ClinicalTrials.gg
RecruitingNCT07346014REST-UPUpdated Jul 7, 2026

Sleep and Circadian Interventions for College Students at High Risk of Suicide

An interventional study of Sleep Feedback + Psychoeducation and Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+) in Sleep Disturbance, Sleep and Depression, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 105 studies in Depression by University of Pittsburgh — 15 open to participants now, 17 under way, none of them phase 3. Depression · University of Pittsburgh.

Planned enrollment
48th of 98
90 · median 90
Started
2026
with 2 others
No phase
72 of 105
15 open now
Primary completion
2029-03
later than 12 of 16 live
Registered
104th of 105
by date

Among the 105 studies in Depression by University of Pittsburgh, this one is the 48th largest by planned enrollment of the 98 interventional ones, is one of 3 that started in 2026, is one of 72 with no phase, reaches primary completion later than 12 of the 16 other live ones, and was the 104th registered.

By phase

105 studies; the count open now beside each. This study's row is marked.

No phasethis study72 · 15 open
Phase 415 · 0 open
Observational6 · 0 open
Phase 2/34 · 0 open
Phase 33 · 0 open
Phase 12 · 0 open
Phase 22 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 1983; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 90 across the 98 interventional studies, 80 across the 6 observational. Of the 85 that completed or were terminated, 29 (34%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 105 studies in Depression by University of Pittsburgh, or all of them as a file.
02

Study 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. 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.
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).

03

Conditions studied

  • Sleep Disturbance
  • Sleep
  • Depression
  • Suicide

Keywords

  • sleep disturbance
  • suicide
  • triple chronotherapy
04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • 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

  • 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 · Behavioral: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)

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

Interventions

  • BehavioralSleep 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.

  • BehavioralTransdiagnostic 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)

  • BehavioralTriple 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: (short term) Intervention Days 1-4

  2. 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

    Time frame: (medium term) 2 month follow up

  3. 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

    Time frame: (long term) 6 month follow up

  4. 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)

    Time frame: (medium term) 2mo follow up

  5. 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)

    Time frame: (long term) 6mo follow up

  6. 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)

    Time frame: (short term) Intervention Days 1-4

  7. 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)

    Time frame: (medium term) 2mo follow up

  8. 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)

    Time frame: (long term) 6mo follow up

  9. 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)

    Time frame: (medium term) 2mo follow up

  10. 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)

    Time frame: (long term) 6mo follow up

07

Study locations

1 of 1 sites recruiting
  • Western Psychiatric Hospital/University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
    • Dawn Rice, MS · Contactricedm@upmc.edu · 412-297-1947
    • Tina Goldstein, MS · Contactgoldtr@upmc.edu
    • Tina Goldstein, PhD · Principal investigator
    • Peter Franzen, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Mar 2029, 33 months after the start.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 33 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2026
First posted
Jan 16, 2026
StartActual
Jun 18, 2026
Primary completionEst.
Mar 2029
CompletionEst.
Mar 2029
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07346014
Collaborators
American Foundation for Suicide Prevention
Responsible party
Tina R Goldstein (Professor, University of Pittsburgh) — Principal investigator
First posted
Jan 16, 2026
Start date
Jun 18, 2026
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Jul 7, 2026

Study contacts

Dawn Rice, MS
Contact
ricedm@upmc.edu
412-297-1947
Tina Goldstein, PhD
Contact
goldtr@upmc.edu
412-246-5604
Tina Goldstein, PhD
principal investigator · University of Pittsburgh
Peter Franzen
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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