RecruitingNot Applicable

Better Sleep Study

United States200 participantsStarted 2024-03-15

Plain-language summary

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.

Who can participate

Age range12 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Exclusion Criteria: * mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence * severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer) * current use of medications or herbs with known effects on sleep * plan to undergo or have had medication change in the last 8 weeks

What they're measuring

Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )

Timeframe: baseline to end of treatment (0 and 2 months)

Change in Children's Depression Rating Scale (CDRS-R)

Timeframe: baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14

Trial details

NCT IDNCT06139861

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-01

Contact for this trial

Lauren Asarnow, PhD

323-361-2471 lasarnow@chla.usc.edu

View on ClinicalTrials.gov More Depression in Adolescence trials