Better Sleep Study

NCT ID: NCT06139861

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2028-08-01

Brief Summary

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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

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Conditions

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Depression in Adolescence Delayed Sleep Phase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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TranS-C

Group Type EXPERIMENTAL

TranS-C

Intervention Type BEHAVIORAL

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

Psychoeducation

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type 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.

Interventions

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TranS-C

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Asarnow, PhD

Role: CONTACT

4159711533

Facility Contacts

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Fatima Gonzalez

Role: primary

Sabrina Darrow, MD

Role: backup

(415) 476-7000

Other Identifiers

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R01MH129558-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH129558-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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