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Mind Body Interventions for the Student Population

Primary Purpose

Chronic Pain, Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind body skills
Sponsored by
Youngstown State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Youngstown State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Initial participants in the 10 mind body sessions

10 week no intervention groups - receives the mind body interventions after group 1 has completed.

Outcomes

Primary Outcome Measures

Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC)
Questionnaire
Change in Graded Chronic Pain Scale
Questionnaire
Change in Patient Health Questionnaire - 9 (PHQ 9),
Questionnaire
Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15)
Questionnaire
Change in Heart rate variability
Measure of heart rate change over time taken with an ap on a cell phone.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2018
Last Updated
April 27, 2021
Sponsor
Youngstown State University
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1. Study Identification

Unique Protocol Identification Number
NCT03756701
Brief Title
Mind Body Interventions for the Student Population
Official Title
Mind Body Interventions for the Student Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Youngstown State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Anxiety, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Initial participants in the 10 mind body sessions
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
10 week no intervention groups - receives the mind body interventions after group 1 has completed.
Intervention Type
Behavioral
Intervention Name(s)
Mind body skills
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC)
Description
Questionnaire
Time Frame
Pre intervention, post intervention, 3,6,12 month followup
Title
Change in Graded Chronic Pain Scale
Description
Questionnaire
Time Frame
Pre intervention, post intervention, 3,6,12 month followup
Title
Change in Patient Health Questionnaire - 9 (PHQ 9),
Description
Questionnaire
Time Frame
Pre intervention, post intervention, 3,6,12 month followup
Title
Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15)
Description
Questionnaire
Time Frame
Pre intervention, post intervention, 3,6,12 month followup
Title
Change in Heart rate variability
Description
Measure of heart rate change over time taken with an ap on a cell phone.
Time Frame
Pre intervention, post intervention, at the start of each session, 3,6,12 month followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Landgraff, PhD
Organizational Affiliation
Youngstown State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25420926
Citation
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.
Results Reference
background
Citation
Libby DJ, Pilver CE, Desai R. Complementary and Alternative Medicine Use Among Individuals with Posttraumatic Stress Disorder. Psychol Trauma. 2013;5: 277-285.
Results Reference
background
PubMed Identifier
26667291
Citation
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.
Results Reference
background
Links:
URL
https://www.ptsd.va.gov/public/PTSD-overview/basics/how-common-is-ptsd.asp
Description
website
URL
https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd
Description
website

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Mind Body Interventions for the Student Population

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