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

NCT06686901 | Not Yet Recruiting DMC

• 2 other identifiers: 2024P003049-phase2K23MH133876
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Suicidal Ideation; Suicide Attempt

Keywords

Suicide; ecological momentary assessment (EMA); Therapeutic Evaluative Conditioning (TEC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Suicide intent (Likert)

  Through completion of treatment phase (day 1 through 30)

• Suicide urge (Likert)

  Through completion of treatment phase (day 1 through 30)

• Suicide thought incidence

  Through treatment phase completed (day 1 through 30)

• Suicide planning incidence

  Through completion of treatment phase (day 1 through 30)

• Suicide preparation incidence

  Through completion of treatment phase (day 1 through 30)

Study Arms (2)

Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC)

PLACEBO COMPARATOR

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

Behavioral: Smartphone-delivered inactive Therapeutic Evaluative Conditioning

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

EXPERIMENTAL

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)

Interventions

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

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.

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

Smartphone-delivered inactive Therapeutic Evaluative Conditioning BEHAVIORAL

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.

Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Adam C Jaroszewski, PhD

CONTACT

781-258-3082; ajaroszewski@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01