Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress

NCT ID: NCT03704779

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-04-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention will be implemented over 8 consecutive weeks and will consist of experiential mindfulness activities that can be accessed in-person and online. In-person mindfulness activities will be available twice per week and last approximately 40 minutes in length. Mindfulness meditation videos posted online will be available 24/7 and last 10-45 minutes. Students will be asked to participate in one 40-minute in-person and four 10-minute online mindfulness activities per week (total of 1 hour and 20 minutes per week).

Week 1. Progressive muscle relaxation, mindfulness meditation, guided imagery.

Week 2. Mindfulness: Zen garden, painting, craftwork.

Week 3. Active Meditation: yoga, Tai Chi.

Week 4. Aromatherapy.

Week 5. Addiction Information and Management Strategies.

Week 6. Positive Psychology Strategies: cognitive reframing techniques.

Week 7. Self-Compassion Strategies: walking meditation, nutritious snacks, self-massage.

Week 8. Pet Therapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data collectors will be masked to participant group assignment.

Study Groups

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Multimodal Mindfulness Activity Program

Students assigned to the intervention will receive 8 weeks of the mindfulness activity intervention.

Group Type EXPERIMENTAL

Multimodal mindfulness activity program

Intervention Type 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.

Control Group

Students assigned to the control group will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Sharon Gutman

Professor of Rehabilitation and Regenerative Medicine (OT, Rehab & Regenerative Med)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon A Gutman, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAS0303

Identifier Type: -

Identifier Source: org_study_id

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