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Completed

NCT Number: NCT02164708

Healthy Student Initiative

This paper extends prior research by exploring how students with self-critical (SC) traits respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety sensitivity and mood changes during the school year as students attended MM tutorials ii) to study the relationship between self-criticism and MM-related benefits over time. This paper reports on participants' mood and anxiety sensitivity changes before, during, and after the MM program and the association between depressed mood and SC levels. Participants were trained in MM over two continuous semesters, with two specific hypotheses guiding evaluations:

1. Participants overall would report progressive improvements in psychological well-being as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of the MM program. 2. Elevations in self-critical personality traits would predict greater improvements in depressed mood, given the greater need to neutralize cognitive events related to negative moods.

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Key information

Conditions

Depressive Self-Criticism Behavior Personal Satisfaction Psychological Well-Being

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York University

Toronto, Ontario, M3J 1P3, Canada

About this study

A total of 71 undergraduate students in a large public university participated in weekly MM sessions through the Fall & Winter semesters of the 2012/2013 academic year. Recruitment was facilitated through in-class announcements and poster and print advertisements. Online and paper surveys elicited self-report data (reflecting mental health profiles) at program initiation which served as baseline measures for the September-October study period, written informed consent was also obtained during this time. Inclusion criteria included: 1) currently enrolled (part-time-full-time); 2) computer access at the university or elsewhere and/or smartphone access Following a standard within-subjects design, participants were required to complete the psychological measures at 3 additional assessment periods; Time 2 (November-December), Time 3 (January-February), and Time 4 (March-April). To alleviate demands on the students partaking in weekly MM sessions, follow-up assessments were provided in paper and electronic form and completed autonomously. Study participants were given $50 cash payments for full study participation and the study met the ethical guidelines and received approval from the Human Participants Review Subcommittee of the university site where the study was conducted.

The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently enrolled (part-time-full-time) OR current staff members at university
  • Computer access at the university or elsewhere and/or smartphone access

Exclusion criteria

Treatment and study plan

Mindfulness Meditation

Behavioral

The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice.

Primary outcomes

  1. Profile of Mood States

    Time frame: 6 months

    Inventory to assess mood states

Secondary outcomes

  1. Anxiety Sensitivity

    Time frame: 6 months

    Inventory to assess anxiety sensitivity

Sponsors and collaborators

Lead sponsor

York University

Other

Collaborators

  • Federal Economic Development Agency for Southern Ontario

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2014
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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