Better Sleep Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT06139861
Status
Recruiting

Conditions

  • Delayed Sleep Phase
  • Depression in Adolescence

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 15, 2024
Status verified
May 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TranS-C
  • Active Comparator: Psychoeducation

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Lauren Asarnow, PhD
323-361-2471
Lauren Asarnow, PhD (PRINCIPAL_INVESTIGATOR)

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