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Not yet recruiting Not applicable NCT06686901

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

No applicable phase (e.g. observational)
Conditions: Suicidal Ideation Suicide Attempt

Sponsor: Massachusetts General Hospital

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Interventions
Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)
BEHAVIORAL
Smartphone-delivered inactive Therapeutic Evaluative Conditioning
BEHAVIORAL
Locations 1
United States (1)
Massachusetts General Hospital
Boston , Massachusetts
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2027
Completion date
31.08.2029
Registry ID
NCT06686901
Source
clinicaltrials.gov
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