Journeys to Wellness: A Transplant Candidate Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01254214
First received: September 27, 2010
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.


Condition Intervention Phase
End-stage Renal Disease
Behavioral: tMBSR
Behavioral: Support group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • State-Trait Anxiety Inventory [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]
    self-reported anxiety symptoms


Secondary Outcome Measures:
  • Short Form -12 [ Time Frame: 6 and 26 weeks ] [ Designated as safety issue: No ]
    Measure self-perceived mental and physical health status

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]
    A measure of self-reported sleep quality over the past month

  • Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]
    A self-reported measure of symptoms of depression


Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: August 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tMBSR
telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
Behavioral: tMBSR
MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8.
Other Name: None applicable
Active Comparator: Support Group
The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Behavioral: Support group
The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Candidate on the United Network for Organ Sharing (UNOS) wait list for a kidney or kidney-pancreas or evaluated as eligible for candidacy at the UMN
  • Aged 18 or older
  • English-speaking
  • Literate
  • Mentally intact
  • Able to use the telephone to participate in 6 weekly teleconferences
  • Able to attend 2 in-person classes in a Minnesota Metro area
  • Able to comply with study monitoring requirements
  • Receiving standard medical follow-up care
  • Willing to complete the informed consent process

Exclusion Criteria:

  • Prior transplant
  • Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major non-transplant surgery planned in the next 3 months)
  • Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse
  • Not expected to be on the waiting list > 3 months (e.g., acceptable living donor has been identified and scheduled)
  • Prior MBSR class or regularly practicing mindfulness meditation (twice a week or more)
  • Not receiving standard medical care.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254214

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Cynthia R Gross, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01254214     History of Changes
Other Study ID Numbers: 0907S70361, 2P01DK013083
Study First Received: September 27, 2010
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Mindfulness
Quality of life
Transplantation
Renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014