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

Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests sleep therapy with bright light and blue-blocking glasses for teens ages 12–18 who have depression and sleep problems. It compares this treatment with weekly sleep feedback. Both groups wear a sleep-tracking watch and keep a daily sleep diary.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 12–18.
  • Have moderate to severe depression, with a score of 11 or higher on the PHQ-9M depression survey.
  • Have significant sleep problems, with a score of 2 or higher on the survey’s sleep question.
  • Can speak and read English well enough to take part.

Who can't join

  • Signs of obstructive sleep apnea, when breathing is blocked during sleep.
  • Signs of restless legs syndrome, which causes an urge to move the legs.
  • Signs of psychosis, such as seeing or hearing things that are not there.
  • Signs of bipolar disorder, which causes major changes in mood and energy.
  • A developmental disability that prevents understanding the study steps, based on health records and screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

PA