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Идёт набор NCT06593379

Mobile Intervention for Suicidal Thoughts

Без фазы С лечением 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: Safety planning, Treatment as usual, MIST Intervention.
Кому может быть актуально
Состояния в реестре: 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
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Официальное название

Pilot Randomized Controlled Trial of the Mobile Intervention for Suicidal Thoughts

Обзор

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions that been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

Подробное описание

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions, including hopelessness, thwarted belongingness, perceived burdensomeness, unlovability, unbearability, and unsolvability. These cognitions have all been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

The investigators will conduct a pilot randomized controlled trial (RCT), in which 50 Veterans with suicidal ideation will be randomized to either MIST plus Treatment as Usual and Safety Planning versus Treatment as Usual and Safety Planning. The central hypothesis is that Veterans will find MIST acceptable and will be willing to use it to reduce their suicidal thoughts.

Вмешательства

  • Поведенческое Safety planning
    Safety planning (SP) is a single-session intervention that consists of developing a written list of individualized coping strategies and sources of support that can be used during a suicidal crisis.
  • Поведенческое Treatment as usual
    This will include continued care with any of the Veterans' current providers. Study staff will also place appropriate referrals for Veterans, as needed (e.g., Trauma Recovery Program referrals for Veterans with PTSD, Sleep Psychology referrals for Veterans with insomnia). Participants will be encouraged to follow up with their providers' recommendations and treatment plans
  • Поведенческое MIST Intervention
    This is a mobile intervention designed to target and modify suicidal cognitions. Veteran in this condition will be asked to use the intervention 5 times a week for 4 weeks.

Первичные конечные точки

  • Number of participants recruited [Срок оценки: Through study completion (approximately 18 months)]
  • Percentage of enrolled participants who complete the study intervention [Срок оценки: Post-treatment visit (approximately one month after enrollment)]
  • Patient satisfaction for MIST app: Client Satisfaction Questionnaire [Срок оценки: Post-treatment visit (approximately one month after enrollment)]
  • MIST intervention utilization [Срок оценки: Post-MIST assessment visit (approximately one month after enrollment)]

Критерии участия

Критерии включения

  • Veterans using the Durham VA Health Care System
  • Endorsing suicidal ideation without intent in the last 30 days, established via C-SSRS
  • Meet at least every 4 months with a mental health provider, established via chart review chart
  • Can read at least 6th grade level material, established by their demonstrated ability to read the consent form and answer basic questions about it

Критерии исключения

  • Currently in a period of active psychosis or mania, established via the SCID-5
  • Currently meeting criteria for a moderate or severe alcohol or substance use disorder, established via the SCID-5
  • Endorsing suicidal intent, established via C-SSRS
  • Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
  • Have used the MIST intervention before as part of another research study

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Durham VA Medical Center, Durham, NC — Durham

Идентификаторы

NCT: NCT06593379 · D5137-P

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗