Improving sleep to help adolescents with depression
A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents
This study is testing if a new sleep program can help teenagers with depression feel better by improving their sleep schedule.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06139861 on ClinicalTrials.gov |
What this trial studies
This study aims to test whether enhancing the alignment between biological circadian timing and waketime can lead to better depression outcomes in adolescents suffering from depression and delayed sleep phase. It employs a cognitive-behavioral sleep intervention called TranS-C, along with psychoeducation, to address these issues. The trial is designed to be sufficiently powered to confirm the efficacy of this approach in a targeted adolescent population.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents diagnosed with depression who also experience a misalignment between their biological circadian timing and waketime.
Not a fit: Patients with severe mental health conditions such as active psychosis or bipolar disorder, or those currently using medications that affect sleep, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for adolescents struggling with depression and sleep issues.
How similar studies have performed: Other studies have shown promise in using cognitive-behavioral interventions to improve sleep and mental health outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Lauren M Asarnow, PhD — Children's Hospital Los Angeles
- Study coordinator: Lauren Asarnow, PhD
- Email: lasarnow@chla.usc.edu
- Phone: 323-361-2471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.