A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
- Conditions
- Suicide AttemptSuicide Ideation
- Registration Number
- NCT06967545
- Lead Sponsor
- Massachusetts General Hospital
- 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 suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method TEC-S Acceptability 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.
TEC-S Safety 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 Outcome Measures
Name Time Method Suicidal aversion (AMP) Through completion of treatment phase (day 1 through 30) Suicide aversion assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP)
Suicidal aversion (Likert) 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.
Suicidal affection (AMP) Through completion of treatment phase (day 1 through 30) Self affection assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP)
Suicide intent (Likert) 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
Desire to die by suicide (Likert) 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)
Suicide urge (Likert) 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.
Suicide thought incidence 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
Suicide preparation incidence 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.
Suicide attempt incidence 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
Suicidal behaviors (composite) 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