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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06139861
Other study ID # R01MH129558-01A1
Secondary ID R01MH129558-01A1
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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