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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Suicide Attempt
• Intervention / Treatment: Behavioral: Smartphone-delivered inactive Therapeutic Evaluative Conditioning; Behavioral: Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam C Jaroszewski, PhD; Phone Number: 781-258-3082; Email: ajaroszewski@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Adam Jaroszewski, PhD; Phone Number: 781-258-3082; Email: ajaroszewski@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC); Optional smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) for 30 days.	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.
Experimental: Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC); Optional smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC-S) for 30 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desire to die by suicide (Likert)	Right now, how strongly do you want to kill yourself? [0 (not at all) to 10 (extremely)]; assessed via 3x/day ecological momentary assessment (Kleiman et al., 2018)	Through completion of treatment phase (day 1 through 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide intent (Likert)	Right now, how strong is your intention to kill yourself today? [0 (I am definitely not going to kill myself today) to 10 (I am definitely going to kill myself today)]; assessed via 3x/day ecological momentary assessment	Through completion of treatment phase (day 1 through 30)
Suicide urge (Likert)	Right now, how strong is your urge to kill yourself [0 (not at all) to 10 (very strong)]; assessed via 3x/day ecological momentary assessment.	Through completion of treatment phase (day 1 through 30)
Suicide thought incidence	Since the last survey, have you had suicidal thoughts? (yes/no); assessed daily via ecological momentary assessment	Through treatment phase completed (day 1 through 30)
Suicide planning incidence	Since the last survey, have you made a plan to kill yourself? (yes/no); assessed daily via ecological momentary assessment	Through completion of treatment phase (day 1 through 30)
Suicide preparation incidence	Since the last survey, have you made any preparations to kill yourself? (yes/no); assessed daily via ecological momentary assessment.	Through completion of treatment phase (day 1 through 30)
Suicide attempt incidence	Since the last survey, have you attempted to kill yourself? (yes/no); assessed daily via ecological momentary assessment	Through completion of treatment phase (day 1 through 30)
Suicidal behaviors (composite)	A composite variable consisting of (i) suicide plan incidence, (ii) suicide preparation incidence, (iii) suicide attempt incidence, each assessed via ecological momentary assessment	Through completion of treatment phase (day 1 through 30)
Suicide aversion (AMP)	Suicide aversion assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP; Payne et al., 2005)	Through completion of treatment phase (day 1 through 30)
Suicide aversion (Likert)	Valence ratings of suicide-related pictures using a 9-point scale (-4 [extremely unpleasant] to 0 [neutral] to 4 [extremely pleasant]); assessed weekly (Jaroszewski et al., 2022).	Through completion of treatment phase (day 1 through 30)
Self affection (AMP)	Self affection assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP; Payne et al., 2005)	Through completion of treatment phase (day 1 through 30)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Adam C Jaroszewski, PhD, Harvard Medical School, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Suicide; ecological momentary assessment (EMA); Therapeutic Evaluative Conditioning (TEC)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 2024P003049-phase2; K23MH133876 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No