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Recruiting NCT06139861

Better Sleep Study

No phase Interventional Depression in Adolescence Delayed Sleep Phase

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TranS-C, Psychoeducation.
Who it may be relevant to
Registry conditions: Depression in Adolescence, Delayed Sleep Phase. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME ) [Time frame: baseline to end of treatment (0 and 2 months)]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Hospital Los Angeles — Los Angeles

Identifiers

NCT: NCT06139861 · CHLA-25-00351 · R01MH129558-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗