A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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 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).