Sleep DisturbanceNCT06963463
Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
A study testing TranS-C and Sleep Feedback in people with Sleep Disturbance and Sleep, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Sleep Disturbance, Sleep, Depression
- What is being tested?
- TranS-C and Sleep Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jami Young, PhD, 215-590-7555, youngjf@chop.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Tina Goldstein, 412-246-5604, goldtr@upmc.edu
About this study
Official title: Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
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.
Read the detailed description
This study will adapt TranS-C+BL for at-risk adolescents using health equity-informed implementation science methods.
This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinically significant sleep difficulties identified in primary care. The randomization that this study uses is a 2:1 allocation to compare TranS-C+BL Sleep Feedback vs. Sleep Feedback Alone.
- Conditions
- Sleep Disturbance, Sleep, Depression, Suicide
- Being tested
- TranS-C, Sleep Feedback
- Keywords
- Sleep Disturbances, Objective Sleep, Subjective Sleep Difficulties, Minority Youth
- Medical subject headings
- Parasomnias, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranS-CBehavioural
This intervention includes participants attending 6-8 sessions with a Sleep Therapist.
Sleep FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Feedback | Experimental | 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. Receives: Behavioral: Sleep Feedback |
| TranS-C + Sleep Feedback | Experimental | 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. Receives: Behavioral: TranS-C; Behavioral: Sleep Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 4 month
Secondary outcomes (9)
Sleep Disturbance
Self-reported sleep disturbance will be assessed via the Pediatric PROMIS Sleep Disturbance and Sleep Related Impairment Measures. The Patient-Reported Outcomes Measurement Information System is an 8-item measure. The scoring ranges from Never (1) Almost Never (2) Sometimes (3) Almost Always (4) Always (5). The PROMIS scale is scored on the T-score metric scale. The higher the participant scores more of the concept being measured. With the general population getting a score of 50 with a standard deviation of 10
Measured: Baseline
Depression
Depressive symptom severity will be assessed via the self-reported PHQ-9-M. The Patient Health Questionnaire is a 13-item measure. The questions are rating on a 0(Not at all)- 3(Nearly Every day) Likert scale. Additional questions rated on a scale of Not difficult at all to Extremely difficult, along with yes/no questions. The PHQ-9M is rated on a scale from 0 to 27. Higher scores are associated with higher levels of, or more severe, depression
Measured: Baseline
Risk for Suicidal Thoughts and Behaviors
Suicidal thoughts and behaviors will be assessed via the C-SSRS. The Columbia-Suicide Severity Rating Scale is an 18-item measure. This measure contains yes/no questions, asking about both about suicidality over the past 3 months and lifetime. In the C-SSRS the higher the score the more risk of suicidality (0 = No risk reported (all "no" responses),1 - 2 = Low risk ,3 - 6 = Moderate to high risk)
Measured: Baseline
Sleep Disturbance
Self-reported sleep disturbance will be assessed via the Pediatric PROMIS Sleep Disturbance and Sleep Related Impairment Measures. The Patient-Reported Outcomes Measurement Information System is an 8-item measure. The scoring ranges from Never (1) Almost Never (2) Sometimes (3) Almost Always (4) Always (5). The PROMIS scale is scored on the T-score metric scale. The higher the participant scores more of the concept being measured. With the general population getting a score of 50 with a standard deviation of 10
Measured: 1 month
Sleep Disturbance
Self-reported sleep disturbance will be assessed via the Pediatric PROMIS Sleep Disturbance and Sleep Related Impairment Measures. The Patient-Reported Outcomes Measurement Information System is an 8-item measure. The scoring ranges from Never (1) Almost Never (2) Sometimes (3) Almost Always (4) Always (5). The PROMIS scale is scored on the T-score metric scale. The higher the participant scores more of the concept being measured. With the general population getting a score of 50 with a standard deviation of 10
Measured: 4 months
Depression
Depressive symptom severity will be assessed via the self-reported PHQ-9-M. The Patient Health Questionnaire is a 13-item measure. The questions are rating on a 0(Not at all)- 3(Nearly Every day) Likert scale. Additional questions rated on a scale of Not difficult at all to Extremely difficult, along with yes/no questions. The PHQ-9M is rated on a scale from 0 to 27. Higher scores are associated with higher levels of, or more severe, depression
Measured: 1 month
Depression
Depressive symptom severity will be assessed via the self-reported PHQ-9-M. The Patient Health Questionnaire is a 13-item measure. The questions are rating on a 0(Not at all)- 3(Nearly Every day) Likert scale. Additional questions rated on a scale of Not difficult at all to Extremely difficult, along with yes/no questions. The PHQ-9M is rated on a scale from 0 to 27. Higher scores are associated with higher levels of, or more severe, depression
Measured: 4 month
Risk for Suicidal Thoughts and Behaviors
Suicidal thoughts and behaviors will be assessed via the C-SSRS. The Columbia-Suicide Severity Rating Scale is an 18-item measure. This measure contains yes/no questions, asking about both about suicidality over the past 3 months and lifetime. In the C-SSRS the higher the score the more risk of suicidality (0 = No risk reported (all "no" responses),1 - 2 = Low risk ,3 - 6 = Moderate to high risk)
Measured: 1 month
Risk for Suicidal Thoughts and Behaviors
Suicidal thoughts and behaviors will be assessed via the C-SSRS. The Columbia-Suicide Severity Rating Scale is an 18-item measure. This measure contains yes/no questions, asking about both about suicidality over the past 3 months and lifetime. In the C-SSRS the higher the score the more risk of suicidality (0 = No risk reported (all "no" responses),1 - 2 = Low risk ,3 - 6 = Moderate to high risk)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start6 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Oregon, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tina R Goldstein, University of Pittsburgh
- Investigators
- Tina Goldstein, Ph.D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963463
- Sponsor's protocol ID
- STUDY22040040
- Other IDs
- P50MH115838
- Status last verified
- Jun 2026
- First submitted
- 6 May 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
- ClinicalTrials.gov ID
- NCT06963463
- Acronym / sponsor ID
- STUDY22040040
- Conditions
- Sleep Disturbance, Sleep, Depression, Suicide
- Keywords
- Sleep Disturbances, Objective Sleep, Subjective Sleep Difficulties, Minority Youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Oregon, National Institute of Mental Health (NIMH)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will adapt TranS-C+BL for at-risk adolescents using health equity-informed implementation science methods.
This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinically significant sleep difficulties identified in primary care. The randomization that this study uses is a 2:1 allocation to compare TranS-C+BL Sleep Feedback vs. Sleep Feedback Alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Feedback | Experimental | Behavioral: Sleep FeedbackParticipants 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 | Experimental | Behavioral: TranS-C, Behavioral: Sleep FeedbackParticipants 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TranS-CThis intervention includes participants attending 6-8 sessions with a Sleep Therapist. | Behavioural | TranS-C + Sleep Feedback |
| Sleep FeedbackParticipants 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. | Behavioural | Sleep Feedback, TranS-C + Sleep Feedback |
Primary outcome
Feasibility-Attendance
Time frame: From 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-Attrition
Time frame: From 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 Satisfaction
Time frame: 4 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).
9 secondary outcomes
Sleep Disturbance
Time frame: Baseline
Depression
Time frame: Baseline
Risk for Suicidal Thoughts and Behaviors
Time frame: Baseline
Sleep Disturbance
Time frame: 1 month
Sleep Disturbance
Time frame: 4 months
Depression
Time frame: 1 month
Depression
Time frame: 4 month
Risk for Suicidal Thoughts and Behaviors
Time frame: 1 month
Risk for Suicidal Thoughts and Behaviors
Time frame: 4 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Goldstein, Ph.D principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TranS-C and Sleep Feedback in people with Sleep Disturbance and Sleep, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandie George-Milford, MA (412-246-5629, georgeba2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility-Attendance (time frame: From enrollment to the end of the treatment (up to 4 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.