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Completed

NCT Number: NCT03704779

Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress

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.

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Key information

Conditions

Stress

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Multimodal mindfulness activity program

Behavioral

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.

Primary outcomes

  1. Perceived Stress Scale

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. Student Stress Management Questionnaire

    Time frame: 10 minutes

    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.

  2. Daily Log

    Time frame: 10 minutes

    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.

  3. Grade Point Average (GPA)

    Time frame: 5 minutes

    GPA will be calculated for the semester prior to and directly after study participation.

  4. Number of Student Wellness Center Visits

    Time frame: 5 minutes

    The number of Student Wellness Center visits prior to and directly after study participation will be collected.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Apr 12, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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