Clinical trial NCT03704779: Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress
Official title: Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Mindfulness
Student
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Student Stress Management Questionnaire
timeFrame: 10 minutes
measure: Daily Log
timeFrame: 10 minutes
measure: Grade Point Average (GPA)
timeFrame: 5 minutes
measure: Number of Student Wellness Center Visits
timeFrame: 5 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Sharon A Gutman, PhD
role: PRINCIPAL_INVESTIGATOR
References: