Mind Body Interventions for the Student Population

This crossover randomized design study's objective is to see if mind body interventions can help students on a college campus manage their chronic pain and/or PTSD. Participants will attend 10 mind body skills group sessions that are 2 hours each. These group sessions teach a variety of ways (skills) for people to express their feelings. A licensed doctor, who is certified to teach mind-body skills group classes, will lead the skills group. Participants will be assessed with an anxiety questionnaire, a chronic pain measure and a measure of heart rate variability.

There will be two groups. Group 1 will begin intervention after baseline testing and will receive follow-up skill sessions once every month for 6 months. The first group will also attend bonus classes during the next 6 months. The second group will do baseline testing and no intervention for the first 10 weeks. They will then participate in the skills groups the second 10 weeks. There will be 3,6 and 12 month follow up data also taken.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Stress; Anxiety
• Intervention / Treatment: Behavioral: Mind body skills

Detailed Description

Students on campus will be made aware of the study through fliers posted on campus. If they contact the study representatives to participate, they will fill out a screening questionnaire that will determine their symptoms and care they are currently receiving. Those that meet the inclusion criteria will be assigned to Group 1 or 2 randomly. The mind body skills groups will be 10 weeks long. Group 1 will participate in mind body interventions immediately, and Group 2 will continue with their usual care for the 10 weeks. After the first session, Group 2 will complete the mind body intervention sessions. The research will therefore be a crossover randomized design where each group will serve as its own control, and also may be compared to the other group. Participants in either group will still be allowed to participate in any care they are currently receiving outside of the mind body intervention, including but not limited to counseling or a support group or therapy. Also, after these groups are over, the first group will continue to have "reunion groups" once per month for 6 months and the second group will not. Reunion groups will consist of supplementary mind body skills group sessions that reinforce skills learned in the original mind body skills groups and also work on retention of knowledge beyond the program. Outcome measures will be taken pre and post mind body skills group, and then at 3, 6, and 12 months after the 10 week mind body skills group ends.

The topics for each session is based upon the Centers for Mind Body Medicine model. Both groups will follow this same weekly topic schedule.

1. Introduction and Drawings
2. Autogenic Training and Biofeedback
3. Guided Imagery
4. Meditation
5. Mobilizing, Transforming, and Celebrating Emotion
6. Genograms part 1
7. Genograms part 2
8. Mindful Eating and Healthy Nutrition
9. Spirituality
10. Closing Drawings and Ritual

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44555
      • Youngstown State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: Selection criteria includes:

Students aged 18-65 who own a smartphone that is able to download the HRV4Training app.

Students must be enrolled in graduate or undergraduate classes on Youngstown State University's campus.

Exclusion Criteria: students that have had previous experience with mind body skills groups or stress reduction interventions within the past 12 months.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Initial participants in the 10 mind body sessions	Behavioral: Mind body skills; 2 hour skill sessions that focus on mindfulness: The topics for each session is based upon the Centers for Mind Body Medicine model. Both groups will follow this same weekly topic schedule.; Introduction and Drawings; Autogenic Training and Biofeedback; Guided Imagery; Meditation; Mobilizing, Transforming, and Celebrating Emotion; Genograms part 1; Genograms part 2; Mindful Eating and Healthy Nutrition; Spirituality; Closing Drawings and Ritual
Active Comparator: Group 2; 10 week no intervention groups - receives the mind body interventions after group 1 has completed.	Behavioral: Mind body skills; 2 hour skill sessions that focus on mindfulness: The topics for each session is based upon the Centers for Mind Body Medicine model. Both groups will follow this same weekly topic schedule.; Introduction and Drawings; Autogenic Training and Biofeedback; Guided Imagery; Meditation; Mobilizing, Transforming, and Celebrating Emotion; Genograms part 1; Genograms part 2; Mindful Eating and Healthy Nutrition; Spirituality; Closing Drawings and Ritual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC)	Questionnaire	Pre intervention, post intervention, 3,6,12 month followup
Change in Graded Chronic Pain Scale	Questionnaire	Pre intervention, post intervention, 3,6,12 month followup
Change in Patient Health Questionnaire - 9 (PHQ 9),	Questionnaire	Pre intervention, post intervention, 3,6,12 month followup
Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15)	Questionnaire	Pre intervention, post intervention, 3,6,12 month followup
Change in Heart rate variability	Measure of heart rate change over time taken with an ap on a cell phone.	Pre intervention, post intervention, at the start of each session, 3,6,12 month followup

Collaborators and Investigators

• Sponsor: Youngstown State University
• Investigators: Principal Investigator: Nancy Landgraff, PhD, Youngstown State University

Publications and helpful links

General Publications

• Brennstuhl MJ, Tarquinio C, Montel S. Chronic Pain and PTSD: Evolving Views on Their Comorbidity. Perspect Psychiatr Care. 2015 Oct;51(4):295-304. doi: 10.1111/ppc.12093. Epub 2014 Nov 24.
• Libby DJ, Pilver CE, Desai R. Complementary and Alternative Medicine Use Among Individuals with Posttraumatic Stress Disorder. Psychol Trauma. 2013;5: 277-285.
• Robert-McComb JJ, Cisneros A, Tacon A, Panike R, Norman R, Qian XP, McGlone J. The Effects of Mindfulness-Based Movement on Parameters of Stress. Int J Yoga Therap. 2015;25(1):79-88. doi: 10.17761/1531-2054-25.1.79.

Helpful Links

• website
• website

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 157-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No