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A Post-Transplant Resilience Intervention

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Cynthia M. Stonnington, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01629069
First received: June 21, 2012
Last updated: January 13, 2013
Last verified: January 2013
History of Changes
  Purpose

The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance of a new 6 week intervention in Arizona for our transplant patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in Arizona.


Condition Intervention
Behavior
Emotions
 Behavioral: Mindfulness based Stress Reduction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Resilience Intervention Involving Mindfulness Training for Transplant Patients and Their Caregivers

Resource links provided by NLM:

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Patient questionaire [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mindfulness based Stress Reduction
    6 weekly group sessions
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient within 6 months of liver, heart, kidney, or bone marrow transplant
  • Caregiver of post-transplant patient

Exclusion Criteria

  • Suicidal
  • Severe cognitive impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629069

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Tisha Pathuis, LCSW     480-342-2161     pathuis.patricia@mayo.edu    
Contact: Cynthia M Stonnington, MD     480-301-4853     stonnington.cynthia@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Cynthia Stonnington, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Cynthia M. Stonnington, M.D., Chair, Department of Psychiatry & Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01629069     History of Changes
Other Study ID Numbers: 12-004988
Study First Received: June 21, 2012
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
stress
mindfulness
coping

ClinicalTrials.gov processed this record on May 23, 2013