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

Официальное название

Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention (TSC+) for Suicidal Young Adults

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое Sleep 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.
• Поведенческое 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)
• Поведенческое Triple 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.

Первичные конечные точки

• Suicidal Thoughts and Behaviors via CSSRS [Срок оценки: (short term) Intervention Days 1-4]
• Suicidal Thoughts and Behaviors via CSSRS [Срок оценки: (medium term) 2 month follow up]
• Suicidal Thoughts and Behaviors via CSSRS [Срок оценки: (long term) 6 month follow up]
• Suicidal Thoughts and Behaviors via LIFE SI/SIB scale [Срок оценки: (medium term) 2mo follow up]
• Suicidal Thoughts and Behaviors via LIFE SI/SIB scale [Срок оценки: (long term) 6mo follow up]
• Depression via KSADS Depression Rating Scale [Срок оценки: (short term) Intervention Days 1-4]
• Depression via KSADS Depression Rating Scale [Срок оценки: (medium term) 2mo follow up]
• Depression via KSADS Depression Rating Scale [Срок оценки: (long term) 6mo follow up]
• Depression via LIFE PSR [Срок оценки: (medium term) 2mo follow up]
• Depression via LIFE PSR [Срок оценки: (long term) 6mo follow up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Western Psychiatric Hospital/University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07346014 · STUDY25060093 · BSG-0-204-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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