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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
Sponsor:
Information provided by (Responsible Party):
Kate Aamund, Mental Health Services in the Capital Region, Denmark

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Depressiv symptoms [ Time Frame: 12 month ]
    Depressive symptoms measured by Major depression Inventory, MDI)

  2. Hopelessness [ Time Frame: 12 month ]
    Hopelessness measured by Becks Hopelessness Scale, BHS-21items


Other Outcome Measures:
  1. Quality of life [ Time Frame: 12 month (Baseline, 3 month, ]
    Quality of life measured by WHO-5

  2. Satisfaction [ Time Frame: 12 month ]
    Satisfaction measured by a modified version of CSQ-8



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smart phone (Iphone/android)
  • Understand sufficient Danish to use MYPLAN
  • Informed written consent

Exclusion Criteria:

  • Alcohol or substance abuse disorder (DSM-V)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877316


Contacts
Contact: Kate Aamund, MD, Ph.D. +45 38643024 kate.aamund@regionh.dk
Contact: Annette Erlangsen, Ph.D +45 40263918 annette.erlangsen@regionh.dk

Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Investigators
Study Chair: Merete Nordentoft, MD, Ph.D MSc Mental Health Center Copenhagen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kate Aamund, MD, postdoctoral researcher, Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT02877316     History of Changes
Other Study ID Numbers: MHSCRDenmark
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms