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

Massachusetts General Hospital20 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Suicide Attempt Suicide Ideation

Interventions

Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

TEC-S Acceptability

(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.