Clinical trial NCT03756181: Mindfulness and Self-Compassion in McGill University
Official title: A Mixed Methods Evaluation Study of Brief Mindfulness-based Stress Reduction and Brief
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2018-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Current treatments in Canada and at McGill: Some studies suggest that approximately 50% of university students experience significant stress (i.e., a reaction observed in the form of depression and anxiety). It is therefore recommended that universities employ preventative interventions that impact large numbers of students (i.e., group-based interventions) instead of merely relying on individual services to meet student needs. Current treatments for psychological distress offered at Canadian universities include health promotion and accessibility, counseling, and medical services. These are limited by lack of coordination, financial constraints, adequate staffing, and primarily reactive response to focus on problems as they arise.

In McGill University, student's support services include the Peer-Support Centre (PSC), counseling services and psychiatric consultation for more severe cases. At the therapeutic level, counseling services offer vocational and therapeutic workshops, therapeutic groups (i.e., Cognitive Behavioral Therapy and Acceptance and Commitment Therapy), and one-on-one counseling services. However, the current wait-time for students with mental health issues to initially meet a counselor and receive urgent support (i.e., being placed on a therapeutic group) is approximately four weeks. This creates significant pressure for McGill Student Services to offer rapid open-access services to students experiencing stress. In this vein, Student Services not only tackles a student's need for support but also actively engages them in mental health prevention promoting continued well-being. Newer "third wave" programs including mindfulness and compassion-based (i.e., Mindful Self-Compassion) interventions are a promising approach, especially as they have gain popularity in educational settings.

Self-compassion interventions: While some research groups have begun evaluating the use of mindfulness programs in university settings (i.e., MBSR), most studies address populations of medical students rather than overall university-level populations. Yet, novel self-compassion programs remain to be examined. While mindfulness-based interventions focus on the non-judgmental experience of the present moment, compassion-based approaches focus on kindly addressing the suffering experience of the experiencer itself. In light with this, compassion-based approaches foreground cultivating compassion towards self and others, given high levels of self-criticism associated with many mental disorders. Compassion greatly benefits mental health and emotional regulation, improves interpersonal and social relations and is considered a significant predictor of well-being and resilience. Novel programs include Mindful Self-Compassion (MSC) which demonstrates solid endurance and resilience effects, and may theoretically have a more significant impact on university students compared to well-known third wave interventions, such as MBSR.

It is relevant to delineate that MBSR's loving-kindness meditation is different from compassion and self-compassion meditation. In loving kindness, the aim is to develop an affective state of unconditional kindness to all people. In compassion, the aim is to cultivate deep and genuine sympathy for those stricken by misfortune and to develop an earnest wish to ease suffering. In self-compassion, the aim is to soothe and comfort the 'self' when any distressing experience arise, remembering that such experiences are part of being human. In this vein, loving kindness is best explained as our attention for all being to be happy, whereas compassion refers to our attention for all beings (or ourselves, in self-compassion) to be free from suffering.

Recently, studies have addressed self-compassion as a moderator of perfectionism and depression in both adolescence and adulthood suggesting that self-compassion interventions may be useful in determining the effects of maladaptive perfectionism. It also appears that self-kindness and mindfulness serve as a buffer of stress as students claim to receive social support and that self-compassion training has an essential impact on measures of depression, anxiety, general well-being, self-compassion, mindfulness, life satisfaction, social connectedness, optimism, self-efﬁcacy, and rumination. Additionally, self-compassionate students are less afraid of failure and are more likely to train again when they fail, have less academic worry and also have a greater sense of self-efficacy. This portrays the student's ability to handle social and academic struggles more effectively, report less depression and homesickness, as well as more satisfaction about their choice of study while at the university.

Limitations to self-compassion interventions: effectiveness and implementation science. To our knowledge, the only study that has examined the effect of MSC in university students was a brief version of MSC compared to a time management intervention in 51 college females. Findings from this study include significantly more significant gains in self-compassion (21%), mindfulness, optimism, self-efficacy and decreases in rumination, strongly suggesting that short versions of MSC may have a substantial potential to improve psychological well-being and resilience of university students. Results from this study, also include medium to high effect size for self-compassion (r=1.19), mindfulness-awareness without judgement (r=0.70), mindfulness-non-reactivity to inner experience (r= 1.20), optimism (r=0.66), self-efficacy (r=0.52), and rumination (r=0.70). Although these effect size measures are of importance, the sample was too small to further determine the effects of the program and interestingly, necessary measures of psychological and vocational influence (both crucial to academic success) were not thoroughly addressed. Furthermore, there are no studies examining impact factors of program implementation (i.e., those associated to student's participation of self-compassion programs), despite a growing interest in implementation science in the educational setting and mental health prevention field. In this study, we will address the issues above to better examine the comparative effectiveness of MSC to MBSR.

Using a mixed methods approach, including a randomized controlled trial and an in-depth qualitative interview, this study will assess the comparative efficacy of newly developed brief Mindful Self-Compassion (MSC) and Mindfulness-based Stress Reduction (MBSR) programs on improving stress in university students. Factors impact group adherence (retention and home practice) will also be explored. Participant's experience of stress and the comparative experience of students participating in both groups will be explained.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* • 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

Primary outcomes:
measure: Perceived Stress
timeFrame: Change in PSS from 0 to 5-weeks (baseline to post-1).
Secondary outcomes:
measure: Self-compassion
timeFrame: Change in SCS from 0 to 5-weeks (baseline to post-1).
measure: Mindfulness
timeFrame: Change in FFMQ from 0 to 5-weeks (baseline to post-1).
measure: Perceived Stress
timeFrame: Change in PSS will be assessed from 0 to 10-weeks (baseline to post-2).
measure: Perceived Stress
timeFrame: Change in PSS will be assessed from 5 to 10-weeks (post-1 to post-2).
measure: Depression
timeFrame: Change in PHQ-9 from 0 to 5-weeks (baseline to post-1).
measure: Anxiety
timeFrame: Change in GAD-7 from 0 to 5-weeks (baseline to post-1).
measure: Rumination
timeFrame: Change in RRS from 0 to 5-weeks (baseline to post-1).
measure: Perfectionism
timeFrame: Change in APS-R from 0 to 5-weeks (baseline to post-1).
measure: Connectedness
timeFrame: Change in SCS from 0 to 5-weeks (baseline to post-1).
measure: Optimism
timeFrame: Change in LOT-R from 0 to 5-weeks (baseline to post-1).
measure: Self-efficacy
timeFrame: Change in SES from 0 to 5-weeks (baseline to post-1).
Other outcomes:
measure: Home mindfulness or self-compassion practice
timeFrame: Each week throughout the intervention (weeks 1 through 5)
measure: Fidelity of implementation (FOI)
timeFrame: Each week throughout the intervention (weeks 1 through 5)
measure: Participant's experience of stress
timeFrame: post-1 (at week-5)
measure: Participant's experience in the groups
timeFrame: post-1 (at week-5)
measure: Adverse events
timeFrame: Each week throughout the intervention (weeks 1 through 5)
Locations:
Study officials:
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