Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
2 other identifiers
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedStudy Start
First participant enrolled
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
July 8, 2025
July 1, 2025
1.7 years
May 6, 2025
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility-Attendance
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.
From enrollment to the end of the treatment (up to 4 months)
Feasibility-Attrition
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.
From enrollment until withdrawal or completing treatment sessions.
Acceptability-Treatment Satisfaction
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).
4 month
Secondary Outcomes (9)
Sleep Disturbance
Baseline
Depression
Baseline
Risk for Suicidal Thoughts and Behaviors
Baseline
Sleep Disturbance
1 month
Sleep Disturbance
4 months
- +4 more secondary outcomes
Study Arms (2)
Sleep Feedback
EXPERIMENTALParticipants 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.
TranS-C + Sleep Feedback
EXPERIMENTALParticipants 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
This intervention includes participants attending 6-8 sessions with a Sleep Therapist.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Children's Hospital of Philadelphiacollaborator
- University of Oregoncollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tina Goldstein, Ph.D
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 9, 2025
Study Start
May 6, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
July 31, 2027
Last Updated
July 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Individual participant data will be available in a deidentified manner through the NIMH Data Archive indefinitely.
- Access Criteria
- Verified researchers may request the data through the NIMH Data Archive.
Consistent with the NIMH's data sharing and data use policies this research study and clinical trial will be compliant with requirements for depositing data with the NIMH Data Archive (NDA) in the National Database for Clinical Trials Related to Mental Illness (NDCT). Specific statements will be added to the consent forms to allow for data sharing. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies.