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

Abstract

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.

Figure 1.. Participant Flow

DBT indicates dialectical behavior therapy. ^aTo be enrolled, participants had to have completed the 9-item Patient Health Questionnaire (PHQ-9) at outpatient visits and reported thoughts of death or self-harm on “more than half the days” (PHQ-9 item 9 score of 2) or “nearly every day” (PHQ-9 item 9 score of 3) during the past 2 weeks, and had to have previously used online messaging via the electronic health record patient portal. ^bSee eAppendix 5 in Supplement 2 for details on patients not offered intervention services. ^cRandomization occurred up to 8 days following an eligible visit, and some patients died or disenrolled from the health system prior to randomization but before records of death or disenrollment were available. See eAppendix 4 in Supplement 2 for details.

Figure 2.. Time to First Instance of Fatal or Nonfatal Self-harm by Initial Randomization Group

Fatal self-harm was ascertained by linkage to state mortality data. Nonfatal self-harm was ascertained from health system electronic health record and insurance claims data, including injuries and poisonings diagnosed as self-harm and injuries and poisonings receiving selected other diagnoses but confirmed as self-harm by review of full-text medical records (eAppendix 6 in Supplement 2). The hazard ratio for care management vs usual care is 1.07 (97.5% CI, 0.84-1.37), and the hazard ratio for skills training vs usual care is 1.29 (97.5% CI, 1.02-1.64).

Figure 3.. Use of Specific Health Services Over 12 Months Following Randomization

The panels show adjusted mean number of visits or admissions per month, with error bars indicating 97.5% CIs, according to initial randomization. Monthly utilization was modeled as a function of time using generalized estimating equations. Twelve-month utilization was calculated by summing coefficient estimates; the Delta method was used to calculate standard errors. A t statistic was used to compare 12-month utilization in each of the intervention groups with usual care. Mean visits/admissions per person over 12 months were as follows: for mental health specialty outpatient visits (panel A), 7.50 (97.5% CI, 7.05-7.96; P = .63 vs usual care) for care management, 7.65 (97.5% CI, 7.65-8.1; P = .88 vs usual care) for skills training, and 7.62 (97.5% CI, 7.15-8.08) for usual care; for primary care outpatient visits with mental health diagnoses (panel B), 1.35 (97.5% CI, 1.23-1.46; P = .22 vs usual care) for care management, 1.41 (97.5% CI, 1.29-1.52; P = .65 vs usual care) for skills training, and 1.44 (97.5% CI, 1.31-1.57) for usual care; for emergency department visits with mental health diagnoses (panel C), 0.31 (97.5% CI, 0.27-0.35; P = .15 vs usual care) for care management, 0.33 (97.5% CI, 0.28-0.39; P = .02 vs usual care) for skills training; and 0.28 (97.5% CI, 0.24-0.32) for usual care; and for inpatient admissions with mental health diagnoses (panel D), 0.19 (97.5% CI, 0.16-0.21; P = .09 vs usual care) for care management, 0.19 (97.5% CI, 0.16-0.21; P = .05 vs usual care) for skills training, and 0.17 (97.5% CI, 0.14-0.19) for usual care.