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

Mass General Brigham

Status

Not yet enrolling

Conditions

Suicide Attempt

Suicide Ideation

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06967545

2024P003049-phase1

Details and patient eligibility

About

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.

Full description

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).

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.