Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT06963463
- Status
- Recruiting
Conditions
- Depression
- Sleep
- Sleep Disturbance
- Suicide
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- TranS-C — BEHAVIORALThis intervention includes participants attending 6-8 sessions with a Sleep Therapist.
- Sleep Feedback — BEHAVIORALParticipants are provided with an actigraphy watch that is used to monitor their sleep and activity throughout the day and complete a sleep diary daily. Along with wearing the watch they also will be provided access to their actigraphy and sleep diary graphs that document their data.
Study Details
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.
Key Dates
- Start date
- May 6, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Sleep FeedbackParticipants receive an actigraphy watch to track their sleep and activity levels and complete a daily sleep diary; sleep feedback graphs show participants their actigraphy watch and sleep diary data on demand.
- Experimental: TranS-C + Sleep FeedbackParticipants will attend 6-8 TranS-C sessions with a Sleep therapist. Participants will also wear bright light glasses in the morning and blue light blocking glasses in the evening throughout the intervention.
Primary Outcome Measure
Feasibility-Attendance [ Time Frame: From enrollment to the end of the treatment (up to 4 months) ]
Central Contacts
- Brandie George-Milford, MA412-246-5629
- Beth Hafer412-999-5051
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 |
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