Better Sleep Study

Depression in Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139861
• Other study ID #: R01MH129558-01A1
• Secondary ID: R01MH129558-01A1
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: August 1, 2028

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Lauren Asarnow, PhD
• Phone: 4159711533
• Email: Lauren.Asarnow[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Sleep Phase
• Depression
• Depression in Adolescence
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	UCSF Nancy Friend Pritzker Psychiatry Building	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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