Transdiagnostic Sleep and Circadian Intervention + Bright Light for Depression in Adolescents

This study is testing a new way to help adolescents (ages 12-18) who have depression and sleep problems. It's called Transdiagnostic Sleep and Circadian Intervention (TranS-C) and involves 6-8 sessions with a sleep therapist. Participants will also wear a watch to track their sleep and keep a daily sleep diary. The goal is to see if this intervention can improve sleep and help prevent suicidal thoughts and behaviors in young people. To join, you need to have moderate to severe depression and significant sleep difficulties. The study will look at how easy it is to attend sessions, how many people complete the treatment, and how satisfied participants are with the treatment over about four months. The study aims to enroll 90 participants.

Study design
This is an interventional study that will randomly assign participants to either receive TranS-C + Sleep Feedback or Sleep Feedback alone. It plans to enroll 90 adolescents.
What's involved
You would attend 6-8 sessions with a sleep therapist, wear an actigraphy watch to monitor sleep, and complete a daily sleep diary. The treatment period is up to 4 months.
Compensation
Not stated in the trial record.
Follow-up
The study measures treatment satisfaction at 4 months, which suggests follow-up until that point.

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NCT06963463

Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)

Recruiting
NAAges 12–18InterventionalTreatment
University of Pittsburgh
~90 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:TranS-CSleep Feedback

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility-Attendance
Measured over From enrollment to the end of the treatment (up to 4 months)
+2 more outcomes measured
Sleep Disturbance
Sleep
Depression
Suicide
2 sites across 1 states
Pennsylvania2
  • Tina Goldstein, Ph.D · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

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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.
  • Feasibility-AttendanceFrom enrollment to the end of the treatment (up to 4 months)

    Feasibility of interventions as by measured by the mean of number of sessions attended. Local study documents are used to track each session that was completed.

  • Feasibility-AttritionFrom enrollment until withdrawal or completing treatment sessions.

    Attrition will be assessed using a study-specific form reflecting participants who withdraw or are withdrawn from the TranS-C+ intervention. The proportion of patients who withdraw or are withdrawn will be calculated.

  • Acceptability-Treatment Satisfaction4 month

    Treatment satisfaction will be measured by the patient-reported Treatment Satisfaction Questionnaire administered post-treatment. The Treatment Satisfaction Questionnaire assesses satisfaction with the treatment received and perception of progress; each item is rated on a Likert scale. Additional open-ended questions allow for participants to share feedback on strengths and weaknesses as well as any other feedback related to their satisfaction with the intervention. The Questionnaire has questions on a 1(Not at all)-7(Very Much). Questions on study clinicians are asked on a 1(Poor)-7(Superior) Likert scale. Questions on the duration of study on a 1(Much too short)-7(Much to long) Likert scale. Questions about frequency of visits on a 1(Much too infrequent)-7(Much to frequent). Questions for recommendations to other rated on a 1(Strongly recommend)-7(Strongly not recommend). Questions on future outlook rated on a 1(Very Pessimistic)-7(Very Optimistic).