Clinical trial NCT06963463: Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
Official title: Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Sleep
Depression
Suicide
Keywords: Sleep Disturbances
Objective Sleep
Subjective Sleep Difficulties
Minority Youth
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Oregon
name: National Institute of Mental Health (NIMH)
First posted: 2025-05-09
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Suicide is the second leading cause of death in youth, and recent statistics indicate disproportionate risk for suicidal behavior among Black youth. Despite this, few interventions effectively prevent youth suicidal thoughts and behaviors (STB). Sleep difficulties may be a particularly promising target for youth STB prevention efforts. To date, no intervention targeting sleep difficulties have been examined among youth at-risk for STBs nor tailored to Black youth; this research is critical for maximizing intervention acceptability and impact.

The Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence-based, modularized intervention that targets a range of sleep and circadian difficulties, making it especially well-suited for treating adolescent sleep. Delivery of this intervention will be through telehealth with a Sleep Therapist. Youth will wear an actigraphy watch that monitors sleep and will complete daily sleep diaries via smartphone or email; sleep feedback reports of sleep diary and actigraphy data are available on demand after completing a diary entry. The adolescents will also wear bright light glasses in the morning and blue light blocking glasses in the evening. Adolescents will also attend weekly or biweekly sessions with a Sleep Therapist. The Sleep Therapist will review sleep feedback generated from actigraph and sleep diary data with adolescents during sessions.

In the Sleep Feedback alone intervention, adolescents will wear an actigraphy watch and complete daily diaries; they are able to view their sleep feedback on demand through user-friendly graphs of naturalistic objective and subjective sleep data.

Detailed description: The Study proposes to adapt TranS-C for at-risk adolescents using health equity-informed implementation science methods.

In this randomized trial we 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+Sleep Feedback vs. Sleep Feedback Alone.

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.

Primary outcomes:
measure: Feasibility-Attendance
timeFrame: From enrollment to the end of the treatment (up to 4 months)
measure: Feasibility-Attrition
timeFrame: From enrollment until withdrawal or completing treatment sessions.
measure: Acceptability-Treatment Satisfaction
timeFrame: 4 month
Secondary outcomes:
measure: Sleep Disturbance
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Risk for Suicidal Thoughts and Behaviors
timeFrame: Baseline
measure: Sleep Disturbance
timeFrame: 1 month
measure: Sleep Disturbance
timeFrame: 4 months
measure: Depression
timeFrame: 1 month
measure: Depression
timeFrame: 4 month
measure: Risk for Suicidal Thoughts and Behaviors
timeFrame: 1 month
measure: Risk for Suicidal Thoughts and Behaviors
timeFrame: 4 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tina Goldstein, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: