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

NCT ID: NCT06967545

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The present study is a one-arm open trial designed to evaluate the safety, acceptability, and preliminary 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 20 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, MA area.

Participants will receive 3x/daily EMA and optional access to active TEC-S. 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 evaluate the safety, acceptability, and preliminary efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicide Attempt Suicide Ideation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam C. Jaroszewski, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Adam C Jaroszewski, PhD

Role: CONTACT

781-258-3082

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adam Jaroszewski, Ph.D.

Role: primary

617 ext. 617.724.9149

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024P003049-phase1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treating Suicidality Remotely
NCT06370104 RECRUITING NA
Therapy and Tech Study
NCT07225192 NOT_YET_RECRUITING NA