Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
NCT ID: NCT06963463
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-05-06
2027-07-31
Brief Summary
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Detailed Description
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This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinically significant sleep difficulties identified in primary care. The randomization that this study uses is a 2:1 allocation to compare TranS-C+BL Sleep Feedback vs. Sleep Feedback Alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sleep Feedback
Participants 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.
Sleep Feedback
Participants 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.
TranS-C + Sleep Feedback
Participants 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.
TranS-C
This intervention includes participants attending 6-8 sessions with a Sleep Therapist.
Sleep Feedback
Participants 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.
Interventions
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TranS-C
This intervention includes participants attending 6-8 sessions with a Sleep Therapist.
Sleep Feedback
Participants 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
18 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
University of Oregon
OTHER
National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Tina R Goldstein
Professor
Principal Investigators
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Tina Goldstein, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY22040040
Identifier Type: -
Identifier Source: org_study_id
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