Suicide Prevention Clinical Trial
— MYPLANOfficial title:
MYPLAN - Effectiveness of a Safety Plan App to Manage Crisis of Persons at Risk of Suicide - a Multi-center, Superiority Randomized Clinical Trial
NCT number | NCT02877316 |
Other study ID # | MHSCRDenmark |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | November 2022 |
Verified date | October 2023 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 546 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Smart phone (Iphone/android) - Understand sufficient Danish to use MYPLAN - Informed written consent Exclusion Criteria: - Alcohol or substance abuse disorder (DSM-V) |
Country | Name | City | State |
---|---|---|---|
Denmark | Psychiatric centre Ballerup, Clinic for psychoterapy | Ballerup | |
Denmark | Competence centre for suicide prevention | Copenhagen | |
Denmark | Psychiatric Centre North Zealand | Hillerød | |
Denmark | Clinic for suicide prevention | Køge |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark |
Denmark,
Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563. — View Citation
Christiansen E, Jensen BF. Register for Suicide Attempts. Dan Med Bull. 2004 Nov;51(4):415-7. — View Citation
Erlangsen A, Lind BD, Stuart EA, Qin P, Stenager E, Larsen KJ, Wang AG, Hvid M, Nielsen AC, Pedersen CM, Winslov JH, Langhoff C, Muhlmann C, Nordentoft M. Short-term and long-term effects of psychosocial therapy for people after deliberate self-harm: a register-based, nationwide multicentre study using propensity score matching. Lancet Psychiatry. 2015 Jan;2(1):49-58. doi: 10.1016/S2215-0366(14)00083-2. Epub 2015 Jan 8. — View Citation
Stanley B, Brown G, Brent DA, Wells K, Poling K, Curry J, Kennard BD, Wagner A, Cwik MF, Klomek AB, Goldstein T, Vitiello B, Barnett S, Daniel S, Hughes J. Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. J Am Acad Child Adolesc Psychiatry. 2009 Oct;48(10):1005-1013. doi: 10.1097/CHI.0b013e3181b5dbfe. — View Citation
Yanos PT, Stanley BS, Greene CS. Research risk for persons with psychiatric disorders: a decisional framework to meet the ethical challenge. Psychiatr Serv. 2009 Mar;60(3):374-83. doi: 10.1176/ps.2009.60.3.374. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life index | Quality of life measured by WHO-5 | 12 month (Baseline, 3 month, | |
Other | Satisfaction of the app | Satisfaction measured by a modified version of CSQ-8 | 12 month | |
Primary | Suicide ideation | 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). | 12 month | |
Secondary | Depressiv symptoms | Depressive symptoms measured by Major depression Inventory, MDI) | 12 month | |
Secondary | Hopelessness | Hopelessness measured by Becks Hopelessness Scale, BHS-21items | 12 month |
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