Suicide Attempt, Suicide Ideation
Conditions
Keywords
Suicide, Ecological momentary assessment (EMA), Therapeutic Evaluative Conditioning (TEC)
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).
Interventions
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.
Sponsors
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTAdam C Jaroszewski, PhD
Outcome results
None listed