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

Mass General Brigham

Status: Begins enrollment in a year or more

Conditions: Suicide Attempt; Suicidal Ideation

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06686901

K23MH133876 (U.S. NIH Grant/Contract)

2024P003049-phase2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC)

Placebo Comparator group

Description:

Optional smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) for 30 days.

Treatment:

Behavioral: Smartphone-delivered inactive Therapeutic Evaluative Conditioning

Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC)

Experimental group

Description:

Optional smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC-S) for 30 days.

Treatment:

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