Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress

NCT03704779 | Completed

• 1 other identifier: AAAS0303
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress

Keywords

Mindfulness; Student

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Student Stress Management Questionnaire

  10 minutes

• Daily Log

  10 minutes

• Grade Point Average (GPA)

  5 minutes

• Number of Student Wellness Center Visits

  5 minutes

Study Arms (2)

Multimodal Mindfulness Activity Program

EXPERIMENTAL

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

Behavioral: Multimodal mindfulness activity program

Control Group

NO INTERVENTION

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

Interventions

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.

Multimodal Mindfulness Activity Program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Study Officials

• Sharon A Gutman, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors will be masked to participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation and Regenerative Medicine (OT, Rehab & Regenerative Med)

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: February 1, 2019
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)