Effect of Offering Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adult Outpatients With Suicidal Ideation: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 327; no. 7; pp. 630 - 638
• Main Authors: Simon, Gregory E, Shortreed, Susan M, Rossom, Rebecca C, Beck, Arne, Clarke, Gregory N, Whiteside, Ursula, Richards, Julie E, Penfold, Robert B, Boggs, Jennifer M, Smith, Julia
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 15-02-2022
• Subjects: Adult; Aged; Behavior modification; Behavior therapy; Clinical trials; Dialectical Behavior Therapy; Electronic health records; Electronic medical records; Facilities and Services Utilization - statistics & numerical data; Female; Health care; Health Services - statistics & numerical data; Humans; Intervention; Male; Medical screening; Mental health; Middle Aged; Mindfulness; Original Investigation; Outreach programs; Patient Care - methods; Patients; Prevention; Primary care; Randomization; Risk management; Risk reduction; Self destructive behavior; Self-Injurious Behavior - epidemiology; Self-Injurious Behavior - prevention & control; Self-injury; Skill development; Skills; Suicidal Ideation; Suicide - statistics & numerical data; Suicide Prevention; Suicides & suicide attempts; Therapy; Training
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2022.0423

IMPORTANCE: People at risk of self-harm or suicidal behavior can be accurately identified, but effective prevention will require effective scalable interventions. OBJECTIVE: To compare 2 low-intensity outreach programs with usual care for prevention of suicidal behavior among outpatients who report recent frequent suicidal thoughts. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic randomized clinical trial including outpatients reporting frequent suicidal thoughts identified using routine Patient Health Questionnaire depression screening at 4 US integrated health systems. A total of 18 882 patients were randomized between March 2015 and September 2018, and ascertainment of outcomes continued through March 2020. INTERVENTIONS: Patients were randomized to a care management intervention (n = 6230) that included systematic outreach and care, a skills training intervention (n = 6227) that introduced 4 dialectical behavior therapy skills (mindfulness, mindfulness of current emotion, opposite action, and paced breathing), or usual care (n = 6187). Interventions, lasting up to 12 months, were delivered primarily through electronic health record online messaging and were intended to supplement ongoing mental health care. MAIN OUTCOMES AND MEASURES: The primary outcome was time to first nonfatal or fatal self-harm. Nonfatal self-harm was ascertained from health system records, and fatal self-harm was ascertained from state mortality data. Secondary outcomes included more severe self-harm (leading to death or hospitalization) and a broader definition of self-harm (selected injuries and poisonings not originally coded as self-harm). RESULTS: A total of 18 644 patients (9009 [48%] aged 45 years or older; 12 543 [67%] female; 9222 [50%] from mental health specialty clinics and the remainder from primary care) contributed at least 1 day of follow-up data and were included in analyses. Thirty-one percent of participants offered care management and 39% offered skills training actively engaged in intervention programs. A total of 540 participants had a self-harm event (including 45 deaths attributed to self-harm and 495 nonfatal self-harm events) over 18 months following randomization: 172 (3.27%) in care management, 206 (3.92%) in skills training, and 162 (3.27%) in usual care. Risk of fatal or nonfatal self-harm over 18 months did not differ significantly between the care management and usual care groups (hazard ratio [HR], 1.07; 97.5% CI, 0.84-1.37) but was significantly higher in the skills training group than in usual care (HR, 1.29; 97.5% CI, 1.02-1.64). For severe self-harm, care management vs usual care had an HR of 1.03 (97.5% CI, 0.71-1.51); skills training vs usual care had an HR of 1.34 (97.5% CI, 0.94-1.91). For the broader self-harm definition, care management vs usual care had an HR of 1.10 (97.5% CI, 0.92-1.33); skills training vs usual care had an HR of 1.17 (97.5% CI, 0.97-1.41). CONCLUSIONS AND RELEVANCE: Among adult outpatients with frequent suicidal ideation, offering care management did not significantly reduce risk of self-harm, and offering brief dialectical behavior therapy skills training significantly increased risk of self-harm, compared with usual care. These findings do not support implementation of the programs tested in this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02326883