A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

Обзор

This study aims to evaluate the acceptability, safety, and 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 two-arm randomized controlled trial (RCT) designed to evaluate the safety, acceptability, and 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 60 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, Ma area.

Participants will be randomized to receive either the control condition, which consists of 3x/daily ecological momentary assessment (EMA) of emotions and STBs and optional inactive TEC (n = 30), or the experimental condition, consisting of 3x/daily EMA and optional active TEC-S (n = 30). 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 determine if the active TEC-S condition reduces STB and to explore if altered attitudes toward suicide mediates this effect.

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

Первичные конечные точки

• Desire to die by suicide (Likert) [Срок оценки: Through completion of treatment phase (day 1 through 30)]

Вторичные конечные точки (10)

• Suicide intent (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 treatment phase completed (day 1 through 30)]
• Suicide planning 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)]
• Suicide aversion (AMP) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
• Suicide aversion (Likert) [Срок оценки: Through completion of treatment phase (day 1 through 30)]
• Self affection (AMP) [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

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06686901 · 2024P003049-phase2 · K23MH133876

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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