AzTrials
AzTrials

Chronic PainNCT03756701

Mind Body Interventions for the Student Population

A study testing Mind body skills in people with Chronic Pain and Anxiety, run by Youngstown State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Pain, Anxiety, Stress
What is being tested?
Mind body skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
15 Sep 2018to 1 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Youngstown State University

    Youngstown, Ohio, 44555

Other trials in United States

About this study

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.

Read the 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
Being tested
Mind body skills
Medical subject headings
Chronic Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind body skillsBehavioural

    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
Study groups in NCT03756701
Study groupRoleWhat they receive
Group 1ExperimentalInitial participants in the 10 mind body sessions
Receives: Behavioral: Mind body skills
Group 2Active comparator10 week no intervention groups - receives the mind body interventions after group 1 has completed.
Receives: Behavioral: Mind body skills

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Questionnaire

    Measured: Pre intervention, post intervention, 3,6,12 month followup

  2. Change in Graded Chronic Pain Scale

    Questionnaire

    Measured: Pre intervention, post intervention, 3,6,12 month followup

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

    Questionnaire

    Measured: Pre intervention, post intervention, 3,6,12 month followup

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

    Questionnaire

    Measured: Pre intervention, post intervention, 3,6,12 month followup

  5. Change in Heart rate variability

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

    Measured: Pre intervention, post intervention, at the start of each session, 3,6,12 month followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2018
  2. Study start15 Sep 2018
  3. Primary completion1 May 2019
  4. Study completion1 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03756701
Sponsor's protocol ID
157-18
Status last verified
Apr 2021
First submitted
15 Nov 2018
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25420926

  • 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.

    PubMed 26667291

Questions about this trial

What is this clinical trial studying?

A study testing Mind body skills in people with Chronic Pain and Anxiety, run by Youngstown State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC) (time frame: Pre intervention, post intervention, 3,6,12 month followup). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03756701, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in