MYPLAN - Effectiveness of a Safety Plan App to Manage Crisis of Persons at Risk of Suicide (MYPLAN)
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|ClinicalTrials.gov Identifier: NCT02877316|
Recruitment Status : Not yet recruiting
First Posted : August 24, 2016
Last Update Posted : August 25, 2016
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 clinics.
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 version.
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 CSQ-8.
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 multiple imputations.
The trial will start in November 2016 and patient recruitment is expected to finish November 2017. Analysis and results are expected in 2018.
|Condition or disease||Intervention/treatment||Phase|
|Suicide Prevention Suicidal Thoughts Suicide Attempts||Other: MYPLAN-safety plan as an application for smart phones Other: safety plan on paper||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||546 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||MYPLAN - Effectiveness of a Safety Plan App to Manage Crisis of Persons at Risk of Suicide - a Multi-center, Superiority Randomized Clinical Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: MYPLAN app
MYPLAN app (safety plan) as part of treatment
Other: MYPLAN-safety plan as an application for smart phones
MYPLAN app as a integral part of the standard treatment
Active Comparator: Safety plan on paper
Safety plan on paper as part of treatment
Other: safety plan on paper
Standard treatment with safety plan on paper
- Suicide ideation [ Time Frame: 12 month ]Primary outcome will be measured as the difference in suicide ideation before entering the trial and after 6 month participation in the trial. This is measured by Becks suicide ideation scale (BSS 21-items).
- Depressiv symptoms [ Time Frame: 12 month ]Depressive symptoms measured by Major depression Inventory, MDI)
- Hopelessness [ Time Frame: 12 month ]Hopelessness measured by Becks Hopelessness Scale, BHS-21items
- Quality of life [ Time Frame: 12 month (Baseline, 3 month, ]Quality of life measured by WHO-5
- Satisfaction [ Time Frame: 12 month ]Satisfaction measured by a modified version of CSQ-8
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877316
|Contact: Kate Aamund, MD, Ph.D.||+45 email@example.com|
|Contact: Annette Erlangsen, Ph.D||+45 firstname.lastname@example.org|
|Study Chair:||Merete Nordentoft, MD, Ph.D MSc||Mental Health Center Copenhagen|