Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Обзор

The goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive Brief Cognitive Behavioral Therapy (BCBT) as a first-line treatment. The main aims of the study are: * Aim 1: To develop a novel treatment prognostic calculator to predict response to treatment as usual (TAU) and identify treatment-seeking military personnel who are unlikely to respond adequately to TAU for the reduction of suicidal ideation. * Aim 2: To evaluate the performance of the treatment prognosis calculator in a new sample of treatment-seeking military personnel and determine whether BCBT is more effective than TAU for those patients who are predicted not to respond adequately to TAU. Participants will receive mental health treatment as it is typically administered by their mental healthcare treatment team. Members of their mental healthcare treatment team may receive intensive training in BCBT. After their provider has received this training, they may use this treatment as part of standard of care treatment. The timing of this training will be determined randomly. Participants will complete self-report assessments at the beginning of the study (baseline) as well as 3, 6, 9 and 12 months after their participant begins. These assessments will include questions about feelings, thoughts, moods, impulses, substance use, and behavior.

Вмешательства

• Поведенческое Brief Cognitive Behavioral Therapy (BCBT)
  BCBT was developed to provide patients with the skills they need to better manage the cognitive, emotional, physiological, and behavioral components of acute suicidal crises.
• Поведенческое Treatment as usual (TAU)
  Behavioral health treatment as it is typically provided at the treatment site.

Первичные конечные точки

• Suicidal Ideation [Срок оценки: 6 Months]

Вторичные конечные точки (3)

• Suicide Attempts [Срок оценки: 12 Months]
• Depression [Срок оценки: 12 Months]
• Hopelessness [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• female and male active duty service members;
• => 18 years old;
• engaged in mental health treatment at one of the sites at study enrollment;
• score >0 on the Columbia Suicide Severity Rating Scale (CSSRS) Screener-Recent, or indicated suicidal ideation on questions 4 or 5 of the Scale for Suicidal Ideation, indicating suicidal ideation within the last month;
• able to understand and speak English;
• able to provide consent.

Критерии исключения

(1) participants with a psychiatric or medical condition that prevents them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication).

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

Профилактика

Центры проведения

США · 1 центр

• Harding Hospital — Columbus

Идентификаторы

NCT: NCT06094218 · 2022H0245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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