Sleep and bright-light program for teens with depression and sleep problems
Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
This project will try a sleep-and-bright-light program to improve sleep and mood in teens aged 12–18 with moderate-to-severe depression and clinically significant sleep problems who are at risk for suicidal thoughts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06963463 on ClinicalTrials.gov |
What this trial studies
This randomized study adapts a modular Transdiagnostic Sleep and Circadian Intervention (TranS-C) with bright light (TranS-C+BL) for adolescents at elevated risk for suicidal thoughts and clinically significant sleep disturbance. Seventy-five youth aged 12–18 identified in primary care will be randomized 2:1 to TranS-C+BL plus sleep feedback versus sleep feedback alone. All participants will wear an actigraphy watch and complete daily sleep diaries to provide objective and subjective sleep data while the team uses health-equity implementation methods to tailor the intervention for diverse and high-risk populations. Primary outcomes include sleep measures, depressive symptoms, and suicidal thoughts/behaviors collected over the intervention period.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adolescents aged 12–18 with moderate-to-severe depression (PHQ-9 ≥11), clinically significant sleep disturbance, and identified as at-risk for suicidal thoughts or behaviors.
Not a fit: Patients with untreated obstructive sleep apnea, restless legs syndrome, psychosis, bipolar disorder, or developmental disabilities that preclude understanding procedures are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve sleep and reduce depressive symptoms and suicidal thoughts in at-risk adolescents.
How similar studies have performed: TranS-C is an evidence-based modular sleep intervention that has shown benefits for sleep and some mood outcomes, but combining it with bright-light therapy and adapting it specifically for high-risk adolescents is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescents (12-18) * Current moderate to severe depression as measured by the PHQ-9M with a total score of greater than or equal to 11 * Current clinically significant sleep disturbance measured by the PHQ-9-M sleep item greater than or equal to 2. * English language fluency and literacy sufficient to engage in study protocol. Exclusion Criteria: * Evidence of obstructive sleep apnea, * Evidence of restless legs syndrome * Evidence of psychosis * Evidence of bipolar disorder * Evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening.
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Tina Goldstein, Ph.D — University of Pittsburgh
- Study coordinator: Brandie George-Milford, MA
- Email: georgeba2@upmc.edu
- Phone: 412-246-5629
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.