Suicidal Ideation, Suicide Attempt
Conditions
Keywords
Suicide, ecological momentary assessment (EMA), Therapeutic Evaluative Conditioning (TEC)
Brief summary
This study aims to evaluate the acceptability, safety, and 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 two-arm randomized controlled trial (RCT) designed to evaluate the safety, acceptability, and 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 60 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, Ma area. Participants will be randomized to receive either the control condition, which consists of 3x/daily ecological momentary assessment (EMA) of emotions and STBs and optional inactive TEC (n = 30), or the experimental condition, consisting of 3x/daily EMA and optional active TEC-S (n = 30). 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 determine if the active TEC-S condition reduces STB and to explore if altered attitudes toward suicide mediates this effect.
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.
BEHAVIORALSmartphone-delivered inactive Therapeutic Evaluative Conditioning
Therapeutic Evaluative Conditioning (inactive TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair positive and negative stimuli (pictures, words) with each other.
Sponsors
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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 |
|---|---|---|
| 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? \[0 (not at all) to 10 (extremely)\]; assessed via 3x/day ecological momentary assessment (Kleiman et al., 2018) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 treatment phase completed (day 1 through 30) | Since the last survey, have you had suicidal thoughts? (yes/no); assessed daily via ecological momentary assessment |
| Suicide planning incidence | Through completion of treatment phase (day 1 through 30) | Since the last survey, have you made a plan to kill yourself? (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 |
| Suicide aversion (AMP) | Through completion of treatment phase (day 1 through 30) | Suicide aversion assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP; Payne et al., 2005) |
| Suicide 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 (Jaroszewski et al., 2022). |
| Self affection (AMP) | Through completion of treatment phase (day 1 through 30) | Self affection assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP; Payne et al., 2005) |
Countries
United States
Contacts
CONTACTAdam C Jaroszewski, PhD
PRINCIPAL_INVESTIGATORAdam C Jaroszewski, PhD
Harvard Medical School, Massachusetts General Hospital
Outcome results
None listed