NCT07346014

Brief 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. 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. 1.Triple Chronotherapy (TCT)+ Transdiagnostic Sleep and Circadian Intervention (TSC)
  2. 2.Transdiagnostic Sleep and Circadian Intervention (TSC)
  3. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

January 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

January 6, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

sleep disturbancesuicidetriple chronotherapy

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (3)

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.

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.

Behavioral: Sleep Feedback + PsychoeducationBehavioral: 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.

Behavioral: Sleep Feedback + PsychoeducationBehavioral: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Behavioral: Triple Chronotherapy (TCT+)

Interventions

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.

Sleep Feedback + PsychoeducationTransdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)

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.

Triple Chronotherapy + 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)

Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Hospital/University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

ParasomniasDepressionSuicide

Interventions

Thrombin Time

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehaviorSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Tina Goldstein, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Peter Franzen

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Rice, MS

CONTACT

Tina Goldstein, PhD

CONTACT

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

January 6, 2026

First Posted

January 16, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations