Status:
RECRUITING
Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Children's Hospital of Philadelphia
University of Oregon
Conditions:
Sleep Disturbance
Sleep
Eligibility:
All Genders
12-18 years
Phase:
NA
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 diff...
Detailed Description
This study will adapt TranS-C+BL for at-risk adolescents using health equity-informed implementation science methods. This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06963463
Start Date
May 6 2025
End Date
July 31 2027
Last Update
July 8 2025
Active Locations (2)
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1
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213