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NCT Number: NCT06967545

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

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.

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Key information

Conditions

Suicide Attempt Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide Ideation Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Adam Jaroszewski, Ph.D.

CONTACT

[email protected]

617-724-9149

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. TEC-S Acceptability

    Time frame: Through completion of treatment phase (day 1 through 30)

    (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.

  2. TEC-S Safety

    Time frame: Through completion of treatment phase (day 1 through 30)

    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

Secondary outcomes

  1. 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)

  2. 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.

  3. Suicide thought incidence

    Time frame: Through completion of treatment phase (day 1 through 30)

    Since the last survey, have you had suicidal thoughts? (yes/no); assessed daily via ecological momentary assessment

  4. 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.

  5. 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

  6. 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

  7. Suicidal aversion (AMP)

    Time frame: Through completion of treatment phase (day 1 through 30)

    Suicide aversion assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP)

  8. Suicidal 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.

  9. Suicidal affection (AMP)

    Time frame: Through completion of treatment phase (day 1 through 30)

    Self affection assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP)

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Adam C Jaroszewski, PhD

CONTACT

[email protected]

781-258-3082

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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