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临床试验/NCT04140149
NCT04140149已完成不适用

Living With Hope: A Preliminary Investigation of a Novel, CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt

University of Manitoba1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年7月6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
26
试验地点
1
主要终点
Change in scores on the Beck Scale for Suicide Ideation

研究概览

简要总结

This study will determine whether Living with Hope, a novel, 12-week coping skills class, reduces suicidal thoughts and behaviors among individuals who have made a recent suicide attempt. It is hypothesized that participants who complete the class will show significant improvements on measures of suicidal thoughts, hopelessness, and related mental health symptoms, and these improvements will be maintained over time.

详细描述

As the 9th leading cause of death worldwide, suicide is a major public health concern. One of the groups as highest risk of death are those that have previously made a suicide attempt. Effective treatment following a suicide attempt is imperative for reducing the risk of suicide, with increasing evidence showing treatments that target suicide behavior are more effective at reducing risk over treatments that target related mental health difficulties (e.g., depression). However, these treatments are resource intensive and are difficult to access in Manitoba, and many individuals who have made a suicide attempt do not receive any mental health treatment. In order to ensure timely access to treatment following a suicide attempt, we have created a non-resource intensive psychoeducational skills class grounded in evidence-based suicide-specific treatment. The primary aim of this study is to examine the safety and effectiveness of a novel, 12-week cognitive behavior therapy-based, virtual psychoeducational skills class (Living with Hope) in reducing suicidal thoughts and behaviors among adults who have made a recent suicide attempt, and determine whether changes post-treatment are maintained at over time. The secondary aim is to determine whether this intervention also results in improvements on related mental health outcomes, and whether changes on these constructs mediate improvements on suicidal thoughts and behaviors.

Adults ages 18 years and older who have been referred to the Living with Hope class over the 2 year study period will be invited to participate in the proposed study (anticipated n=60). Individuals are eligible for referral if they have made a suicide attempt in the past 3 months and are either seeking mental health crisis services. Participants will complete standardized measures of primary (suicidal thoughts and behaviors) and secondary outcomes (hopelessness, depressive symptoms, emotion regulation difficulties, and quality of life) at pre-treatment, mid-way through the 12-week class, post-treatment, 1-month follow-up, and 3-months follow-up. Mixed-effects linear regression will determine whether there are significant differences on outcome measures at any of these five time-points, as well as whether secondary outcomes mediate improvements on primary outcomes. All research participation will be conducted through virtual means.

The proposed study would be the first in Canada to examine the effectiveness of a low-cost, targeted psychoeducational skills class in reducing suicidal thoughts and behaviors among individuals who have made a recent suicide attempt. This will set the stage for future linkage with administrative data and randomized controlled trials aimed at determining whether the Living with Hope class results in reduced suicide attempts and deaths compared to treatment as usual. If proven safe and effective through these rigorous evaluations, the Living with Hope class could be widely disseminated in the public health system to provide care to a large number of Manitobans, with the long-term goal of increasing access to timely, targeted treatment, and in turn, reducing suicides in Manitoba.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Made a suicide attempt in the past 3 months
  • Sought mental health crisis services, and referred to the Living with Hope program

排除标准

  • Not proficient in English
  • Exhibiting active psychotic symptoms
  • Significant cognitive impairment, are
  • Currently expressing anger or disappointment about the outcome of their attempt,
  • Recent history of violence or verbal aggression towards others, or are exhibiting other signs of behavior that would pose a threat to the safety or wellbeing of class participants
  • Primary substance use disorder -

结局指标

主要结局

Change in scores on the Beck Scale for Suicide Ideation

时间窗: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up

21 item self-report measure of the severity of past-week suicidal ideation

Change in scores on the Columbia-Suicide Severity Rating Scale

时间窗: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up

Clinician-administered interview schedule designed to measure the timing and frequency of suicidal thoughts and behaviors

Suicide attempts

时间窗: Through the duration of treatment and over follow-up period (approximately 6 months)

Presence of a suicide attempt during the study or over the follow-up period, as assessed by the Columbia-Suicide Severity Rating Scale

次要结局

  • Change in scores on the Patient Health Questionnaire-9(Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up)
  • Change in scores on the Difficulties in Emotion Regulation Scale(Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up)
  • Change in scores on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form(Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up)
  • Safety Item(Week 12 of Living with Hope class session)
  • Change in scores on The Beck Hopelessness Scale(Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up)

研究者

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

Christine Henriksen

Assistant Professor

University of Manitoba

研究点 (1)

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