standard Deviation 1.10
2.25 score on a scale
Standard Deviation 1.29
2.29 score on a scale
Standard Deviation 1.50
2.45 score on a scale
Standard Deviation 1.47
2.31 score on a scale
Standard Deviation 1.28
2.43 score on a scale
Standard Deviation 1.46
2.62 score on a scale
Standard Deviation 1.33
2.33 score on a scale
Standard Deviation 1.37
2.36 score on a scale
Standard Deviation 1.36
Patient-level Outcome: Composite Sleep Health Score
Mid-treatment
3.50 score on a scale
Standard Deviation 2.12
3.28 score on a scale
Standard Deviation 1.54
3.29 score on a scale
Standard Deviation 1.54
3.50 score on a scale
Standard Deviation 1.73
3.05 score on a scale
Standard Deviation 1.54
3.08 score on a scale
Standard Deviation 1.55
Patient-level Outcome: Composite Sleep Health Score
Post-treatment
3.33 score on a scale
Standard Deviation 2.52
3.07 score on a scale
Standard Deviation 1.59
3.00 score on a scale
Standard Deviation 1.41
2.66 score on a scale
Standard Deviation 1.45
3.09 score on a scale
Standard Deviation 1.63
2.69 score on a scale
Standard Deviation 1.44
2.50 score on a scale
Standard Deviation 2.07
3.07 score on a scale
Standard Deviation 1.52
3.03 score on a scale
Standard Deviation 1.56
Patient-level Outcome: Composite Sleep Health Score
6-month follow-up
4.00 score on a scale
Standard Deviation 1.41
2.94 score on a scale
Standard Deviation 1.62
3.02 score on a scale
Standard Deviation 1.62
3.57 score on a scale
Standard Deviation 1.62
2.90 score on a scale
Standard Deviation 1.52
2.95 score on a scale
Standard Deviation 1.53

SECONDARY outcome

Timeframe: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.

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

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=8 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=70 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=8 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=57 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=78 Participants
Standard and Adapted TranS-C combined for participants randomized to the immediate condition.
UC-DT
n=65 Participants
Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Standard TranS-C
n=16 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 or after usual-care delayed treatment.
Adapted TranS-C
n=127 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 or after usual-care delayed treatment.
TranS-C
n=143 Participants
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Patient-level Outcome: Sheehan Disability Scale
Baseline
15.25 score on a scale
Standard Deviation 6.63
12.49 score on a scale
Standard Deviation 7.72
11.75 score on a scale
Standard Deviation 10.07
11.88 score on a scale
Standard Deviation 7.04
12.77 score on a scale
Standard Deviation 7.62
11.86 score on a scale
Standard Deviation 7.38
13.50 score on a scale
Standard Deviation 8.43
12.21 score on a scale
Standard Deviation 7.40
12.36 score on a scale
Standard Deviation 7.50
Patient-level Outcome: Sheehan Disability Scale
Post-treatment
6.50 score on a scale
Standard Deviation 6.35
7.98 score on a scale
Standard Deviation 7.06
10.80 score on a scale
Standard Deviation 7.66
11.10 score on a scale
Standard Deviation 7.51
7.86 score on a scale
Standard Deviation 6.95
11.07 score on a scale
Standard Deviation 7.46
8.86 score on a scale
Standard Deviation 7.73
8.36 score on a scale
Standard Deviation 6.47
8.40 score on a scale
Standard Deviation 6.54
Patient-level Outcome: Sheehan Disability Scale
6-month follow-up
9.75 score on a scale
Standard Deviation 8.26
8.51 score on a scale
Standard Deviation 7.06
8.59 score on a scale
Standard Deviation 7.07
9.71 score on a scale
Standard Deviation 8.46
8.70 score on a scale
Standard Deviation 7.05
8.77 score on a scale
Standard Deviation 7.11

SECONDARY outcome

Timeframe: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.

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

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=8 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=70 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=8 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=57 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=78 Participants
Standard and Adapted TranS-C combined for participants randomized to the immediate condition.
UC-DT
n=65 Participants
Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition.
Standard TranS-C
n=16 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 or after usual-care delayed treatment.
Adapted TranS-C
n=127 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 or after usual-care delayed treatment.
TranS-C
n=143 Participants
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
Baseline
25.38 score on a scale
Standard Deviation 8.93
23.48 score on a scale
Standard Deviation 8.70
18.75 score on a scale
Standard Deviation 5.18
23.25 score on a scale
Standard Deviation 9.48
22.69 score on a scale
Standard Deviation 9.15
23.68 score on a scale
Standard Deviation 8.69
22.06 score on a scale
Standard Deviation 7.84
23.37 score on a scale
Standard Deviation 9.03
23.23 score on a scale
Standard Deviation 8.89
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
Post-treatment
14.00 score on a scale
Standard Deviation 10.68
17.91 score on a scale
Standard Deviation 9.61
20.60 score on a scale
Standard Deviation 5.32
20.67 score on a scale
Standard Deviation 8.74
17.59 score on a scale
Standard Deviation 9.64
20.67 score on a scale
Standard Deviation 8.46
16.14 score on a scale
Standard Deviation 8.07
18.00 score on a scale
Standard Deviation 9.34
17.84 score on a scale
Standard Deviation 9.20
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
6-month follow-up
14.25 score on a scale
Standard Deviation 8.30
18.47 score on a scale
Standard Deviation 10.16
18.19 score on a scale
Standard Deviation 10.04
17.29 score on a scale
Standard Deviation 7.20
18.24 score on a scale
Standard Deviation 9.51
18.18 score on a scale
Standard Deviation 9.34

SECONDARY 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).

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

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=6 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=47 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=53 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)
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.
Standard TranS-C
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 or after usual-care delayed treatment.
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 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 or after usual-care delayed treatment.
TranS-C
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Provider-level Outcome: Intervention Appropriateness Measure
Baseline
5.00 score on a scale
Standard Deviation 0.00
4.79 score on a scale
Standard Deviation 0.35
4.82 score on a scale
Standard Deviation 0.33
Provider-level Outcome: Intervention Appropriateness Measure
Mid-treatment
4.83 score on a scale
Standard Deviation 0.29
4.56 score on a scale
Standard Deviation 0.52
4.58 score on a scale
Standard Deviation 0.51
Provider-level Outcome: Intervention Appropriateness Measure
Post-treatment
4.75 score on a scale
Standard Deviation 0.50
4.39 score on a scale
Standard Deviation 0.67
4.41 score on a scale
Standard Deviation 0.67

SECONDARY 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).

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

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=6 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=47 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=53 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)
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.
Standard TranS-C
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 or after usual-care delayed treatment.
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 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 or after usual-care delayed treatment.
TranS-C
Collapsed across TranS-C condition (Standard, Adapted) and treatment condition (Immediate, UC-DT)
Provider-level Outcome: Feasibility of Intervention Measure
Mid-treatment
4.83 score on a scale
Standard Deviation 0.29
4.60 score on a scale
Standard Deviation 0.54
4.61 score on a scale
Standard Deviation 0.53
Provider-level Outcome: Feasibility of Intervention Measure
Post-treatment
4.44 score on a scale
Standard Deviation 0.72
4.42 score on a scale
Standard Deviation 0.65
4.43 score on a scale
Standard Deviation 0.65
Provider-level Outcome: Feasibility of Intervention Measure
Baseline
4.95 score on a scale
Standard Deviation 0.11
4.59 score on a scale
Standard Deviation 0.57
4.64 score on a scale
Standard Deviation 0.54

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Assesses past 30-day frequency of substance use using a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Assesses past 30-day suicidal ideation using a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.

Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.

Measures the elements of TranS-C that are most used.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at 6-month follow-up after treatment ends.

Measures the elements of TranS-C that are most used.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at baseline.

Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at each session between patient and provider.

Assesses which treatment modules were delivered by the providers using a self-report checklist.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.

Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once during the 1 year sustainment phase.

Assesses if providers continue to use TranS-C in a self-report questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once at each session between patient and provider.

Collect session date and duration (length of session).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through the first 2.5 years of the study, an average of 4 per month

Provider evaluation of the training; provider knowledge of content covered in the training; provider willingness and confidence in delivering TranS-C.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through the first 2.5 years of the study, an average of 4 per month

Extent of gold standard training elements present in each training session, with respect to content and technique.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment

Number of sessions delivered to each enrolled patient by each provider.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 months

Weekly record of facilitator activities, amount of time per activity, county, year, type of communication, implementation strategies, target(s), intended outcome(s).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 months

Weekly record of community meeting details as applicable, including: county, generation, level of contact (i.e., leadership, providers), type/modality of contact, length of meeting, number of attendees, recording, general description, standardized description, main presenter and role of UC Berkeley staff.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment

Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client

Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.

Outcome measures

Outcome data not reported

Adverse Events

Standard TranS-C (Immediate)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Adapted TranS-C (Immediate)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard TranS-C (UC-DT)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Adapted TranS-C (UC-DT)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard TranS-C - Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Adapted TranS-C - Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Allison Harvey, Professor of Clinical Psychology

University of California, Berkeley

Phone: 5104736490

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place