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Mind Body Interventions for the Student Population

Sponsor
Youngstown State University (Other)
Overall Status
Completed
CT.gov ID
NCT03756701
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
7.5
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mind body skills
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
There will be 2 groups of participants. Group 1 will begin the intervention immediately. Group 2 will maintain their usual lifestyle for the first 10 weeks, and begin group sessions when group 1 has completed. There will be "refresher sessions" for group 1 once per month, and 3, 6 12 month follow up testing after the group sessions.There will be 2 groups of participants. Group 1 will begin the intervention immediately. Group 2 will maintain their usual lifestyle for the first 10 weeks, and begin group sessions when group 1 has completed. There will be "refresher sessions" for group 1 once per month, and 3, 6 12 month follow up testing after the group sessions.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mind Body Interventions for the Student Population
Actual Study Start Date :
Sep 15, 2018
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC) [Pre intervention, post intervention, 3,6,12 month followup]

    Questionnaire

  2. Change in Graded Chronic Pain Scale [Pre intervention, post intervention, 3,6,12 month followup]

    Questionnaire

  3. Change in Patient Health Questionnaire - 9 (PHQ 9), [Pre intervention, post intervention, 3,6,12 month followup]

    Questionnaire

  4. Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15) [Pre intervention, post intervention, 3,6,12 month followup]

    Questionnaire

  5. Change in Heart rate variability [Pre intervention, post intervention, at the start of each session, 3,6,12 month followup]

    Measure of heart rate change over time taken with an ap on a cell phone.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Youngstown State University Youngstown Ohio United States 44555

Sponsors and Collaborators

  • Youngstown State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Nancy Landgraff, Professor, Youngstown State University
ClinicalTrials.gov Identifier:
NCT03756701
Other Study ID Numbers:
  • 157-18
First Posted:
Nov 28, 2018
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Chronic Pain

Study Results

No Results Posted as of Apr 28, 2021