A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Desire to die by suicide (Likert)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 inactive Therapeutic Evaluative Conditioning (inactive TEC)
Optional smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) for 30 days.
干预措施: Smartphone-delivered inactive Therapeutic Evaluative Conditioning (Behavioral)
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
Desire to die by suicide (Likert)
时间窗: Through completion of treatment phase (day 1 through 30)
Right now, how strongly do you want to kill yourself? \[0 (not at all) to 10 (extremely)\]; assessed via 3x/day ecological momentary assessment (Kleiman et al., 2018)
次要结局
- Suicide intent (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 treatment phase completed (day 1 through 30))
- Suicide planning 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))
- Suicide aversion (AMP)(Through completion of treatment phase (day 1 through 30))
- Suicide aversion (Likert)(Through completion of treatment phase (day 1 through 30))
- Self affection (AMP)(Through completion of treatment phase (day 1 through 30))
- Suicide intent (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 treatment phase completed (day 1 through 30))
- Suicide planning 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))
- Suicide aversion (AMP)(Through completion of treatment phase (day 1 through 30))
- Suicide aversion (Likert)(Through completion of treatment phase (day 1 through 30))
- Self affection (AMP)(Through completion of treatment phase (day 1 through 30))
研究者
Adam C. Jaroszewski, PhD
Principal Investigator
Massachusetts General Hospital