Mindfulness and Self-Compassion in McGill University

NCT03756181 | Withdrawn

• 1 other identifier: A00-B21-18A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Perceived Stress

  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.

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

Secondary Outcomes (11)

• 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 0 to 10-weeks (baseline to post-2).

• 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).

Other Outcomes (5)

• Home mindfulness or self-compassion practice

  Each week throughout the intervention (weeks 1 through 5)

• Fidelity of implementation (FOI)

  Each week throughout the intervention (weeks 1 through 5)

• Participant's experience of stress

  post-1 (at week-5)

Study Arms (2)

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.

Behavioral: Five-week MSC program (MSC5wk)

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.

Behavioral: Five-week MSC program (MSC5wk)

Interventions

Five-week MSC program (MSC5wk) BEHAVIORAL

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 mindfulness meditation. There will also be sessions dedicated to incorporating or mindfulness in daily life, with more detailed instructions, as well as encouraging a 30- minute daily home practice.

Also known as: Five-week Mindfulness-based Stress Reduction program (MBSR5wk)

Five-week MSC program (MSC5wk); Five-week Mindfulness-based Stress Reduction program (MBSR5wk)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead
• McGill University: collaborator

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dept. of Psychiatrist, McGill University

Model Details: Pilot randomized controlled trial.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: November 28, 2018
• Study Start: March 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share