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临床试验/NCT05145582
NCT05145582已完成不适用

Role of Online Discussion Forums in Unguided Internet-Delivered Cognitive Behavioural Therapy for Canadian Public Safety Personnel: A Randomized Trial

University of Regina4 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2021年12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
107
试验地点
4
主要终点
Change in Depression

研究概览

简要总结

This study is a randomized trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet-delivered cognitive behavioural therapy tailored specifically for public safety personnel both with and without a built-in online discussion forum.

详细描述


Background:


The investigators' research unit, PSPNET, is currently providing therapist-guided internet-delivered cognitive behavioural therapy (ICBT) to public safety personnel (PSP) in the Canadian provinces of Saskatchewan, Quebec, Nova Scotia, and New Brunswick. Specifically, PSPNET is offering PSP a transdiagnostic ICBT program for depression, anxiety, and PTSD (the PSP Wellbeing Course), as well as a disorder-specific ICBT program for PTSD (the PSP PTSD Course). ICBT is effective and can help overcome many of the barriers to traditional, face-to-face mental healthcare that PSP face (e.g., concerns about privacy, stigma, distance from services, cost of treatment).

The investigators have created an unguided version of the PSP Wellbeing Course (i.e., no therapist guidance) called the Self-Guided PSP Wellbeing Course. They plan to evaluate this ICBT program through a randomized trial across Canada. Although unguided ICBT does not tend to be quite as effective as guided ICBT, it still consistently results in favorable outcomes compared with control conditions. An important advantage of unguided ICBT is its greater scalability-that is, once created, an unguided ICBT program can be delivered easily on a large scale. Given that PSP face many barriers to mental healthcare, it is expected that participation in this study will help extend treatment to individuals who have not been able to access traditional, face-to-face mental healthcare services. Further, participants will be free to access any other services they see fit while participating in this research.

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

盲法说明

Participants cannot be blinded to condition because ICBT (like other psychotherapies) cannot be both provided to and concealed from a participant. However, the difference between the two conditions (i.e., presence or absence of an online discussion forum) will be concealed from all participants. Because only participants assigned to the ICBT + Peer Support Forum condition will have access to the Peer Support Forum, it will not be possible to mask the forum moderator to those participants' condition. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not possible.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Depression

时间窗: Baseline, 8 weeks, 20 weeks

Patient Health Questionnaire-9. The Patient Health Questionnaire-9 (PHQ-9) is a commonly used measure of depression that includes an item to measure suicidality (Kroenke et al., 2001). It has demonstrated excellent psychometric properties in many studies (e.g., Cameron et al., 2008; Kroenke et al., 2001, 2010). Its nine items are rated on a four-point Likert scale from 0 (not at all) to 3 (nearly every day) for a total score ranging from 0 to 27. Traditionally, a score of 10 or greater has been considered indicative of a likely diagnosis of major depressive disorder on the PHQ-9 (Manea et al., 2012). A change in score of six points has been identified as a reliable change index (National Collaborating Centre for Mental Health, 2019).

Change in Anxiety

时间窗: Baseline, 8 weeks, 20 weeks

Generalized Anxiety Disorder-7. The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item measure of generalized anxiety symptoms. Like the PHQ-9, its items are rated on a four-point Likert scale from 0 (not at all) to 3 (nearly every day). Possible total scores range from 0 to 21. Research shows that the GAD-7 has strong psychometric properties, and a score of 10 or greater can be used to indicate a likely diagnosis of generalized anxiety disorder (Kroenke et al., 2010; Spitzer et al., 2006). Following the precedent of other ICBT researchers, a change in score of five points or more will be considered clinically significant (Titov et al., 2017).

Change in Posttraumatic Stress

时间窗: Baseline, 8 weeks, 20 weeks

PTSD Checklist for DSM-5. The PTSD Checklist for DSM-5 (PCL-5) is a common measure of PTSD that was updated following the release of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; (American Psychiatric Association, 2013; Blevins et al., 2015; Weathers et al., 2013). It includes 20 items that are rated on a five-point Likert scale from 0 (not at all) to 4 (extremely), for a total score between 0 and 80. Several research groups have suggested that a score of 33 or greater indicates a likely diagnosis of PTSD (Bovin et al., 2016; Wortmann et al., 2016). A change in score of 10 points or more is considered a reliable change on the PCL-5 (Byllesby et al., 2019). At baseline (but not at later timepoints), the investigators will administer a version of the PCL-5 that includes five additional questions about the nature of the potentially psychologically traumatic event that a respondent experienced (Weathers et al., 2013).

次要结局

  • Change in Functional Impairment(Baseline, 8 weeks, 20 weeks)
  • Change in Resilience(Baseline, 8 weeks, 20 weeks)
  • Change in Healthcare Use(Baseline, 8 weeks, 20 weeks)
  • Patient-Program Alliance(8 weeks)
  • Change in Wellbeing and Flourishing(Baseline, 8 weeks, 20 weeks)
  • Treatment Satisfaction(8 weeks)
  • Program Use(2 weeks, 4 weeks, 6 weeks, 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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