Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TranS-C, Sleep Feedback.
- Who it may be relevant to
- Registry conditions: Sleep Disturbance, Sleep, Depression, Suicide. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
Overview
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.
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 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.
Interventions
- Behavioral TranS-C
This intervention includes participants attending 6-8 sessions with a Sleep Therapist. - Behavioral 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.
Primary outcome measures
- Feasibility-Attendance [Time frame: From enrollment to the end of the treatment (up to 4 months)]
- Feasibility-Attrition [Time frame: From enrollment until withdrawal or completing treatment sessions.]
- Acceptability-Treatment Satisfaction [Time frame: 4 month]
Secondary outcome measures (9)
- Sleep Disturbance [Time frame: Baseline]
- Depression [Time frame: Baseline]
- Risk for Suicidal Thoughts and Behaviors [Time frame: Baseline]
- Sleep Disturbance [Time frame: 1 month]
- Sleep Disturbance [Time frame: 4 months]
- Depression [Time frame: 1 month]
- Depression [Time frame: 4 month]
- Risk for Suicidal Thoughts and Behaviors [Time frame: 1 month]
- Risk for Suicidal Thoughts and Behaviors [Time frame: 4 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Childrens Hospital of Philadelphia — Philadelphia
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06963463 · STUDY22040040 · P50MH115838