Background: Individuals with a past episode of self-harm or severe suicidal ideation are at elevated risk of (repeated) self-harm as well as suicide. Suicidal ideation fluctuates over time and is challenging to predict. Having a safety plan will assist people at risk of suicide in using helpful coping strategies and reaching professional assistance if needed. The aim of the trial is to investigate whether a newly developed app-based safety planning tool (MYPLAN), in comparison with a safety plan on paper, is more effective in reducing suicide ideation and other symptoms.
Data and methods: The trial is designed as a two-arm observer-blinded parallel group randomized clinical superiority trial, where participants will either receive: 1) Experimental intervention: the safety plan provided as the app MYPLAN, or 2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, it was initially planned to include a total of 546 participants, 273 in each arm. Participants were be recruited from Danish Suicide Prevention Clinics and other clinical settings. Both groups received standard therapeutic care. The primary outcome was reduction in suicide ideation after 12 months. Follow-up questionnaires were distributed at 3, 6, 9, and 12 months after date of inclusion.
Results: A total of 365 participants were enrolled in the trial, 199 (54.5%) participants were allocated to intervention arm A and 166 (45.5%) participants were allocated to intervention arm B. At 6-month, 213 (58.4 %) participants responded to the follow-up questionnaires, while 183 (50.1%) participants responded at 12-month follow-up. Due to blinding during the analyses, the two arms are currently masked. The results of the analyses will be available at the time of the conference.
Conclusion: A safety plan is an obligatory part of the treatment in the Suicide Prevention Clinics in Demark. Yet, the effectiveness of a safety plan app in reducing suicide ideation has not previously been compared to a safety plan on paper. The trial will generate important insights regarding digital interventions for suicide prevention.