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Completed

NCT Number: NCT03756701

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.

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Key information

Conditions

Chronic Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Youngstown State University

Youngstown, Ohio, 44555, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

  • 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 outcomes

  1. Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC)

    Time frame: Pre intervention, post intervention, 3,6,12 month followup

    Questionnaire

  2. Change in Graded Chronic Pain Scale

    Time frame: Pre intervention, post intervention, 3,6,12 month followup

    Questionnaire

  3. Change in Patient Health Questionnaire - 9 (PHQ 9),

    Time frame: Pre intervention, post intervention, 3,6,12 month followup

    Questionnaire

  4. Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15)

    Time frame: Pre intervention, post intervention, 3,6,12 month followup

    Questionnaire

  5. Change in Heart rate variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Youngstown State University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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