Mind Body Interventions for the Student Population

NCT03756701 | Completed

• 1 other identifier: 157-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Anxiety; Stress

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Initial participants in the 10 mind body sessions

Behavioral: Mind body skills

Group 2

ACTIVE COMPARATOR

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

Behavioral: Mind body skills

Interventions

Mind body skills BEHAVIORAL

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. 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

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Related Publications (3)

• 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.

  PMID: 25420926 BACKGROUND

• Libby DJ, Pilver CE, Desai R. Complementary and Alternative Medicine Use Among Individuals with Posttraumatic Stress Disorder. Psychol Trauma. 2013;5: 277-285.

  BACKGROUND

• 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.

  PMID: 26667291 BACKGROUND

Related Links

• website
• website

MeSH Terms

Conditions

Chronic Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Nancy Landgraff, PhD

  Youngstown State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 28, 2018
• Study Start: September 15, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)