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NCT Number: NCT06139861

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.

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Key information

Conditions

Depression in Adolescence Behavior Behavioral Symptoms Delayed Sleep Phase Depression

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Lauren Asarnow, PhD

CONTACT

[email protected]

323-361-2471

Lauren Asarnow, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TranS-C

Behavioral

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

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Asarnow, PhD

CONTACT

[email protected]

323-361-2471

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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