Status:
NOT_YET_RECRUITING
A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Suicide Attempt
Suicide Ideation
Eligibility:
All Genders
18+ years
Phase:
NA
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 suicid...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06967545
Start Date
November 1 2025
End Date
August 1 2026
Last Update
September 24 2025
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