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Идёт набор NCT06967545

A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

Без фазы С лечением Suicide Attempt Suicide Ideation

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: Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S).
Кому может быть актуально
Состояния в реестре: Suicide Attempt, Suicide Ideation. 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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Обзор

This study aims to evaluate the acceptability, safety, and preliminary efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.

Подробное описание

The present study is a one-arm open trial designed to evaluate the safety, acceptability, and preliminary efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S), a smartphone-delivered intervention aimed at reducing suicidal thoughts and behaviors (STB). Participants in this study will be 20 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, MA area.

Participants will receive 3x/daily EMA and optional access to active TEC-S. Evaluative conditioning uses classical conditioning to alter attitudes. The aim of TEC-S is to alter attitudes toward suicide and, in turn, reduce STB. EMAs will monitor STB, safety, and acceptability, and efficacy. Weekly behavioral and self-report assays will assess hypothesized treatment mechanisms. The study's aim is to evaluate the safety, acceptability, and preliminary efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S).

Вмешательства

  • Поведенческое Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)
    Therapeutic Evaluative Conditioning for Suicide (active TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair suicidal behavior stimuli (pictures, words) with other negative stimuli and self-related stimuli with positive stimuli.

Первичные конечные точки

  • TEC-S Acceptability [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • TEC-S Safety [Срок оценки: Through completion of treatment phase (day 1 through 30)]
Вторичные конечные точки (10)
  • Desire to die by suicide (Likert) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicide urge (Likert) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicide thought incidence [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicide preparation incidence [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicide attempt incidence [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicidal behaviors (composite) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicidal aversion (AMP) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicidal aversion (Likert) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicidal affection (AMP) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
  • Suicide intent (Likert) [Срок оценки: Through completion of treatment phase (day 1 through 30)]

Критерии участия

Критерии включения

  • Adults ages 18+
  • Relatively frequent and recent (≥5 days within the past-month) active suicidal thoughts as assessed via SITBI-R.
  • Willing and able to provide at least one emergency contact (name, phone number, relation).
  • Owns an Android or iOS smartphone.
  • Possesses at least occasional access to Wi-Fi-enabled internet for data down/uploads.
  • Fluent in English and willing to provide informed consent.
  • Living in the Boston metropolitan area (i.e., \~50 mile radius around Boston, MA)

Критерии исключения

  • Recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.2.
  • Recent acute suicide risk operationalized as affirmative responses to BOTH below items during structured clinical interview AND evaluation by the PI in consultation with Mentors/Advisor Drs. Wilhelm, Kleiman, and/or Bentley:
  • At any time in past week: ≥ 8/10 current intent to act on suicidal thoughts (0 \["not at all"\] to 10 \["extremely strong"\]); AND
  • At any time in past week: thought of a specific suicide plan (i.e, known method/means and/or location) with access to lethal means
  • Impaired vision (e.g., legal blindness), technological illiteracy, or intellectual disability that might impair ability to provide valid data and/or informed consent.

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
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06967545 · 2024P003049-phase1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗