Trial Outcomes & Findings for Drivers of Suicide Mobile App Study (NCT NCT05427734)

Participants were recruited through primary care clinics and a third-party organization, User Interviews.

401 individuals completed the initial screen. Of the 176 eligible, 45 were lost to follow-up, and 4 declined to participate before completing the informed consent. 127 participants completed consent and were randomized to a condition.

Based on feedback from the FDA, participants aged 22 and older were eligible to participate in this study.

A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Peak Suicidal Ideation Intensity, Suicide Plan Forecasting, and Suicide Attempt Forecasting are scored on a 5-point scale (0=Low/Little; 4=Very much/Severe). Higher scores indicate higher intensity of suicidal ideation and greater likelihood to make a suicide plan and attempt.

A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Past 30-Day Suicidal Ideation Frequency refers to the number of times in the past month the behavior occurred. A higher number indicates a greater number of suicidal thoughts experienced in the last month.

17-item, with 5 items scored in reverse, psychometrically-sound self-report measure of coping with suicidal thoughts, urges, and crises that uses a 5-point rating scale (0=strongly disagree; 4=strongly agree). There are two subscales, internal coping (minimum of 0 and maximum of 28) and external coping (minimum of 0 and maximum of 28). Subscale items are summed to generate total scores for each. Higher subscale scores indicate higher ability to cope with suicidality.

A well-validated, normed set of measures with standardized scoring. The measures of alcohol use (minimum of 0 and maximum of 28) and negative consequences related to alcohol use (minimum of 0 and maximum of 28) have 7 items. The measure of self-efficacy to manage emotions (minimum of 0 and maximum of 16) has 4 items. All measures are scored on a 5-point scale, (i.e., 0=never and 4=almost always for the alcohol use and negative consequences related to alcohol use measures; 0=I am not at all confident and 4=I am very confident for the self-efficacy to manage emotions measure), and responses are summed to create a raw total score for each measure. Higher scores for each measure indicate greater alcohol use, negative consequences related to alcohol use, and higher self-efficacy to manage emotions.

An eight-item survey used in EBPI's earlier research, which focuses on an app's ease of use and helpfulness. The initial six items use a five-point rating scale (1=poor; 5=excellent). Users also provide an overall satisfaction rating for their condition app using a 100-point scale (1=the worst; 100=the best) and indicate whether they would recommend using the app to others in their situation. The scores for the initial six items were also summed and averaged to generate the Average of Satisfaction Items score. Higher scores indicate the app has greater ease of use and helpfulness, and the respondent felt more cared about, supported, likely to recommend the app, and greater satisfaction with the app.

A 10-item psychometrically sound self-report measure (minimum 0 and maximum 40) used to assess alcohol intake, potential dependence on alcohol, and experience of alcohol-related harm. Items 1-8 are scored on a 5-point scale (0=Never to 4=Daily or almost daily; 0=Never to 4=4 or more times a week; 0=1 or 2 to 4=10 or more). Items 9 and 10 are scored on a 3-point scale (0=No; 2=Yes, but not in the last year; 4=Yes, during the last year). Items are summed to generate a total score. A score of 0 suggests no experience with problems related to alcohol use; 1 to 7 suggests low-risk consumption; 8 to 14 suggest hazardous or harmful alcohol consumption; and 15 or more indicates the likelihood of alcohol dependence.

A 10-item psychometrically validated self-administered screening tool (minimum of 0 and maximum of 10) for drug-related problems. Items are scored on a binary scale. (No=0; Yes=1), except for item 3 which is reverse scored. Items are summed to generate a total score. Higher scores indicate a greater degree of problems related to drug use.

The nine-item questionnaire assesses recent depressive symptoms, and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. Scores of 1-9 indicate minimal to mild depression; 10-14, moderate depression; and 15-19, moderate to severe depression.