Sleep DisturbanceREST-UPNCT07346014
Sleep and Circadian Interventions for College Students at High Risk of Suicide
A study testing Sleep Feedback + Psychoeducation, Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+) and Triple Chronotherapy (TCT+) in people with Sleep Disturbance and Sleep, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to examine the extent to which delivering sleep and circadian focused interventions in addition to evidenced based psychiatric care for depression and suicide risk may contribute to decreasing suicide risk among high risk young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Sleep Disturbance, Sleep, Depression
- What is being tested?
- Sleep Feedback + Psychoeducation, Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+) and Triple Chronotherapy (TCT+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to Mar 2029
- Phase
- Interventional
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Enrolled or planning to enroll in treatment at COSTAR Intensive Outpatient Program
- English language fluency and literacy sufficient to engage in study protocol
- Suicidal ideation or suicide attempt in past month
- Clinically significant sleep disturbance, operationalized as Pittsburgh Sleep Quality Index global PSQI score >= 7, and/or delayed bedtimes (>midnight), and/or >2 hours in sleep timing variability
Who cannot join
- Non-affective psychosis per electronic health record (EHR) review and/or baseline clinical assessment, or symptom severity or psychosocial functioning impairments that preclude participation
- Contraindications for either sleep deprivation or bright light therapy (e.g., bipolar disorder; seizure disorder; photosensitizing medication)
- Intellectual disability precluding comprehension of study procedures
- Evidence of untreated obstructive sleep apnea and/or restless legs syndrome
- Life-threatening medical condition requiring immediate treatment (such as cancer; end stage disease)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Dawn Rice, MS, 412-297-1947, ricedm@upmc.edu
Tina Goldstein, MS, goldtr@upmc.edu
About this study
Official title: Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention (TSC+) for Suicidal Young Adults
The purpose of this study is to examine the extent to which delivering sleep and circadian focused interventions in addition to evidenced based psychiatric care for depression and suicide risk may contribute to decreasing suicide risk among high risk young adults. Investigators will evaluate three interventions targeting sleep in acutely suicidal college students enrolled in intensive outpatient treatment. Participants will be randomly assigned to one of three intervention groups:
- Triple Chronotherapy (TCT)+ Transdiagnostic Sleep and Circadian Intervention (TSC)
- Transdiagnostic Sleep and Circadian Intervention (TSC)
- Sleep Feedback (SF) Participants will be followed for 6 months with primary outcome domains of suicidal thoughts and behaviors and depression evaluated by blinded clinicians at short (Days 1-4 of intervention), medium (2 months) and long (6 month) term intervals.
Read the detailed description
Suicide is currently the second leading cause of death among college students, and suicidal thoughts and behaviors (STBs) in this group have increased substantially in recent years. Indeed, young adulthood represents a particularly high-risk period for onset of psychiatric disorders associated with STBs, including depression, anxiety, and substance use disorder. There is a pressing need for efficacious treatments for suicidal college students that yield fast-acting and sustained effects in order to minimize disruption to young adults' developmental trajectories. While efficacious treatments exist to decrease suicide risk, effects generally take months. Interventions that rapidly improve suicidality are thus urgently needed. Triple chronotherapy (TCT) is a candidate, as two open studies documented dramatic reductions in suicidality. TCT is a 4-5 day intervention that involves one day and night of sleep deprivation, followed by 4 nights of sleep advance of bed/waketimes combined with morning bright light therapy (presumed to both advance the circadian rhythm and improve mood). Randomized control trials indicate that TCT rapidly improves depression, though suicide-specific randomized control trials have not been conducted to date. The investigators will thus propose to examine TCT as a means to rapidly reduce suicidality, but to also pair this with a multidimensional sleep health intervention (i.e., the Transdiagnostic Sleep and Circadian Intervention, TSC) to test whether this will help sustain improvements. Investigators assert that a "TCT+" package that includes TCT (4-day protocol) followed by TSC+ (6-8 outpatient sessions) holds promise to safely and non-invasively yield rapid and sustained improvement in depression and STBs among suicidal college students. This study is a 3-arm RCT comparing TCT+ vs TSC+ Alone vs Sleep Feedback (Ctrl) in 90 acutely suicidal college students, ages 18-25 years, reporting sleep difficulties and receiving Intensive Outpatient Program (IOP) treatment. The investigators will examine trajectories of depression and suicidality over short- (i.e., 4 days), medium- (i.e., 2 months), and long-term (i.e., 6 months).
- Conditions
- Sleep Disturbance, Sleep, Depression, Suicide
- Being tested
- Sleep Feedback + Psychoeducation, Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+), Triple Chronotherapy (TCT+)
- Keywords
- sleep disturbance, suicide, triple chronotherapy
- 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.
Sleep Feedback + PsychoeducationBehavioural
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 on demand via smartphone link.
Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Behavioural
Behavioral: TSC+
- This intervention includes participants attending 6-8 sessions of a manualized sleep intervention with a Sleep Therapist, delivered in person or videoconference, as well as daily bright light therapy (up to one hour daily) and blue light blocking glasses (up to one hour before bedtime)
Triple Chronotherapy (TCT+)Behavioural
Behavioral: TCT+
- One night of total sleep deprivation followed by three nights of sleep phase advancement in the sleep lab, daily bright light therapy (up to one hour daily) and blue light blocking glasses (up to one hour before bedtime), in a sleep lab.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Feedback + Psychoeducation | 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 + Psychoeducation |
| Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+) | Experimental | Participants will attend 6-8 TSC sessions of a manualized sleep intervention with a Sleep therapist, delivered in person or videoconference. Participants will also wear bright light glasses (up to 60 minutes) in the morning and blue light blocking glasses in the evening throughout the intervention.
Additionally, 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 + Psychoeducation; Behavioral: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+) |
| Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+) | Experimental | TCT+ Participants receive a four-day intervention, beginning with an approximately 33-hour total sleep deprivation period, followed by 3-days of sleep phase advancement and daily bright light therapy (up to sixty minutes) in the morning and blue light blocking glasses (up to one hour before bedtime) in the evening, in a sleep lab.
TSC+ Participants will also attend 6-8 TSC sessions of a manualized sleep intervention with a Sleep therapist, delivered in person or videoconference. Participants will continue to wear bright light glasses (up to sixty minutes daily) in the morning and blue light blocking glasses (up to one hour before bedtime) in the evening throughout the intervention.
SF 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 + Psychoeducation; Behavioral: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+); Behavioral: Triple Chronotherapy (TCT+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Thoughts and Behaviors via CSSRS
Columbia Suicide Severity Rating Scale, administered via clinician on Intervention Days 1-4. Range of 0-5, higher values represent higher severity/intensity
Measured: (short term) Intervention Days 1-4
Suicidal Thoughts and Behaviors via CSSRS
Columbia Suicide Severity Rating Scale, administered via clinician at 2 month follow up assessment. Range of 0-5, higher values represent higher severity/intensity
Measured: (medium term) 2 month follow up
Suicidal Thoughts and Behaviors via CSSRS
Columbia Suicide Severity Rating Scale, administered via clinician at 6 month follow up assessment. Range of 0-5, higher values represent higher severity/intensity
Measured: (long term) 6 month follow up
Suicidal Thoughts and Behaviors via LIFE SI/SIB scale
The Longitudinal Interval Follow-Up Evaluation (LIFE) Self Injurious/Suicidal Behaviors Measure, administered by clinician at the 2-month assessment (LIFE SI/SIB Range 0-5, higher number indicates greater lethality)
Measured: (medium term) 2mo follow up
Suicidal Thoughts and Behaviors via LIFE SI/SIB scale
The Longitudinal Interval Follow-Up Evaluation (LIFE) Self Injurious/Suicidal Behaviors Measure, administered by clinician at the 6-month assessment (LIFE SI/SIB Range 0-5, higher number indicates greater lethality)
Measured: (long term) 6mo follow up
Depression via KSADS Depression Rating Scale
The Kiddie Schedule for Affective Disorders and Schizophrenia-Depression Rating Scale, administered via clinician at Intervention Days 1-4. (KDRS Range 0-64 with higher scores indicating greater severity)
Measured: (short term) Intervention Days 1-4
Depression via KSADS Depression Rating Scale
The Kiddie Schedule for Affective Disorders and Schizophrenia-Depression Rating Scale, administered via clinician at 2 month follow up. (KDRS Range 0-64 with higher scores indicating greater severity)
Measured: (medium term) 2mo follow up
Depression via KSADS Depression Rating Scale
The Kiddie Schedule for Affective Disorders and Schizophrenia-Depression Rating Scale, administered via clinician at 6 month follow up. (KDRS Range 0-64 with higher scores indicating greater severity)
Measured: (long term) 6mo follow up
Depression via LIFE PSR
The Longitudinal Interval Follow-Up Evaluation (LIFE) Psychiatric Status Ratings, administered by clinician at the 2 month assessment (PSR; Range 1-6, higher numbers indicate greater severity)
Measured: (medium term) 2mo follow up
Depression via LIFE PSR
The Longitudinal Interval Follow-Up Evaluation (LIFE) Psychiatric Status Ratings, administered by clinician at the 6 month assessment (PSR Range 1-6, higher numbers indicate greater severity)
Measured: (long term) 6mo follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 Jun 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (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
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Tina R Goldstein, University of Pittsburgh
- Investigators
- Tina Goldstein, PhD, Principal investigator, University of PittsburghPeter Franzen, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346014
- Sponsor's protocol ID
- STUDY25060093
- Other IDs
- BSG-0-204-24
- Acronym
- REST-UP
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No