Sleep and Circadian Interventions for Suicide

(REST-UP Trial)

DR
TG
Overseen ByTina Goldstein, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how improving sleep and daily rhythms can lower the risk of suicide in young adults with severe depression. Researchers will divide participants into three groups to test different sleep-focused treatments, such as adjusting sleep schedules, using light therapy, and tracking sleep patterns. One treatment under evaluation is the Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+), which combines sleep and circadian interventions with bright light therapy. This trial suits college students who have recently had serious thoughts of self-harm and experience significant sleep issues, such as trouble falling asleep before midnight or inconsistent sleep schedules. As an unphased study, this trial provides a unique opportunity to explore innovative sleep treatments that could significantly improve mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on photosensitizing medication, you may not be eligible due to contraindications with bright light therapy.

What prior data suggests that these sleep and circadian interventions are safe for high-risk young adults?

Earlier studies have shown that triple chronotherapy (TCT+) is safe for people with depression. This method combines staying awake for a period, exposure to bright light, and adjusting sleep times. Research found that patients, including those with suicidal thoughts, handled it well and experienced rapid symptom improvement.

For the transdiagnostic sleep and circadian intervention plus bright light (TSC+), research shows it improves sleep patterns and mood in young adults, even those with suicidal thoughts. This treatment includes personalized sleep therapy and bright light exposure. While specific safety data is limited, treatments like bright light therapy are generally well-tolerated.

The sleep feedback with psychoeducation involves tracking sleep and providing feedback. Although detailed safety data is not available, sleep monitoring with feedback is considered low-risk. Overall, research supports the safety of these methods, which aim to improve sleep and mood in young adults dealing with mental health issues.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for suicide prevention because they target sleep and circadian rhythms, which are often disrupted in individuals at risk. Unlike standard options that might focus solely on medication or talk therapy, these interventions combine innovative methods like sleep deprivation, bright light therapy, and personalized sleep feedback. Triple Chronotherapy stands out with its intense initial sleep deprivation followed by controlled sleep phase advancement and light therapy, potentially offering rapid mood improvements. The Transdiagnostic Sleep and Circadian Intervention combines structured sleep therapy with light glasses to help regulate sleep patterns. These approaches aim to offer quicker and more targeted relief for those struggling with suicidal thoughts linked to sleep issues.

What evidence suggests that this trial's interventions could be effective for reducing suicide risk in young adults?

Research shows that improving sleep can help reduce suicidal thoughts and behaviors. In this trial, participants may receive one of several treatments. For those considering the Sleep Feedback + Psychoeducation treatment, studies have found that similar sleep-focused methods can lower suicidal thoughts, even when depression levels remain unchanged. Another treatment option in this trial is the Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+), which has enhanced sleep quality and reduced insomnia, leading to a better mood and a lower risk of suicide. Additionally, the Triple Chronotherapy (TCT+) treatment has quickly and significantly improved depression symptoms, which often relate to suicide risk. These treatments aim to improve sleep quality and adjust sleep patterns, which are important for managing depression and suicidal thoughts.16789

Who Is on the Research Team?

TG

Tina Goldstein, PhD

Principal Investigator

University of Pittsburgh

PF

Peter Franzen

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for college students at high risk of suicide who are fluent in English, have had suicidal thoughts or attempts in the past month, and suffer from significant sleep disturbances. They must be enrolled or planning to enroll in COSTAR Intensive Outpatient Program.

Inclusion Criteria

I am enrolled or planning to enroll in the COSTAR Intensive Outpatient Program.
I can read, write, and speak English well enough to follow study instructions.
I have not had thoughts of or attempted suicide in the past month.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Triple Chronotherapy

Participants undergo a four-day intervention including sleep deprivation, sleep phase advancement, and bright light therapy

4 days
In-person visits in a sleep lab

Transdiagnostic Sleep and Circadian Intervention

Participants attend 6-8 sessions of a manualized sleep intervention with a Sleep therapist, delivered in person or via videoconference

6-8 weeks
6-8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at short, medium, and long-term intervals

6 months
Assessments at 4 days, 2 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep Feedback + Psychoeducation
  • Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)
  • Triple Chronotherapy (TCT+)

Trial Overview

The study tests three interventions: Triple Chronotherapy plus Transdiagnostic Sleep and Circadian Intervention (TCT+TSC), just TSC, and Sleep Feedback. These are added to standard psychiatric care for depression/suicide risk to see if they lower suicide risk over a 6-month period.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Experimental Treatment3 Interventions
Group II: Transdiagnostic Sleep and Circadian Intervention + Bright Light (TSC+)Experimental Treatment2 Interventions
Group III: Sleep Feedback + PsychoeducationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

American Foundation for Suicide Prevention

Collaborator

Trials
36
Recruited
10,500+

Citations

The effect and safety of sleep interventions on suicidal ...

A large-scale evaluation found that CBT-I was associated with reduced suicidal ideation among veterans, even after accounting for changes in depression severity ...

The Impact of a Randomized Sleep Education Intervention for ...

Survey results at 8 weeks showed that more intervention subjects reported improved sleep behaviors (50.3% versus 39.5%, P = .04). Intervention subjects were ...

A systematic review and meta‐analysis on the efficacy of ...

This study aims to provide the first systematic review and meta-analysis on the efficacy of sleep interventions to treat suicidal ideation. This ...

Sleep and circadian rhythms in adolescents with attempted ...

Our results are consistent with data from the literature showing that sleep disorders are associated with an increased risk of suicide attempts ...

Effectiveness of a guided digital self-help intervention to ...

The objective of this study is to evaluate the effectiveness of the guided online 'i-Sleep & BioClock' intervention in reducing insomnia in university students ...

Sleep and Suicide Risk: A Perspective on Integrating ...

A growing body of evidence demonstrates that insomnia, nightmares, and circadian disruption are consistent and potentially modifiable correlates of suicidal ...

Dysfunctional Beliefs About Sleep in Suicidal Adolescents

DBs were studied in adolescents enrolled in a suicide prevention program. DBs were linked to sleep, depression, suicidality, and poor emotion regulation.

Sleep influences daily suicidal ideation through affective ...

Shorter-than-usual sleep predicted the presence and intensity of next-day suicidal ideation via heightened affective reactivity to negative ...

An exploratory analysis of the association of circadian rhythm ...

The current exploratory study examined the relationship of circadian rhythm dysregulation (eveningness, seasonality, and rhythmicity) with suicidality.