Recruiting

TranS-C vs. Sleep Feedback

Sponsor:

University of Pittsburgh

Code:

NCT06963463

Conditions

Sleep Disturbance

Sleep

Depression

Suicide

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

TranS-C

Sleep Feedback

Study Details

Brief summary:

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.

Conditions

Sleep Disturbance

Sleep

Depression

Suicide

Study ID

NCT06963463

Start date

May 6, 2025

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep Feedback

Participants receive an actigraphy watch to track their sleep and activity levels and complete a daily sleep diary; sleep feedback graphs show participants their actigraphy watch and sleep diary data on demand.

experimental: TranS-C + Sleep Feedback

Participants will attend 6-8 TranS-C sessions with a Sleep therapist. Participants will also wear bright light glasses in the morning and blue light blocking glasses in the evening throughout the intervention.

Interventions

TranS-C

This intervention includes participants attending 6-8 sessions with a Sleep Therapist.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Childrens Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-04.