Recruiting

Better Sleep Study

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.

ClinicalTrials.gov IDNCT06139861

PhaseNA

Enrollment200

SponsorChildren's Hospital Los Angeles

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Depression in Adolescence, Delayed Sleep Phase

About this study

Interventions

Behavioral: TranS-C — Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.
Behavioral: Psychoeducation — The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.

Primary outcomes

Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME ) (baseline to end of treatment (0 and 2 months))
Change in Children's Depression Rating Scale (CDRS-R) (baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14)

Eligibility information

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

Study locations

Children's Hospital Los Angeles, Los Angeles, California 90027 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.