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临床试验/NCT03825354
NCT03825354已完成不适用

Brief Intervention and Contact (BIC) Program to Manage Suicidal Behaviour: A Pilot Study

St. Joseph's Healthcare Hamilton2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Retention rate

研究概览

简要总结

Suicide is a significant public health concern and causes approximately 1.5 % of all deaths in the general population in Canada. Suicide is a multi-faceted issue that is often comorbid with psychiatric illness and associated with diverse sociodemographic risk factors. Consequently, there are several domains of suicide risk management. The proposed intervention, the brief intervention, and contact (BIC) model will be tested for feasibility using a pilot pragmatic randomized trial.

详细描述

Brief contact interventions are distinct from other treatments for suicide and suicidal behaviour, in that the goals include maintaining long-term contact with patients, and through this, provide opportunities for them to re-engage with mental health services when needed. Additionally, brief interventions are not required to be carried out by mental health professionals (i.e. psychiatrists, psychologists, social workers), and they are provided over a structured schedule over a prolonged period post discharge.

The brief intervention and contact (BIC) model followed in this study is based on the BIC model that was utilised by the WHO as part of the Multisite Intervention Study On Suicidal Behaviours (SUPRE-MISS). A sub-project of the SUPRE-MISS study involved the implementation of a brief intervention that included an hour-long information session about suicide and suicidal behaviour around the discharge period, and nine periods of follow up through an in-person visit or phone call to assess the patient's well-being and provide referrals to clinical services as needed. Following implementation, an analysis of the effectiveness of the BIC model in five different countries, Brazil, India, Sri Lanka, Islamic Republic of Iran, and China, outline its potential utility. Compared to patients in the control group, there was a reduction in suicide rates in patients who received the BIC intervention.

This is a pilot study to test the feasibility of implementing the BIC protocol in a large multisite trial. We will, however, provide the objective of the main study to provide an overview of the study and the intended outcomes in addition to the pilot study objectives as below.

Study question and hypothesis of the main study:

For patients with suicidal behaviour admitted to inpatient units of acute and tertiary hospitals, does the addition of a brief intervention and contact program decrease suicide re-attempts, reduce depressive symptoms, improve social connectivity, and reduce further ER visits, compared to treatment as usual after 18 months of follow-up? The pilot study will be for 6 months only. We hypothesize that brief intervention and contact is an effective intervention for reducing suicidal behaviour in patients who have attempted suicide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with a previous suicide attempt or expressed any suicidal behaviour who are admitted to inpatient psychiatric wards will be asked to participate in this study, with no upper age limit, sex or gender restriction.
  • No restrictions will be placed on the patients' diagnoses or comorbidities, although all diagnoses will be documented.
  • Patients in inpatient units and receiving treatment for comorbid psychiatric illnesses and/or their suicidal behaviour as per usual care including medication, individual or group psychotherapies and other treatment modalities are eligible to participate in the study.
  • All participants must be able to provide written informed consent and can be reached through phone calls and/or text messages or in-person visits to the hospital site.

排除标准

  • We will exclude patients who are unable to understand written and spoken English, as the research staff/clinicians delivering the intervention are limited to English-speaking populations.

结局指标

主要结局

Retention rate

时间窗: 6 months

The percentage of participants who completes the study

Data completion rate

时间窗: 6 months

the percentage of participants who complete all study questionnaires and follow up contacts

Recruitment rate

时间窗: 6 months

The percentage of potential participants agree to consent to the study

次要结局

  • The number of suicidal behaviour events(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zainab Samaan (Zena)

Associate Professor

St. Joseph's Healthcare Hamilton

研究点 (2)

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