NCT06963463 Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
| NCT ID | NCT06963463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Sleep Disturbance |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-05-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to adapt a sleep intervention for individuals representative of all demographic groups, including those who are at the highest risk for suicidal behavior. Sleep difficulties are a promising target for youth with suicidal thoughts and behavior to focus on as a prevention measure. We aim to increase intervention acceptability and impact by adapting it for the adolescent populations at highest risk for suicidal thoughts and behavior. The research project will compare Transdiagnostic Sleep and Circadian Intervention (TranS-C), an evidence based, modularized intervention that targets a range of sleep difficulties to a treatment as usual or control condition including providing weekly sleep feedback reports from data entered into a daily sleep diary and from wearing a sleep sensing, actigraphy watch. Participants in both conditions (TranS-C vs. Sleep Feedback) will wear an actigraphy sleep watch that monitors sleep, and complete daily sleep diaries via smartphone or email. Participants in the TranS-C condition will also wear bright light (BL) and blue blocking glasses each day as well as attend weekly or biweekly sessions with a Sleep Therapist. The sleep therapist will review sleep feedback during sessions.
Eligibility 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.
Contact & Investigator
Tina Goldstein, Ph.D
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06963463 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Sleep Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06963463 currently recruiting?
Yes, NCT06963463 is actively recruiting participants. Contact the research team at georgeba2@upmc.edu for enrollment information.
Where is the NCT06963463 trial being conducted?
This trial is being conducted at Philadelphia, United States, Pittsburgh, United States.
Who is sponsoring the NCT06963463 clinical trial?
NCT06963463 is sponsored by University of Pittsburgh. The principal investigator is Tina Goldstein, Ph.D at University of Pittsburgh. The trial plans to enroll 90 participants.