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临床试验/NCT03756181
NCT03756181撤回不适用

A Mixed Methods Evaluation Study of Brief Mindfulness-based Stress Reduction and Brief

Lady Davis Institute0 个研究点开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Perceived Stress

研究概览

简要总结

Mental health issues are increasingly costly in Quebec. Given most psychological disorders occur before age 24, university-based interventions are appealing to prevent and treat mental illness, especially as rates of psychological distress have peaked among university students in our province. This at-risk population may benefit from new university-based programs, as academic institutions now face limited staffing and an increasing number of students seeking services. Mindfulness-based Stress Reduction (MBSR) programs are a promising approach, reporting substantial increases in emotional regulation. Novel mindful self-compassion (MSC) programs additionally display increasing improvements in resilience, that could foster stronger well-being in highly competitive academic contexts. A few high-quality scientific studies have investigated the impact of university setting MSC programs, but it remains unclear to determine whether MBSR or MSC may be useful in Canadian student populations experiencing psychological distress. This study will rigorously evaluate both programs efficacy and will be the first one to understand the student's experience in both groups.

详细描述

In Canada, 42 billion dollars are spent per year treating mental health issues. Given that 53% Canadians undergo postsecondary education, the mental health of university students is of great concern, especially as they experience higher proportions of psychological distress ("stress") compared to the general population. Reports indicate a 42.2% of stress levels in university students, which not only poses a significant impact in their academic performance, but also meaningfully contributes to decreased rates of students completing their studies, and in high rates of long-term maladjustment mental illness including depression (15-30%), and anxiety (32.2%). University students are also prone to develop eating disorders (6%), attention-deficit/hyperactivity disorder (4%), post-traumatic stress disorders (3%), drug/substance abuse (2.1%) , and sleep disturbances (5% to 73%).

As the onset of most psychological disorders occurs at age 24, university students may greatly benefit from mental health assistance provided by academic institutions. At McGill University, high rates of psychological distress are experienced by both undergraduate and graduate students, as observed by concerning rates of suicidality (10% of students have considered attempting suicide while at University), trauma (5 to 16%), and testimonials of experiencing social anxiety (61-65 %) and academic distress (55-66%). Moreover, a steady increase in students seeking mental health or counseling services and the increased complexity and severity of symptoms have placed significant attention in the development of strategies addressing university students' psychological well-being.

Implementation science: mental health care in university settings. Many public-sector services systems and provider organizations are in some phase of learning about or implementing evidence-based interventions. Universities represent an optimal setting for reaching young adults with mental health promotion and prevention programs as they are a captive audience, thus reducing adherence problems known to diminish the impact and outcomes of public health interventions in general.

Successful program implementation (i.e., examining the barriers and facilitators of program adherence to an evidence-based program) is directly associated with better outcomes and a translational promise to accelerate knowledge into practice. Efforts to enhance and improve outcome involves ameliorating concordance with evidence-based clinical practice guidelines. However, guidelines for the treatment of mental illnesses are underdeveloped and not routinely well implemented in mental health care, despite the number of evidence-based practices on the rise.

Moreover, studies have found that young people in need of mental health care services show less adherence to prevention and treatment programs, despite the availability of evidence-based practices. In the context of university students, it appears that university students face not only high academic demands and perceived and self-stigmatizing attitudes towards mental illness, but also report limited accessibility (time, transport, and cost) to participate in or adhere to mental health care. Other barriers are related to confidentiality and trust, concern about the characteristics of the provider, difficulty or an unwillingness to express emotion, preferring other sources of help (i.e., family, friends), and worrying about effects on career. In this vein, it remains crucial to systematically study what factors impact program adherence (i.e., attendance on three out of five sessions), and home practice (i.e., continued home practice). Studies also need to understand further how students experience stress and explain the comparative experiences of students participating in different mental health promotion and prevention strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • McGill University Students (Graduate or Undergraduate Students) enrolled or seeking services within McGill Counselling and Mental Health Services
  • Age 18 years or older
  • Students should have sufficient hearing (or assistive devices) to hear verbal instructions and discussion
  • Have an adequate understanding of English and/or French

排除标准

  • • Depression (PHQ9) and anxiety (GAD7) ≥12
  • Acute psychotic symptoms
  • Severe personality problems that will interfere with their ability to function in a group setting
  • Acute Suicidal ideation/intent
  • Student scoring ≥12 on either scale will be immediately referred to therapeutic services offered on campus

研究组 & 干预措施

Five-week MSC program (MSC5wk)

Experimental

This program adaptation will consist of conducted meditative practices, discussions, and background information within a group setting of no more than 25 students per group. The facilitator may discuss the student's experience and encourage group sharing within the course of the session. These discussions will reinforce the guiding principles of compassion: self-kindness, mindfulness, and common humanity, and will work on soothing the processes of self-criticism, self-neglect and perfectionism that are believed to withhold upon experiencing psychological distress. There will also be sessions dedicated to incorporating self-compassion in daily life, with more detailed instructions, as well as encouraging a 30- minute daily home practice.

干预措施: Five-week MSC program (MSC5wk) (Behavioral)

Five-week Mindfulness-based Stress Reduction program (MBSR5wk)

Active Comparator

This program adaptation will consist of conducted meditative practices, discussions, and background information within a group setting of no more than 25 students per group. The facilitator will perform a brief check-in and may discuss the student's experience within the course of the session. These discussions will reinforce the guiding principles of meditation: awareness, non-judgment and acceptance and will work on automatic mental processes that are believed to be at the root of experiencing psychological distress. There will also be sessions dedicated to incorporating mindfulness into daily life, with more detailed instructions, as well as encouraging a 30- minute daily home practice.

干预措施: Five-week MSC program (MSC5wk) (Behavioral)

结局指标

主要结局

Perceived Stress

时间窗: Change in PSS from 0 to 5-weeks (baseline to post-1).

The Perceived Stress Scale (Cohen, Kamarck, \& Mermelstein, 1983; Cohen et al., 1994) is a standardized,10 item self-report questionnaire used to determine the extent to which a person perceives her or his life to be stressful, by taping experiences of distress related to "how unpredictable, uncontrollable, and overloaded respondents find their lives" (Shapiro, Brown, Thoresen, \& Plante, 2011). A sample question is "How often have you found that you could not cope with all the things that you had to do?" Participants responded on a 5-point scale ranging from 1 (never) to 5 (very often). Internal consistency reliability was α = .92.

次要结局

  • Self-compassion(Change in SCS from 0 to 5-weeks (baseline to post-1).)
  • Mindfulness(Change in FFMQ from 0 to 5-weeks (baseline to post-1).)
  • Perceived Stress(Change in PSS will be assessed from 5 to 10-weeks (post-1 to post-2).)
  • Depression(Change in PHQ-9 from 0 to 5-weeks (baseline to post-1).)
  • Anxiety(Change in GAD-7 from 0 to 5-weeks (baseline to post-1).)
  • Rumination(Change in RRS from 0 to 5-weeks (baseline to post-1).)
  • Perfectionism(Change in APS-R from 0 to 5-weeks (baseline to post-1).)
  • Connectedness(Change in SCS from 0 to 5-weeks (baseline to post-1).)
  • Optimism(Change in LOT-R from 0 to 5-weeks (baseline to post-1).)
  • Self-efficacy(Change in SES from 0 to 5-weeks (baseline to post-1).)

研究者

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soham Rej MD, MSc

Assistant Professor, Dept. of Psychiatrist, McGill University

Lady Davis Institute

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