Better Sleep Study

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Delayed Sleep Phase; Depression in Adolescence

Treatments: Behavioral: TranS-C; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06139861

R01MH129558-01A1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

TranS-C

Experimental group

Treatment:

Behavioral: TranS-C

Psychoeducation

Active Comparator group

Treatment:

Behavioral: Psychoeducation