A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S), Smartphone-delivered inactive Therapeutic Evaluative Conditioning.
- Who it may be relevant to
- Registry conditions: Suicidal Ideation, Suicide Attempt. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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.
Interventions
- Behavioral Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)
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. - Behavioral Smartphone-delivered inactive Therapeutic Evaluative Conditioning
Therapeutic Evaluative Conditioning (inactive TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair positive and negative stimuli (pictures, words) with each other.
Primary outcome measures
- Desire to die by suicide (Likert) [Time frame: Through completion of treatment phase (day 1 through 30)]
Secondary outcome measures (10)
- Suicide intent (Likert) [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicide urge (Likert) [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicide thought incidence [Time frame: Through treatment phase completed (day 1 through 30)]
- Suicide planning incidence [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicide preparation incidence [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicide attempt incidence [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicidal behaviors (composite) [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicide aversion (AMP) [Time frame: Through completion of treatment phase (day 1 through 30)]
- Suicide aversion (Likert) [Time frame: Through completion of treatment phase (day 1 through 30)]
- Self affection (AMP) [Time frame: Through completion of treatment phase (day 1 through 30)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06686901 · 2024P003049-phase2 · K23MH133876