Healthy Student Initiative

Depressive Self-Criticism Clinical Trial

Official title:

Healthy Student Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164708
• Other study ID #: 2012 - 170
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: June 13, 2014
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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:

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Self-Criticism

Intervention

Behavioral:
• Mindfulness Meditation
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.

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
York University	Federal Economic Development Agency for Southern Ontario

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Ritvo, P., Vora, K., Irvine, J., Mongrain, M., Azargive, S., Muhammad Abid, A., … Cribbie, R. (2013). Reductions in Negative Automatic Thoughts in Students Attending Mindfulness Tutorials Predicts Increased Life Satisfaction. International Journal of Educ

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of Mood States	Inventory to assess mood states	6 months	No
Secondary	Anxiety Sensitivity	Inventory to assess anxiety sensitivity	6 months	No

External Links

•   Website to coordinate recruitment, intervention, and data collection