RecruitingNot Applicable

Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)

United States90 participantsStarted 2025-05-06

Plain-language 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.

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility-Attendance

Timeframe: From enrollment to the end of the treatment (up to 4 months)

Feasibility-Attrition

Timeframe: From enrollment until withdrawal or completing treatment sessions.

Acceptability-Treatment Satisfaction

Timeframe: 4 month

Trial details

NCT IDNCT06963463

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Brandie George-Milford, MA

412-246-5629 georgeba2@upmc.edu

View on ClinicalTrials.gov More Sleep Disturbance trials