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

April 15, 2026 updated by: Adam C. Jaroszewski, PhD, Massachusetts General Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Desire to die by suicide (Likert)
Time Frame: Through completion of treatment phase (day 1 through 30)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Suicide intent (Likert)
Time Frame: Through completion of treatment phase (day 1 through 30)
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)
Time Frame: Through completion of treatment phase (day 1 through 30)
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
Time Frame: Through treatment phase completed (day 1 through 30)
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
Time Frame: Through completion of treatment phase (day 1 through 30)
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
Time Frame: Through completion of treatment phase (day 1 through 30)
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
Time Frame: Through completion of treatment phase (day 1 through 30)
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)
Time Frame: Through completion of treatment phase (day 1 through 30)
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)
Time Frame: Through completion of treatment phase (day 1 through 30)
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)
Time Frame: Through completion of treatment phase (day 1 through 30)
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)
Time Frame: Through completion of treatment phase (day 1 through 30)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam C Jaroszewski, PhD, Harvard Medical School, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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