Better Sleep Study

Not Applicable

Recruiting

• Conditions: Depression in Adolescence; Delayed Sleep Phase
• Interventions: Behavioral: TranS-C; Behavioral: Psychoeducation

• Registration Number: NCT06139861
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-15
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TranS-C	TranS-C	-
Psychoeducation	Psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )	baseline to end of treatment (0 and 2 months)	Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior
Change in Children's Depression Rating Scale (CDRS-R)	baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14	Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity

Trial Locations

Locations (1)

UCSF Nancy Friend Pritzker Psychiatry Building; 🇺🇸 San Francisco, California, United States