MYPLAN - Effectiveness of a Safety Plan App to Manage Crisis of Persons at Risk of Suicide - a Multi-center, Superiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 546
- 试验地点
- 5
- 主要终点
- Suicide ideation
研究概览
简要总结
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.
详细描述
MYPLAN -mobile phone application to manage crisis of persons at risk of suicide:
a multi-center, superiority randomized clinical trial.
Andreasson K, Krogh J, Frandsen H, Buus N, Bech. P Nordentoft M, Erlangsen A Background
In Denmark, there are 8-10,000 people who attempt suicide on a yearly basis1. Suicide ideation is a part of a continuum, where initial suicidal ideation might develop into concrete plans and actions, depending on the suicidal intent suicidal actions might end as suicide attempts or completed suicide2 . Therefore, in order to prevent suicidal behavior and suicides, it is important to avoid or reduce suicide ideation; i.e. securing better control of painful thoughts and the suicidal behavior. This can be done with a safety plan. The safety plan has been developed as a cognitive therapeutic intervention applied empirically in some earlier studies 345. The safety plan can be considered as a part of a cognitive behavior therapeutic intervention, which reduces the suicidal risk and consists of basic components, such as 1) recognizing warning signs of an upcoming suicidal crisis, 2) work with internal coping strategies, 3) distraction from suicidal thoughts, by the use of social contacts and social settings6. This can be done by removing assess of lethal means, and self-monitoring the triggers of the "suicidal mode"7.
To prevent suicidal behavior, The National Board of Health has established Suicide Prevention Clinics nationwide in Denmark. The clinics offering highly specialized short-term supportive psychotherapy and social counselling for suicidal patients in an outpatient setting. The target group is a subsample of all persons with severe suicide ideation or suicide attempts as the clinics focus on persons at risk of suicide who do not have severe underlying psychiatric disorders that required psychiatric admission or specialized treatment8. Some clinics are specialized in children and adolescents and will offer support patients young as 10 years of age. The safety plan is an integral part of the treatment and all patient works with during the first sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smart phone (Iphone/android)
- •Understand sufficient Danish to use MYPLAN
- •Informed written consent
排除标准
- •Alcohol or substance abuse disorder (DSM-V)
结局指标
主要结局
Suicide ideation
时间窗: 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).
次要结局
- Depressiv symptoms(12 month)
- Hopelessness(12 month)
研究者
Kate Aamund
MD, postdoctoral researcher
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital