Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer
CompletedNAResults postedLast updated 23 October 2025
What this trial tests
NA trial testing Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in Sleep Disorder in 196 participants. Completed in 8 May 2024.
Timeline
14 December 2020
Primary endpoint 8 May 2024
8 May 2024
Quick facts
Lead sponsor
University of California, Berkeley
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
single
Primary purpose
health services research
Enrollment
196
Start date
14 December 2020
Primary completion
8 May 2024
Estimated completion
8 May 2024
Sites
9 locations across United States
Drugs / interventions tested
Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
18 and older, any sex, with Sleep Disorder or Circadian Dysregulation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep DisturbancePrimary· Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate wors
Baseline
Group
Value
95% CI
Standard TranS-C (Immediate)
66.67
± 6.44
Adapted TranS-C (Immediate)
62.21
± 7.73
Standard TranS-C (UC-DT)
60.54
± 5.63
Adapted TranS-C (UC-DT)
62.24
± 7.34
Immediate TranS-C
62.71
± 7.69
UC-DT
62.05
± 7.14
Standard TranS-C
63.81
± 6.66
Adapted TranS-C
62.23
± 7.52
TranS-C
62.40
± 7.42
Mid-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
49.55
± 2.33
Adapted TranS-C (Immediate)
53.81
± 9.58
Immediate TranS-C
53.60
± 9.39
Standard TranS-C
50.08
± 2.65
Adapted TranS-C
55.10
± 9.27
TranS-C
54.80
± 9.08
Post-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
51.05
± 15.23
Adapted TranS-C (Immediate)
55.06
± 10.76
Standard TranS-C (UC-DT)
61.48
± 10.37
Adapted TranS-C (UC-DT)
61.04
± 8.52
Immediate TranS-C
54.74
± 11.04
UC-DT
61.08
± 8.59
Standard TranS-C
54.21
± 12.22
Adapted TranS-C
55.21
± 11.18
TranS-C
55.12
± 11.19
6-month follow-up
Group
Value
95% CI
Standard TranS-C (Immediate)
52.35
± 5.83
Adapted TranS-C (Immediate)
52.48
± 10.34
Immediate TranS-C
52.47
± 10.07
Standard TranS-C
54.86
± 6.74
Adapted TranS-C
53.54
± 10.05
TranS-C
53.63
± 9.84
Provider-level Outcome: Acceptability Intervention MeasurePrimary· Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability.
Baseline
Group
Value
95% CI
Standard TranS-C - Providers
4.90
± 0.22
Adapted TranS-C - Providers
4.74
± 0.41
TranS-C - Providers
4.76
± 0.39
Mid-treatment
Group
Value
95% CI
Standard TranS-C - Providers
5.00
± 0.00
Adapted TranS-C - Providers
4.64
± 0.44
TranS-C - Providers
4.65
± 0.44
Post-treatment
Group
Value
95% CI
Standard TranS-C - Providers
5.00
± 0.00
Adapted TranS-C - Providers
4.54
± 0.58
TranS-C - Providers
4.56
± 0.57
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related ImpairmentSecondary· Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep 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
Baseline
Group
Value
95% CI
Standard TranS-C (Immediate)
63.12
± 10.63
Adapted TranS-C (Immediate)
60.30
± 8.57
Standard TranS-C (UC-DT)
59.24
± 10.79
Adapted TranS-C (UC-DT)
60.09
± 8.58
Immediate TranS-C
60.59
± 8.76
UC-DT
59.98
± 8.79
Standard TranS-C
61.18
± 10.54
Adapted TranS-C
60.20
± 8.54
TranS-C
60.31
± 8.75
Mid-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
60.20
± 5.80
Adapted TranS-C (Immediate)
55.67
± 10.66
Immediate TranS-C
55.89
± 10.47
Standard TranS-C
55.83
± 8.82
Adapted TranS-C
56.76
± 10.45
TranS-C
56.70
± 10.30
Post-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
48.65
± 12.87
Adapted TranS-C (Immediate)
52.80
± 11.90
Standard TranS-C (UC-DT)
59.66
± 6.61
Adapted TranS-C (UC-DT)
57.71
± 8.58
Immediate TranS-C
52.46
± 11.90
UC-DT
57.88
± 8.39
Standard TranS-C
52.74
± 10.56
Adapted TranS-C
53.54
± 11.14
TranS-C
53.48
± 11.03
6-month follow-up
Group
Value
95% CI
Standard TranS-C (Immediate)
50.75
± 9.05
Adapted TranS-C (Immediate)
53.82
± 11.29
Immediate TranS-C
53.62
± 11.12
Standard TranS-C
54.27
± 9.82
Adapted TranS-C
54.71
± 10.90
TranS-C
54.68
± 10.79
Patient-level Outcome: Composite Sleep Health ScoreSecondary· 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.
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%)
Baseline
Group
Value
95% CI
Standard TranS-C (Immediate)
3.00
± 1.10
Adapted TranS-C (Immediate)
2.25
± 1.29
Standard TranS-C (UC-DT)
2.29
± 1.50
Adapted TranS-C (UC-DT)
2.45
± 1.47
Immediate TranS-C
2.31
± 1.28
UC-DT
2.43
± 1.46
Standard TranS-C
2.62
± 1.33
Adapted TranS-C
2.33
± 1.37
TranS-C
2.36
± 1.36
Mid-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
3.50
± 2.12
Adapted TranS-C (Immediate)
3.28
± 1.54
Immediate TranS-C
3.29
± 1.54
Standard TranS-C
3.50
± 1.73
Adapted TranS-C
3.05
± 1.54
TranS-C
3.08
± 1.55
Post-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
3.33
± 2.52
Adapted TranS-C (Immediate)
3.07
± 1.59
Standard TranS-C (UC-DT)
3.00
± 1.41
Adapted TranS-C (UC-DT)
2.66
± 1.45
Immediate TranS-C
3.09
± 1.63
UC-DT
2.69
± 1.44
Standard TranS-C
2.50
± 2.07
Adapted TranS-C
3.07
± 1.52
TranS-C
3.03
± 1.56
6-month follow-up
Group
Value
95% CI
Standard TranS-C (Immediate)
4.00
± 1.41
Adapted TranS-C (Immediate)
2.94
± 1.62
Immediate TranS-C
3.02
± 1.62
Standard TranS-C
3.57
± 1.62
Adapted TranS-C
2.90
± 1.52
TranS-C
2.95
± 1.53
Patient-level Outcome: Sheehan Disability ScaleSecondary· Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
The 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.
Baseline
Group
Value
95% CI
Standard TranS-C (Immediate)
15.25
± 6.63
Adapted TranS-C (Immediate)
12.49
± 7.72
Standard TranS-C (UC-DT)
11.75
± 10.07
Adapted TranS-C (UC-DT)
11.88
± 7.04
Immediate TranS-C
12.77
± 7.62
UC-DT
11.86
± 7.38
Standard TranS-C
13.50
± 8.43
Adapted TranS-C
12.21
± 7.40
TranS-C
12.36
± 7.50
Post-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
6.50
± 6.35
Adapted TranS-C (Immediate)
7.98
± 7.06
Standard TranS-C (UC-DT)
10.80
± 7.66
Adapted TranS-C (UC-DT)
11.10
± 7.51
Immediate TranS-C
7.86
± 6.95
UC-DT
11.07
± 7.46
Standard TranS-C
8.86
± 7.73
Adapted TranS-C
8.36
± 6.47
TranS-C
8.40
± 6.54
6-month follow-up
Group
Value
95% CI
Standard TranS-C (Immediate)
9.75
± 8.26
Adapted TranS-C (Immediate)
8.51
± 7.06
Immediate TranS-C
8.59
± 7.07
Standard TranS-C
9.71
± 8.46
Adapted TranS-C
8.70
± 7.05
TranS-C
8.77
± 7.11
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom MeasureSecondary· Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
The 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.
Baseline
Group
Value
95% CI
Standard TranS-C (Immediate)
25.38
± 8.93
Adapted TranS-C (Immediate)
23.48
± 8.70
Standard TranS-C (UC-DT)
18.75
± 5.18
Adapted TranS-C (UC-DT)
23.25
± 9.48
Immediate TranS-C
22.69
± 9.15
UC-DT
23.68
± 8.69
Standard TranS-C
22.06
± 7.84
Adapted TranS-C
23.37
± 9.03
TranS-C
23.23
± 8.89
Post-treatment
Group
Value
95% CI
Standard TranS-C (Immediate)
14.00
± 10.68
Adapted TranS-C (Immediate)
17.91
± 9.61
Standard TranS-C (UC-DT)
20.60
± 5.32
Adapted TranS-C (UC-DT)
20.67
± 8.74
Immediate TranS-C
17.59
± 9.64
UC-DT
20.67
± 8.46
Standard TranS-C
16.14
± 8.07
Adapted TranS-C
18.00
± 9.34
TranS-C
17.84
± 9.20
6-month follow-up
Group
Value
95% CI
Standard TranS-C (Immediate)
14.25
± 8.30
Adapted TranS-C (Immediate)
18.47
± 10.16
Immediate TranS-C
18.19
± 10.04
Standard TranS-C
17.29
± 7.20
Adapted TranS-C
18.24
± 9.51
TranS-C
18.18
± 9.34
Provider-level Outcome: Intervention Appropriateness MeasureSecondary· Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the 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.
Baseline
Group
Value
95% CI
Standard TranS-C - Providers
5.00
± 0.00
Adapted TranS-C - Providers
4.79
± 0.35
TranS-C Providers
4.82
± 0.33
Mid-treatment
Group
Value
95% CI
Standard TranS-C - Providers
4.83
± 0.29
Adapted TranS-C - Providers
4.56
± 0.52
TranS-C Providers
4.58
± 0.51
Post-treatment
Group
Value
95% CI
Standard TranS-C - Providers
4.75
± 0.50
Adapted TranS-C - Providers
4.39
± 0.67
TranS-C Providers
4.41
± 0.67
Provider-level Outcome: Feasibility of Intervention MeasureSecondary· Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the 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.
Baseline
Group
Value
95% CI
Standard TranS-C - Providers
4.95
± 0.11
Adapted TranS-C - Providers
4.59
± 0.57
TranS-C - Providers
4.64
± 0.54
Mid-treatment
Group
Value
95% CI
Standard TranS-C - Providers
4.83
± 0.29
Adapted TranS-C - Providers
4.60
± 0.54
TranS-C - Providers
4.61
± 0.53
Post-treatment
Group
Value
95% CI
Standard TranS-C - Providers
4.44
± 0.72
Adapted TranS-C - Providers
4.42
± 0.65
TranS-C - Providers
4.43
± 0.65
Sponsor's own description
The train-the-trainer (TTT) approach is a promising method of sustaining training efforts in community mental health centers (CMHCs). This study will test the implementation and effectiveness outcomes of a sleep treatment delivered by CMHC providers who are trained and supervised within CMHCs via TTT. The investigators will test two versions of the sleep treatment, a "Standard" version and an "Adapted" version that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Berkeley
Last refreshed: 23 October 2025
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