Better Sleep Study

NCT06139861 | Recruiting DMC

• 1 other identifier: R01MH129558-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Adolescence; Delayed Sleep Phase

Keywords

Depression; Adolescents; Sleep; Intervention

Outcome Measures

Primary Outcomes (2)

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

  Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior

  baseline to end of treatment (0 and 2 months)

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

  Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity

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

Study Arms (2)

TranS-C

EXPERIMENTAL

Behavioral: TranS-C

Psychoeducation

ACTIVE COMPARATOR

Behavioral: Psychoeducation

Interventions

TranS-C BEHAVIORAL

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

TranS-C

Psychoeducation BEHAVIORAL

The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.

Psychoeducation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Lauren Asarnow, PhD

CONTACT

4159711533; Lauren.Asarnow@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)