Health TrialsbyHealthPanel

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

ConditionsSleep DisturbanceSleepDepressionSuicide
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleep Feedback + Psychoeducation

    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+)

    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+)

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Sleep Feedback + PsychoeducationExperimental treatment 1 intervention
Group B: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Experimental treatment 2 interventions
Group C: Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Experimental treatment 3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

American Foundation for Suicide Prevention

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: