Sleep and Circadian Interventions for College Students at High Risk of Suicide (REST-UP)

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:

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Sleep; Sleep Disturbance; Suicide
• Intervention / Treatment: Behavioral: Sleep Feedback + Psychoeducation; Behavioral: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+); Behavioral: Triple Chronotherapy (TCT+)

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).

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tina Goldstein, PhD; Phone Number: 412-246-5604; Email: goldtr@upmc.edu
• Study Contact Backup: Name: Dawn Rice, MS; Phone Number: 412-297-1947; Email: ricedm@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Western Psychiatric Hospital/University of Pittsburgh
      • Contact: Dawn Rice, MS; Phone Number: 412-297-1947; Email: ricedm@upmc.edu
      • Contact: Tina Goldstein, MS; Email: goldtr@upmc.edu
      • Principal Investigator: Tina Goldstein, PhD
      • Principal Investigator: Peter Franzen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Feedback + Psychoeducation; 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.	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.
Experimental: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+); 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.	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)
Experimental: Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	(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	(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	(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)	(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)	(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)	(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)	(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)	(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)	(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)	(long term) 6mo follow up

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: American Foundation for Suicide Prevention
• Investigators: Principal Investigator: Tina Goldstein, PhD, University of Pittsburgh; Principal Investigator: Peter Franzen, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: suicide; sleep disturbance; triple chronotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Sleep Wake Disorders; Behavior; Suicide; Parasomnias; Depression; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Coagulation Tests; Thrombin Time
• Other Study ID Numbers: STUDY25060093; BSG-0-204-24 (Other Grant/Funding Number: American Foundation for Suicide Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No