Better Sleep Study
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Children's Hospital Los Angeles
- Study ID
- NCT06139861
- Status
- Recruiting
Conditions
- Delayed Sleep Phase
- Depression in Adolescence
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- TranS-C — BEHAVIORALTransdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.
- Psychoeducation — BEHAVIORALThe overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.
Study Details
The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.
Key Dates
- Start date
- Mar 15, 2024
- Status verified
- May 2026
- Primary completion
- Aug 1, 2028
- Completion
- Aug 1, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TranS-C
- Active Comparator: Psychoeducation
Primary Outcome Measure
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME ) [ Time Frame: baseline to end of treatment (0 and 2 months) ]
Central Contacts
- Lauren Asarnow, PhD323-361-2471
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Lauren Asarnow, PhD (PRINCIPAL_INVESTIGATOR) |
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