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Investigating the Physiological, Cognitive, and Psychological Effects of a Cognitive-Based Intervention (IPCPE-Mind)

This study is not yet open for participant recruitment.
Verified September 2016 by Dawn Good, Brock University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906449
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dawn Good, Brock University
  Purpose
The primary purpose of this study is to investigate the effectiveness of a brief mindfulness-based intervention for targeting chronic physiological underarousal and post-concussive symptoms following a mild head injury (MHI), as self-reported by undergraduate university students. For the purposes of this study, MHI is defined (and identified) through our demographic questionnaire as a traumatic-based injury to the head - "Have you ever hit your head with a force sufficient to alter your state of consciousness" (consistent with the Kay et al., 1993 criteria/definition; American Congress of Rehabilitation Medicine - ACRM). The investigators exclude congenital or genetic injuries.

Condition Intervention
Brain Concussion, Post-Concussion Syndrome Behavioral: Meditation Technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigating the Physiological, Cognitive, and Psychological Effects of a Cognitive-Based Intervention

Resource links provided by NLM:


Further study details as provided by Dawn Good, Brock University:

Primary Outcome Measures:
  • Five Facet Mindfulness Questionnaire [ Time Frame: 5 weeks from the beginning of the study ]
    The FFMQ is a trait measure of mindfulness (end point minus baseline)

  • Beck Depression Inventory - 2 [ Time Frame: 5 weeks from the beginning of the study ]
    Measures the intensity of depressive symptoms (end point minus baseline)

  • Beck Anxiety Inventory [ Time Frame: 5 weeks from the beginning of the study ]
    Measures the intensity of anxiety symptoms (end point minus baseline)

  • Autonomic Presentation [ Time Frame: 5 weeks from the beginning of the study ]
    Sympathetic Nervous System measures - EDA, heart rate, blood pressure

  • Toronto Mindfulness Scale [ Time Frame: 5 weeks from the beginning of the study ]
    Measure of state mindfulness (end point minus baseline)


Secondary Outcome Measures:
  • Trail Making Test [ Time Frame: 5 weeks from the beginning of the study ]
    An index of non-verbal cognitive flexibility

  • Color-Word Interference Test [ Time Frame: 5 weeks from the beginning of the study ]
    Measures attention and inhibitory control

  • Behaviour Rating Inventory of Executive Function - Adult version [ Time Frame: 5 weeks from the beginning of the study ]
    Measures self-report deficits in executive functioning

  • HEXACO Personality Inventory - Revised [ Time Frame: 5 weeks from the beginning of the study ]
    Assesses the six major dimensions of personality


Estimated Enrollment: 70
Study Start Date: October 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Training
Daily Mindfulness Training - both in-class lectures (weekly) and self-study (daily) over 3 weeks
Behavioral: Meditation Technique
Alertness training or relaxation training
Active Comparator: Relaxation Meditation Training
Daily Relaxation Meditation Training - both in-class lectures (weekly) and self-study (daily) over 3 weeks
Behavioral: Meditation Technique
Alertness training or relaxation training

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Students enrolled in University

Exclusion Criteria:

  • Individuals with food allergies associated with chocolate
  • Individuals with skin sensitivities (e.g., with respect to electrode conductive gel)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906449


Contacts
Contact: Dawn E Good, PhD, CPsych 905-688-5550 ext 3869 dawn.good@brocku.ca

Sponsors and Collaborators
Brock University
Investigators
Principal Investigator: Dawn E Good, PhD, CPsych Brock University
  More Information

Publications:
Bishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J., ... & Devins, G. (2004). Mindfulness: A proposed operational definition. Clinical psychology: Science and practice, 11(3), 230-241.
Short, M. M., Mazmanian, D., Oinonen, K., & Mushquash, C. J. (2016). Executive function and self-regulation mediate dispositional mindfulness and well-being. Personality and Individual Differences, 93, 97-103. doi:10.1016/j.paid.2015.08.007
Bonow, R.O., Mann, D.L., Zipes, D.P., & Libby, P. (2012). Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine. 9th ed. New York: Saunders.

Responsible Party: Dawn Good, Principal Investigator, Brock University
ClinicalTrials.gov Identifier: NCT02906449     History of Changes
Other Study ID Numbers: DGBrockU
First Submitted: September 15, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only congregate/group statistical data will be shared and published

Keywords provided by Dawn Good, Brock University:
concussion, mild head injury, mindfulness

Additional relevant MeSH terms:
Brain Concussion
Post-Concussion Syndrome
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating