Clinical trial NCT06686901: A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
Official title: A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide Attempt
Keywords: Suicide
ecological momentary assessment (EMA)
Therapeutic Evaluative Conditioning (TEC)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Desire to die by suicide (Likert)
timeFrame: Through completion of treatment phase (day 1 through 30)
Secondary outcomes:
measure: Suicide intent (Likert)
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicide urge (Likert)
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicide thought incidence
timeFrame: Through treatment phase completed (day 1 through 30)
measure: Suicide planning incidence
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicide preparation incidence
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicide attempt incidence
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicidal behaviors (composite)
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicide aversion (AMP)
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Suicide aversion (Likert)
timeFrame: Through completion of treatment phase (day 1 through 30)
measure: Self affection (AMP)
timeFrame: Through completion of treatment phase (day 1 through 30)
Other outcomes:
Locations:
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