A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

NCT06967545 | Recruiting DMC

• 1 other identifier: 2024P003049-phase1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the acceptability, safety, and preliminary 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

Suicide Attempt; Suicide Ideation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• TEC-S Acceptability

  (i) Indexed as the proportion of TEC-S sessions accessed within the first week, (ii) adapted items from the Credibility/Expectancy Questionnaire (CEQ), rated on a 9-point scale. : "How satisfied were you with your overall experience with TEC-S?" "How satisfied were you with your understanding of how to complete TEC-S (iii)End-User Mobile Application Rating Scale (uMARS), with items rated on a 5-point scale.

  Through completion of treatment phase (day 1 through 30)

• TEC-S Safety

  Changes in suicide-related thoughts (e.g., intent, desire, urge, preparation) and affective responses (e.g. stress) before and after randomized stimuli in each TEC-S session, assessed via ecological momentary assessment

  Through completion of treatment phase (day 1 through 30)

Secondary Outcomes (10)

• Desire to die by suicide (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 completion of treatment phase (day 1 through 30)

• Suicide preparation incidence

  Through completion of treatment phase (day 1 through 30)

• Suicide attempt incidence

  Through completion of treatment phase (day 1 through 30)

Study Arms (1)

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)

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)