“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”, 2022-02-15 (; similar):
Question: Can low-intensity outreach programs, based on effective clinical interventions but delivered primarily online, prevent self-harm or suicidal behavior among outpatients reporting frequent suicidal ideation?
Results: In this pragmatic randomized clinical trial that included 18,882 outpatients with frequent suicidal ideation, the percentage with nonfatal or fatal self-harm over 18 months was 3.3% among those offered care management, 3.9% among those offered online dialectical behavior therapy skills training, and 3.1% among those receiving usual care, respectively. Compared with usual care, the risk of self-harm was not statistically-significantly different for care management but was statistically-significantly increased for those offered skills training.
Meaning: Compared with usual care, offering care management did not statistically-significantly reduce the risk of self-harm, and offering brief online dialectical behavior therapy skills training increased the risk of self-harm among at-risk adults.
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, & 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 = 2,020) that included systematic outreach and care, a skills training intervention (n = 2,020) that introduced 4 dialectical behavior therapy skills (mindfulness, mindfulness of current emotion, opposite action, and paced breathing), or usual care (n = 2,020). 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 & 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 (2,020 [48%] aged 45 years or older; 12,543 [67%] female; 2,020 [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. 31% 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 statistically-significantly between the care management and usual care groups (hazard ratio [HR], 1.07; 97.5% CI, 0.84–1.37) but was statistically-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 & Relevance: Among adult outpatients with frequent suicidal ideation, offering care management did not statistically-significantly reduce risk of self-harm, and offering brief dialectical behavior therapy skills training statistically-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.