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Набор по приглашению NCT05847504

mHealth-supported Skills Training for Alcohol-Related Suicidality

Без фазы С лечением Alcohol Drinking Suicide

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: mSTARS.
Кому может быть актуально
Состояния в реестре: Alcohol Drinking, Suicide. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Successive Cohort Design to Iteratively Develop mSTARS

Обзор

Suicide is a high priority public health problem and an increasingly prevalent alcohol-related consequence. One-third of people who die by suicide consume alcohol at hazardous rates in the year preceding death. Most people in an acute suicide crisis who present for treatment are admitted to acute psychiatric hospitalization. Yet, the 30-day period following discharge from hospitalization is by far the riskiest period for another suicide crisis. The specific aim for this project is to use a successive cohort design to iteratively develop an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). The study team will adapt and iteratively refine a cognitive-behavioral skills training intervention in emotion regulation to be administered in an acute care setting and paired with a post-discharge mHealth app that encourages application of these skills to real life. Two cohorts of five participants each will be enrolled in the project. Participants will complete mSTARS, an intervention that combines inpatient skills training and the mHealth telephone app. Upon completion of the 30-day period, participants will complete self-report measures and participate in an interview designed to evaluate their experience with the mSTARS intervention.

Подробное описание

Suicide is a high priority public health problem and an increasingly prevalent alcohol-related consequence. One-third of people who die by suicide consume alcohol at hazardous rates in the year preceding death. Most people in an acute suicide crisis who present for treatment are admitted to acute psychiatric hospitalization. Yet, the 30-day period following discharge from hospitalization is by far the riskiest period for another suicide crisis, (post-discharge rates of suicide are 600 times the global rate). Critically, 50% of suicidal inpatients report alcohol misuse, which further heightens post-discharge risk for suicide.

Acute psychiatric hospitalization focuses on rapid crisis resolution before discharging patients back into their environments with a referral for outpatient care. Outpatient-based cognitive-behavioral skills training in emotion regulation successfully treats concurrent alcohol misuse and suicidal behavior by targeting deficits in emotion regulation associated with both behaviors. Yet, fewer than 50% of psychiatric inpatients follow up with outpatient care once discharged, and those who seek care are often unable to receive it for weeks. Persistently low use of outpatient therapies coupled with alarming post-discharge rates of suicide represents an urgent quality gap. Alternative strategies for inpatient care that extend treatment into the critical post-discharge period are clearly needed to prevent suicide in psychiatric inpatients who misuse alcohol.

The specific aim for this project is to use a successive cohort design to iteratively develop an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). The study team will adapt and iteratively refine a cognitive-behavioral skills training intervention in emotion regulation to be administered in an acute care setting and paired with a post-discharge mHealth app that encourages application of these skills to real life.

Two cohorts of five participants each will be enrolled in the project. Participants will complete mSTARS, an intervention that combines inpatient skills training and the mHealth telephone app. Inpatient skills training will be completed while participants are receiving inpatient psychiatric treatment. Skills training includes content designed to improve emotional regulation skills, including motivational enhancement, emotional awareness and acceptance, thinking flexibly, changing emotions, countering cravings, and relapse prevention. Upon discharge from Duke's inpatient program, patients will download the mHealth app on their personal phones to use in the personal environments for 30 days. The app is designed to encourage participants to apply skills acquired in inpatient skills training to real-life situations. Upon completion of the 30-day period, participants will complete self-report measures and participate in a semi-structured qualitative interview designed to evaluate their experience with the mSTARS intervention.

Вмешательства

  • Поведенческое mSTARS
    mSTARS combines inpatient cognitive-behavioral skills training and outpatient use of a mobile app encouraging application of acquired skills to real life situations.

Первичные конечные точки

  • Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire. [Срок оценки: 30 days]
  • Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire [Срок оценки: 30 days]
  • Number of participants who score 54 or more on a measure of emotion regulation skills use. [Срок оценки: 30 days]
Вторичные конечные точки (7)
  • Number of participants who score above clinical range on an emotion regulation scale [Срок оценки: 30 Days]
  • Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90 [Срок оценки: 30 days]
  • Average score on the Beck Scale for Suicidal Ideation [Срок оценки: 30 days]
  • Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol [Срок оценки: 30 days]
  • Number of participants who score 21 or less on the Brief Inventory of Psychosocial Functioning [Срок оценки: 30 days]
  • Average number of drinking days [Срок оценки: 30 days]
  • Number of participants who report re-hospitalization to an inpatient psychiatry unit. [Срок оценки: 30 days]

Критерии участия

Критерии включения

  • Age 18+
  • hospitalized for suicide crisis at Duke BHIP
  • an AUDIT-C score indicating hazardous past-month drinking (4 for men; 3 for women) + a 90-day calendar timeline follow-back (TLFB) indicating a minimum of 3 heavy drinking days per week on average (per NIAAA standards)
  • owns a smart phone
  • fluent in English.

Критерии исключения

  • current psychotic or mania symptoms indicated by the MINI Neuropsychiatric Interview 6.0.(MINI)
  • receiving ECT at the time of hospitalization, which could inhibit learning
  • engaged in weekly outpatient psychotherapy
  • discharging to another high level of psychiatric care.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Duke School of Medicine — Durham

Идентификаторы

NCT: NCT05847504 · Pro00113104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗