What this study is
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.
What's being tested
- Sleep Feedback + Psychoeducation
Intervention · BEHAVIORAL
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+)
Intervention · BEHAVIORAL
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+)
Intervention · BEHAVIORAL
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 details
- Official title
- Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention (TSC+) for Suicidal Young Adults
- Sponsor
- University of Pittsburgh
- Conditions
- Sleep Disturbance · Sleep · Depression · Suicide
- Enrolling
- 90 people
- Starts
- 2026-06-18
- Est. completion
- 2029-03
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 25 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWestern Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Dawn Rice, MS · Contact412-297-1947ricedm@upmc.edu
- Tina Goldstein, MS · Contactgoldtr@upmc.edu
- Tina Goldstein, PhD · Principal investigator
- Peter Franzen, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Pittsburgh
Study ID STUDY25060093
Principal investigator
Tina Goldstein, PhD
University of Pittsburgh
Principal investigator
Peter Franzen
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.