跳至主要内容
临床试验/NCT03473535
NCT03473535进行中(未招募)不适用

The BEACON Study: Protocol for a Pilot Randomized Controlled Trial of Smartphone-assisted Problem Solving Therapy in Men Who Present With Intentional Self-harm to Emergency Departments in Ontario

University of Ottawa2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
2
主要终点
Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS)

研究概览

简要总结

The purpose of this study is to evaluate the use of problem-solving therapy (PST), supplemented by a smartphone application, in the treatment of men who present to the Emergency Departments in Ontario. A total of 100 men in 5 Emergency Departments will be enrolled and randomized to receive either face-to-face PST or face-to-face PST supplemented by the BEACON Suicide Prevention smartphone application. Face-to-face therapy may be provided via videoconference to accommodate patient preference and ongoing pandemic restrictions. Participants will complete six sessions of PST and outcomes will be measured at baseline, 6 weeks, two post-therapy follow-up time points (3 and 6 months). Participants will also be asked to complete a qualitative interview about their participation in the study and their experience with the smartphone application.

详细描述

Self-harm is defined as intentional self-poisoning or self-injury, whether or not there is evidence that the act was intended to result in death. In the past, the term used was 'attempted suicide.' However, peoples' motives for harming themselves are highly variable, a person may have more than one motive and motivation is hard to assess. In line with usual public policy in health and social care, we use the term 'self-harm' to describe a behaviour - avoiding the word 'deliberate' because many service users or consumers dislike its connotations.

In Ontario, the number of people who present to hospital emergency departments (ED) with self-harm is difficult to accurately assess and often underreported. Data from CIHI results in an estimated 8,250 ED visits annually (as of 2014) in Ontario. However, using data from Ottawa, Ontario EDs the rate of presentation appears to be more than double at 1,600 presentations annually. Therefore, it is possible that the provincial rate may exceed 16,000 unique presentations. The most common form of self-harm seen in emergency departments (around 80% of episodes) is the intentional consumption of an excess of a medicinal or toxic product, whether or not there is evidence that the act was intended to result in death. Injuries, most commonly self-cutting, form 15-20% of episodes.

Two-thirds of people attending emergency departments because of self-harm are under 35 years of age. They are high users of health and social care services. Self-harm also has a strong association with suicide: 7 patients per 1000 (approximately 1.6%) die by suicide in the year after attending emergency departments with a non-fatal episode, with the incidence rate nearly double in men compared to women, representing a risk nearly 50 times greater than the general population. All-cause mortality is also higher for individuals who self-harm, with significantly more deaths from natural causes and accidents than in the general population. As such, self-harm is associated with a 40-year reduction in average life expectancy. Whilst only four of ten people who present with self-harm are men, they account for nearly two-thirds of suicides after an episode and are far more likely than women to die a premature death from other causes. The rates are even more pronounced in indigenous communities, with suicide rates of 126 per 100,000 young men (15-24) compared to a rate of 24 per 100,000 in non-Indigenous men of the same age.

Approximately 10% of those who present in an Emergency Department following self-harm will engage in repeat self-harm in the following month and up to 27% after six months. Recurrent self-harm is associated with significant distress and many unresolved interpersonal problems. It is likely that any reduction in repetition of self-harm will be mirrored by a fall in subsequent suicides. The Canadian Association for Suicide Prevention blueprint for a National Suicide Prevention Strategy (CASP) has identified those who have presented to the hospital with non-fatal self-harm as a high-risk target group to reduce suicide.

People attending emergency departments after self-harm receive a variable standard of care in Ontario, and there is no standard protocol for therapy. Many are not assessed for psychological needs, and the little psychological therapy available is not usually covered by Ontario Health Insurance (OHIP). Local data from hospitals in Ottawa show that only 4 out of 10 men who present with intentional self-harm are seen by a mental health professional. Few are offered an evidence-based treatment aimed at reducing their risk of suicide or repeated self-harm. Assessment of suicide risk is currently a Required Operating Practice for Canadian Hospital accreditation; however, individuals identified as at-risk for suicide rarely receive recommended care.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Identifies as Male.
  • 18 years of age or older.
  • Has presented via the Emergency Department with self-harm in the preceding 4 weeks
  • Able to read and understand English, French or read or understand Oji Cree.
  • Willing to attend six problem-solving therapy sessions for a period of up to eight weeks.
  • Willing to use a smartphone application to facilitate the treatment of self-harm.
  • Willing to return to the hospital for follow-up appointments.
  • Willing and able to provide informed consent.
  • Willing to use e-mail for study activities.

排除标准

  • Identifies as female.
  • Has presented to the Emergency Department for a reason other than self-harm.
  • In the opinion of the investigator is unlikely to commit to a six-month long study.

结局指标

主要结局

Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS)

时间窗: Baseline; Session 6; 3 months; 6 months Post-Enrollment.

Self-reported measurement of the current intensity of a participant's attitudes, behaviours, and plans to die by suicide during the past week. It consists of 5 screening items, and 19 follow-up items. Each item is scored from 0 (moderate to strong) to 2 (none), yielding a total score ranging from 0 to 48, with higher scores indicating a higher risk of suicidality. Generally, scores above 24 are considered to be a clinical cutoff implying that the respondent is at significant risk for suicide.

次要结局

  • Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Emotional Control Sub-Scale(Baseline Visit)
  • Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentations to the Hospital for Any Reason Other Than Self-Harm(6 months Post-Enrollment.)
  • Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Primary Care Visits.(6 months Post-Enrollment.)
  • Change in Severity of Anxiety Symptoms - 7-Item General Anxiety Disorder Questionnaire (GAD-7)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Meaning in Life - 40-Item Experienced Meaning in Life Questionnaire (EMIL): Four sub-scales (Creative, Experiential, Attitudinal, Ultimate)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Alcohol Misuse - 10-Item Alcohol Use Disorder Identification Test (AUDIT)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Drug Misuse - 10-Item Drug-Abuse Screening Test (DAST-10)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Self-Reliance Sub-Scale(Baseline Visit)
  • Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)(Baseline; Session 6; 3 months; 6 months Post-Enrollment)
  • Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Severity of Depression Symptoms - 9-Item Patient Health Questionnaire (PHQ-9)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Perceived Social Supports - 12-Item Multidimensional Scale of Perceived Social Supports (MSPSS)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Problem-Solving Skills - 25-Item Social Problem Solving Inventory - Revised Short Form (SPSI-R:S)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Post-Traumatic Stress Disorder Symptoms - 5-Item Primary Care Post-Traumatic Stress Disorder Screening Tool for DSM-5 (PC-PTSD-5)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Change in Alcohol Misuse - 3-Item Alcohol Use Disorder Identification Test (AUDIT-C)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)
  • Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Previous Hospitalizations for Self-Harm(6 months Post-Enrollment.)
  • Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentation to Hospital for Self-Harm(6 months Post-Enrollment.)
  • Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Admission to the Hospital for Any Reason.(6 months Post-Enrollment.)
  • Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Outpatient Appointment for Any Reason.(6 months Post-Enrollment.)
  • Health Service Use - Questionnaire on Healthcare Consumption and Productivity losses for patients with a Psychiatric Disorder (TiC-P)(Baseline; Session 6; 3 months; 6 months Post-Enrollment.)

研究者

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

Dr. Simon Hatcher

Vice-Chair, Department of Psychiatry

University of Ottawa

研究点 (2)

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