Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress

Stress Clinical Trial

Official title:

Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704779
• Other study ID #: AAAS0303
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: April 11, 2019

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance. This study will use a two group, randomized controlled design in which approximately 25 students will be randomized to an intervention group and 25 to a control group. Intervention will be implemented in an 8-week period with pre- and post-study measures administered at 1-week prior to and 1-week following intervention.

Description:

College students have reported increasing stress levels in the last 5 years with 1 in 6 students experiencing anxiety levels that adversely impact school function. This study's intervention uses a variety of media and both online and in-person delivery strategies. For example, students will have the opportunity to participate in yoga, Tai Chi, guided imagery meditation, creative arts, journaling, and pet therapy. Students will additionally have the opportunity to participate in activities delivered through online media and accessible at all times throughout the study. Approximately 50 occupational and physical therapy students will be recruited to participate in this study. Half will be selected by chance to participate in the 8-week program; the remaining half will be selected by chance to participate in a non-intervention group in which they do not receive the program but are still assessed at pre- and post-program to measure perceived stress levels. It is anticipated that study results will provide information to educational institutions to help students better manage stress levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Participants will be student volunteers in the Columbia University Physical and Occupational Therapy Programs.

• Students must be in their first or second year, second semester in order to compare GPA pre- and post-intervention.

Exclusion Criteria:

• Students who are practiced meditators or who have prior experience with mindfulness training will be excluded from study participation, as such previous experience could bias intervention results.

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Multimodal mindfulness activity program
This program will provide the opportunity for participants to engage in in-person and online activities. The in-person activities will be held from 12:00 pm to 12:45 pm in the Georgian Physical Therapy Lab (and offered twice per week). The online activities will be available at all times during the study at convenience. There are one 40-minute in-person and four 10-minute online mindfulness activities per week (combined time of 1 hour and 20 minutes per week). In-person activities will consist of mindfulness activities including guided imagery meditation, yoga, Tai Chi, progressive muscle relaxation, creating a Zen garden, aromatherapy, journaling, self-massage, and pet therapy. Online materials will additionally include guided and unguided meditations.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale	The Perceived Stress Scale (PSS) is a 10-item, 5-point, self-report Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete. The scale yields a total score ranging from 0 (no stress) to 50 (highest stress) with scores 25+ indicating a possible stress disorder. The PSS measures stress level in the last month and was intended for use by community-dwelling adults.	10 minutes
Secondary	Student Stress Management Questionnaire	The Student Stress Management Questionnaire (SSMQ) is a 12-item, 5-point Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete. The scale yields a total score ranging from 0 (no stress) to 60 (highest stress) with scores 40+ indicating a possible stress disorder. The SSMQ measures stress level in the last month and was intended for use by college students.	10 minutes
Secondary	Daily Log	The daily log is a 6-item questionnaire that allows students to record the number and length of mindfulness activities in which they participated that day. Students also report their level of stress before and after participation using a 5-point Likert scale (0 = no stress, 5 = high stress). Scores of 15+ indicate higher stress levels.	10 minutes
Secondary	Grade Point Average (GPA)	GPA will be calculated for the semester prior to and directly after study participation.	5 minutes
Secondary	Number of Student Wellness Center Visits	The number of Student Wellness Center visits prior to and directly after study participation will be collected.	5 minutes