Investigating the Efficacy of a Novel Therapy for Suicide Risk in Adults: A Randomized Controlled Trial of an Intensive Single Session of "Brief Skills for Safer Living"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in suicidal ideation using Beck Scale for Suicide Ideation
研究概览
简要总结
The goal of this project is to assess the efficacy of Brief-Skills for Safer Living (Brief-SfSL) in a randomized control trial. The investigators will be testing 150 participants Canada-wide, half of which will be randomized to receive Brief-SfSL (B-TAU) and the other half will be randomized to receive Brief-SfSL after a 3 month waitlist (WL-TAU). The main questions this study seeks to answer are:
- Is B-TAU more efficacious than WL-TAU for reducing suicidal thoughts at 3 months?
- Is B-TAU more efficacious than WL-TAU at 3 months for reducing depression severity, anxiety, and anhedonia?
- Is B-TAU more efficacious than WL-TAU at 3 months for improving social connectedness, emotional regulation, functioning (work, life, social), executive control and social problem-solving?
- Are adverse events equivalent between B-TAU and WL-TAU at 3 months?
详细描述
There are 2 million people in Canada at risk of death from suicide and suicide rates have not changed in the last 10 years. The COVID-19 pandemic also increased suicide risk and intensified a pre-existing lack of access to vital mental health services, with wait lists up to 1 year. To address this issue, the investigators developed "Brief Skills for Safer Living" (Brief-SfSL), a single-session individual psychotherapy intervention with the potential to make it easier to access care and shorten the time for people to access intervention. Derived from the proven success of the original SfSL 20-week group therapy, Brief-SfSL goes beyond conventional approaches by helping individuals understand their suicidal thoughts, build skills to manage these thoughts, and stay safe during crises. The strong results of the investigators single-arm trial of virtually-delivered Brief-SfSL in 77 adults with suicidal ideation across Canada show that Brief-SfSL is a feasible, acceptable, and safe intervention that has the potential to reduce suicide risk. To prove that it is, the investigators need to expand their study to include a treatment as usual (TAU) comparison group in a randomized controlled trial (RCT). The investigators will conduct an RCT that includes 2 groups: 75 participants who will receive TAU plus Brief-SfSL, and 75 who will receive TAU and be on a 3-month wait-list for Brief-SfSL. The aim is to compare the efficacy of Brief-SfSL vs. TAU on suicidal ideation and proxies for suicide risk (e.g., depression, anxiety) over 3 months. If the results confirm the efficacy of Brief-SfSL over TAU, this will provide definitive data to support the broad implementation of Brief-SfSL in hospitals and community mental health agencies across Canada. Study results will also be used to plan trials to assess the long-term impact of Brief-SfSL on suicide risk, healthcare system utilization, and health economics. Through this research, the investigators aim to save lives and also shift the paradigm of mental health intervention on a national scale.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Suicidal ideation in the past week
- •Access to a computer or phone with a camera
- •Access to internet
- •Access to an emergency contact and hospital within commuting distance
- •Not receiving other psychotherapy/counselling services concurrently
- •Willing to have the session recorded to determine therapy fidelity
- •Any psychiatric diagnosis is allowed
- •Follow-up visits with a psychiatrist and/or family doctor where a psychotherapeutic modality (e.g., Dialectical Behavioural Therapy, psychodynamic therapy, etc.) is not being used are allowable
排除标准
- •Inability to undergo psychotherapy in English
- •Presence of cognitive impairment that would limit consent and understanding of Brief Skills for Safer Living or study procedures
- •Active psychosis that impairs capacity to consent, understand study procedures, or participate
- •Unwilling or unable to provide informed consent
- •Previously enrolled in the Brief-SfSL pilot study
- •Unwilling or unable to communicate verbally
研究组 & 干预措施
Brief-SfSL (B-TAU)
Participants will receive the Brief-SfSL treatment within 1 week of their screening.
干预措施: Brief-SfSL (Behavioral)
Wait List (WL-TAU)
Participants will be put on a wait list and receive the Brief-SfSL treatment 3 months after their screening.
结局指标
主要结局
Change in suicidal ideation using Beck Scale for Suicide Ideation
时间窗: From baseline to 3 months post-intervention
Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
次要结局
- Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)(From baseline to 3 months post-intervention)
- Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS).(From baseline to 3 months post-intervention)
- Participant safety as measured by adverse events(Through study completion, an average of 3 months)
- Suicide severity differences between groups as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)(Through study completion, an average of 3 months)
- Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS).(From baseline to 3 months post-intervention)
- Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)(From baseline to 3 months post-intervention)
- Changes in anhedonia using the Dimensional Anhedonia Rating Scale (DARS)(From baseline to 3 months post-intervention)
- Changes in feelings of social connectedness and burdensomeness using the Interpersonal Needs Questionnaire (INQ)(From baseline to 3 months post-intervention)
- Changes in work, social and family functioning using the Sheehan Disability Scale (SDS)(From baseline to 3 months post-intervention)
- Changes in emotional dysregulation using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)(From baseline to 3 months post-intervention)
- Changes in executive control using Space Explorer (gamified behavioural task)(From baseline to 3 months post-intervention)
- Changes in social problem-solving using Jungle Treasure Hunt (gamified behavioural task)(From baseline to 3 months post-intervention)
- Participant safety as measured by adverse events(Through study completion, an average of 3 months)
- Suicide severity differences between groups as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)(Through study completion, an average of 3 months)