N/A
N=121
A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Mental Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02469233 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Impairment (Sheehan Disability Scale) — 14.30; 12.03; 11.76; 6.57 score on a scale — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Berkeley
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impairment (Sheehan Disability Scale) |
14.30; 12.03; 11.76; 6.57; 10.51; 7.00 | 0.025 sig |
| PRIMARY Disorder-Focused Composite Score (DSM-5) |
25.57; 25.05; 23.53; 17.00; 23.07; 18.67 | 0.001 sig |
| PRIMARY Sleep and Circadian Function: PROMIS-Sleep Disturbance |
29.02; 28.26; 27.33; 20.88; 26.40; 20.87 | <0.0001 sig |
| PRIMARY Sleep and Circadian Function: PROMIS-Sleep-Related Impairment |
51.02; 47.93; 47.22; 35.16; 44.30; 35.65 | <0.0001 sig |
| SECONDARY Depression (QIDS) |
12.50; 12.03; 10.55; 8.88; 10.67; 8.46 | 0.32 |
| SECONDARY Substance Use (ASSIST ) |
33.68; 39.70; 14.62; 15.35; 32.58; 34.60 | 0.72 |
| SECONDARY Psychotic Symptoms (PSYRATS ) |
36.60; 39.60; 41.73; 36.00; 42.58; 25.80 | 0.73 |
| SECONDARY Means and Variability of Sleep Efficiency (Daily Sleep Diary) |
77.61; 77.39; 12.52; 11.92; 78.93; 84.31 | 0.03 sig |
| SECONDARY Actigraphy Measured Sleep (TST) |
421.35; 453.65; 132.08; 132.34; 411.82; 427.23 | 0.59 |
| SECONDARY Daytime Activity (Actigraphy) |
1309.74; 1280.09; 379.69; 394.04; 1361.19; 1257.82 | 0.34 |
| SECONDARY Impairment (World Health Organization Disability Assessment Schedule 2.0) |
81.53; 76.48; 81.48; 68.93; 73.45; 66.63 | 0.09 |
| SECONDARY Overall Health ('Healthy Days' Core Module) |
3.57; 3.44; 3.40; 3.37; 3.40; 3.37 | 0.46 |
| SECONDARY Composite Sleep Health Score |
2.28; 2.54; 2.34; 3.45; 2.53; 3.38 | 0.002 sig |
| SECONDARY Means and Variability of Total Sleep Time (Daily Sleep Diary) |
452.42; 431.06; 109.59; 103.96; 459.09; 450.71 | 0.23 |
| SECONDARY Means and Variability of Total Wake Time (Daily Sleep Diary) |
131.89; 124.84; 77.85; 74.04; 131.29; 84.37 | 0.04 sig |
| SECONDARY Means and Variability of Bedtime (Daily Sleep Diary) |
22.20; 22.17; 1.39; 1.28; 22.39; 22.00 | 0.10 |
| SECONDARY Means and Variability of Wake Time (Daily Sleep Diary) |
7.90; 7.31; 1.42; 1.34; 8.26; 7.31 | 0.39 |
| SECONDARY Actigraphy Measured Sleep (TWT) |
91.06; 94.95; 55.65; 54.46; 91.39; 90.80 | 0.66 |
Summary
Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to determine if an intervention to improve sleep can improve functioning and reduce symptoms and impairment. The investigators will conduct this study in community mental health centers to ensure that the results contribute to closing the worrisome gap between research and practice and to ensure that the findings are generalizable to the real world.
Eligibility Criteria
Inclusion Criteria
- Age 18+ years
- English language fluency
- Presence of at least one DSM-V mental disorder for 12 months
- One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview:
- ≥30 mins to get to sleep , 3 or more nights per week
- Waking in the middle of the night for ≥30 minutes, 3 or more nights per week
- Obtaining less than 6 hours of sleep per night, 3 or more nights per week
- Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week
- More than 2.78 hours of variability in sleep-wake schedule across one week
- Bedtime later than 2 am, 3 or more nights per week
- Guaranteed bed to sleep in for the duration of the treatment phase
- Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager
Exclusion Criteria
- Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible.
- Current serious suicide risk (assessed by our staff, a case manager or psychiatrist) or homicide risk (assessed by our staff, a case manager or psychiatrist)
- Night shift work >2 nights per week in the past 3 months
- Pregnancy or breast-feeding
- Not able/willing to participate in and/or complete the pre-treatment assessments
Data sourced from ClinicalTrials.gov (NCT02469233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.