RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-06
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06963463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adolescents (12-18)
  2. * Current moderate to severe depression as measured by the PHQ-9M with a total score of greater than or equal to 11
  3. * Current clinically significant sleep disturbance measured by the PHQ-9-M sleep item greater than or equal to 2.
  4. * English language fluency and literacy sufficient to engage in study protocol.
  1. * Evidence of obstructive sleep apnea,
  2. * Evidence of restless legs syndrome
  3. * Evidence of psychosis
  4. * Evidence of bipolar disorder
  5. * Evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening.

Contacts and Locations

Study Contact

Brandie George-Milford, MA
CONTACT
412-246-5629
georgeba2@upmc.edu
Beth Hafer
CONTACT
412-999-5051
haferbl@upmc.edu

Principal Investigator

Tina Goldstein, Ph.D
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Tina Goldstein, Ph.D, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Sleep Disturbances
  • Objective Sleep
  • Subjective Sleep Difficulties
  • Minority Youth

Additional Relevant MeSH Terms

  • Sleep Disturbance
  • Sleep
  • Depression
  • Suicide