Offering care management to adult outpatients experiencing suicidal ideation did not reduce their risk of self-harm compared to usual care. Patients offered dialectical behavior therapy (DBT) skills training had significantly greater risk of self-harm compared to usual care.
These were the main findings of the Suicide Prevention Outreach Trial (SPOT), an NIH Pragmatic Trials Collaboratory Trial.
The report was published this month in JAMA.
SPOT, a pragmatic randomized clinical trial embedded in 4 healthcare systems, compared 2 low-intensity outreach programs—care management and DBT skills training—to usual care in adults at risk of self-harm or suicidal behavior.
More than 18,000 patients participated in the study from March 2015 to March 2020. Adult outpatients who reported suicidal ideation on a mental health questionnaire were randomly assigned to 1 of 3 study groups: continued usual care, offer of a care management intervention program, and offer of a DBT skills training program.
“The inclusion of a usual care group was an important aspect of our study,” said Dr. Gregory Simon of Kaiser Permanente Washington Health Research Institute, SPOT’s principal investigator. “This control group allowed us to not only compare the effectiveness of one intervention to another, but also allowed us to determine the value of implementing either intervention.”
Patients in the care management intervention group received regular screening for suicide risk followed by guideline-based care appropriate to the patient’s assessed risk level for up to 12 months after enrollment. Care managers reported the patients’ risk level to outpatient clinicians who made decisions regarding further treatment. The care management intervention was intended to facilitate and maintain engagement in effective outpatient care.
Patients in the DBT skills training group received online video instruction on 4 specific DBT skills: mindfulness, mindfulness of current emotion, opposite action, and paced breathing. Skills coaches sent digital messages encouraging continued practice of the DBT skills for up to 12 months after enrollment.
Researchers followed participant outcomes for 18 months after enrollment. The percentage of fatal or nonfatal self-harm events was 3.1% for those receiving usual care, 3.3% for those offered care management, and 3.9% for patients offered DBT skills training.
Additional analysis of patient subgroups found that the risk of self-harm varied with patients’ level of intervention participation. In both intervention groups, patients who actively declined intervention services had the lowest risk of self-harm. Patients who did not respond to the invitation to participate or who actively participated for more than 3 months had intermediate risk. Patients who initially participated in the intervention but continued for less than 3 months had the highest risk.
“A patient’s willingness to engage in an intervention can have a significant impact on its effectiveness,” Dr. Simon said. “When you attempt to deliver an intervention with no real-time feedback, there’s no way to know how that message is being received by the patient. A study team should not continue to reach out to a patient who finds it unhelpful. We believe that real-time feedback is essential to ensure patients are engaged so that the intervention can be implemented effectively,” said Dr. Simon.
SPOT was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.
Watch Dr. Simon and colleague Dr. Susan Shortreed discuss the outcomes of SPOT in this NIH Pragmatic Trials Collaboratory PCT Grand Rounds presentation.