A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- TEC-S Acceptability
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.
- •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.
研究组 & 干预措施
Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC)
Optional smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC-S) for 30 days.
干预措施: Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S) (Behavioral)
结局指标
主要结局
TEC-S Acceptability
时间窗: Through completion of treatment phase (day 1 through 30)
(i) Indexed as the proportion of TEC-S sessions accessed within the first week, (ii) adapted items from the Credibility/Expectancy Questionnaire (CEQ), rated on a 9-point scale. : "How satisfied were you with your overall experience with TEC-S?" "How satisfied were you with your understanding of how to complete TEC-S (iii)End-User Mobile Application Rating Scale (uMARS), with items rated on a 5-point scale.
TEC-S Safety
时间窗: Through completion of treatment phase (day 1 through 30)
Changes in suicide-related thoughts (e.g., intent, desire, urge, preparation) and affective responses (e.g. stress) before and after randomized stimuli in each TEC-S session, assessed via ecological momentary assessment
次要结局
- Desire to die by suicide (Likert)(Through completion of treatment phase (day 1 through 30))
- Suicide urge (Likert)(Through completion of treatment phase (day 1 through 30))
- Suicide thought incidence(Through completion of treatment phase (day 1 through 30))
- Suicide preparation incidence(Through completion of treatment phase (day 1 through 30))
- Suicide attempt incidence(Through completion of treatment phase (day 1 through 30))
- Suicidal behaviors (composite)(Through completion of treatment phase (day 1 through 30))
- Suicidal aversion (AMP)(Through completion of treatment phase (day 1 through 30))
- Suicidal aversion (Likert)(Through completion of treatment phase (day 1 through 30))
- Suicidal affection (AMP)(Through completion of treatment phase (day 1 through 30))
- Suicide intent (Likert)(Through completion of treatment phase (day 1 through 30))
研究者
Adam C. Jaroszewski, PhD
Principal Investigator
Massachusetts General Hospital