Background: Persons with a past episode of self-harm or severe suicidal ideation are at
elevated risk of self-harm as well as dying by suicide. It is well established that suicidal
ideation fluctuates over time. Safety plans in paper format are mandatory part of the
treatment regime in the suicide preventive clinics in Denmark. The aim of the trial is to
compare the paper version of the safety plan with a new-developed app in reducing suicide
ideation and other symptoms, as an add-on to the supportive psychotherapy delivered in the
Hypothesis: It is hypothesized that participants randomized to MYPLAN will have lower suicide
ideation as well as improvements on the secondary outcomes than users who have the paper
Methods: The trial is designed as a 2-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. Both intervention groups will also receive standard psychosocial
therapeutic care, up to 8-10 sessions of supportive psychotherapy.Based on a power
calculation a total of 546 participants, 273 in each arm will be included. They will be
recruited from national suicide preventive clinics. Follow-ups will be conducted at 3, 6, 9,
and 12 months after date of inclusion.
Participants, inclusion and exclusion criteria: There is no age restriction on participation
in the study and all participants will be recruited from the suicide prevention clinics in
Denmark. These clinics are highly specialized outpatient care centers, offering short-term
supportive psychotherapy and social counselling for suicidal patients. In order to
participate in the study, participants must have a smartphone (IPhone or android phone) and
understand sufficient Danish to use MYPLAN. Persons having a particularly severe alcohol or
substance abuse disorder, which might inflict with skills of orientation and memorywill not
be offered participation in the RCT.
Outcomes Patient reported outcomes (PROM) are collected at baseline and follow-up through
self-administered tablet/internet-based questionnaires. Primary outcome is suicide ideation.
Secondary outcomes are:, hopelessness, depressive symptoms, quality of life, and modified
Statistical analysis: Data analysis will be based on intention-to-treat principle. We will
examine this using repeated measurement in mixed models. Missing data will be handled with
The trial will start in November 2016 and patient recruitment is expected to finish November
2017. Analysis and results are expected in 2018.