Actively Recruiting
A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents
Led by Children's Hospital Los Angeles · Updated on 2026-05-11
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital Los Angeles
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether improving the alignment between biological circadian timing and waketime can help improve depression outcomes in adolescents who have depression and a misaligned sleep-wake cycle. This study evaluates a novel target for treatment using a cognitive-behavioral sleep intervention. The trial aims to confirm the effectiveness of this approach in a carefully designed and sufficiently powered study focused on this specific subgroup of adolescents. The study compares two behavioral interventions: TranS-C, an evidence-based cognitive-behavioral sleep and circadian therapy, and Psychoeducation, which provides information on how sleep, stress, diet, health, exercise, accidents, and mood influence each other. Participants are randomly assigned to one of these two groups to assess their impact on depression and sleep timing. The treatment period lasts approximately two months. Participants will be assessed at the start and end of treatment, as well as at 8 and 14 months, using measures such as the change in phase angle difference between dim light melatonin onset (DLMO) and waketime, and the Children's Depression Rating Scale (CDRS-R). Researchers will monitor depression symptoms and sleep timing to determine changes over the study period. The trial is expected to continue through August 2028, providing long-term follow-up data.
CONDITIONS
Brief Title
Better Sleep Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 18 years
- Diagnosis of depression in adolescence
- Ability to participate in behavioral sleep therapy
- Willingness to engage in study assessments and interventions
You will not qualify if you...
- Mental health or behavioral symptoms that prevent productive participation (e.g., active psychosis, bipolar disorder, drug dependence)
- Severe or unstable medical or psychiatric conditions with recent or expected treatment changes
- Current use of medications or herbs known to affect sleep
- Planned or recent medication changes within the last 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive behavioral sleep therapy interventions to treat depression, including either Transdiagnostic Sleep and Circadian Intervention or Psychoeducation.
Weekly visits for up to 8 weeks
Duration - Up to 12 months after treatment
Participants are monitored for changes in depression and sleep-related outcomes after treatment ends.
Visits at months 8 and 14 post-treatment
Trial Site Locations
Total: 1 location
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
Research Team
L
Lauren Asarnow, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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