NCT07346014 · University of Pittsburgh
Sleep and Circadian Interventions for College Students at High Risk of Suicide
(REST-UP)
What this study is about
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.
View original scientific description
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: 1. Triple Chronotherapy (TCT)+ Transdiagnostic Sleep and Circadian Intervention (TSC) 2. Transdiagnostic Sleep and Circadian Intervention (TSC) 3. 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.
Interventions
BEHAVIORAL
Sleep Feedback + Psychoeducation
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.
BEHAVIORAL
Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)
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)
BEHAVIORAL
Triple Chronotherapy (TCT+)
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.
Primary outcome measures
Suicidal Thoughts and Behaviors via CSSRS
Time frame: (short term) Intervention Days 1-4
Columbia Suicide Severity Rating Scale, administered via clinician on Intervention Days 1-4. Range of 0-5, higher values represent higher severity/intensity
Suicidal Thoughts and Behaviors via CSSRS
Time frame: (medium term) 2 month follow up
Columbia Suicide Severity Rating Scale, administered via clinician at 2 month follow up assessment. Range of 0-5, higher values represent higher severity/intensity
Suicidal Thoughts and Behaviors via CSSRS
Time frame: (long term) 6 month follow up
Columbia Suicide Severity Rating Scale, administered via clinician at 6 month follow up assessment. Range of 0-5, higher values represent higher severity/intensity
Suicidal Thoughts and Behaviors via LIFE SI/SIB scale
Time frame: (medium term) 2mo follow up
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)
Suicidal Thoughts and Behaviors via LIFE SI/SIB scale
Time frame: (long term) 6mo follow up
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)
Depression via KSADS Depression Rating Scale
Time frame: (short term) Intervention Days 1-4
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)
Depression via KSADS Depression Rating Scale
Time frame: (medium term) 2mo follow up
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)
Depression via KSADS Depression Rating Scale
Time frame: (long term) 6mo follow up
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)
Depression via LIFE PSR
Time frame: (medium term) 2mo follow up
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)
Depression via LIFE PSR
Time frame: (long term) 6mo follow up
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where
- Pittsburgh, Pennsylvania
Collaborators
American Foundation for Suicide Prevention
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations