A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

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.

• Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S) (Behavioral): 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.
• Smartphone-delivered inactive Therapeutic Evaluative Conditioning (Behavioral): 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.

Primary outcomes

• 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 outcomes

• 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)

Sex: All, ages: 18 Years to any

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.

• Adam C Jaroszewski, PhD, Principal investigator, Harvard Medical School, Massachusetts General Hospital

NIH grants: K23MH133876