Better Sleep Study

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06139861

Collaborator

Stanford University (Other)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression in Adolescence Delayed Sleep Phase	Behavioral: TranS-C Behavioral: Psychoeducation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2028

Anticipated Study Completion Date :

Aug 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TranS-C	Behavioral: TranS-C Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.
Active Comparator: Psychoeducation	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.

Arm

Intervention/Treatment

Experimental: TranS-C

Behavioral: TranS-C

Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.

Active Comparator: Psychoeducation

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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