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Journeys to Wellness: A Transplant Candidate Study

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ClinicalTrials.gov Identifier: NCT01254214
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
End-stage Renal Disease Behavioral: tMBSR Behavioral: Support group Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. State-Trait Anxiety Inventory [ Time Frame: Baseline, 8 weeks, 26 weeks ]
    The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.


Secondary Outcome Measures :
  1. Short Form -12 MCS [ Time Frame: baseline, 8 and 26 weeks ]
    Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.

  2. SF-12 PCS [ Time Frame: baseline, 8 weeks, 26 weeks ]
    Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline, 8 weeks, 26 weeks ]
    The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.

  4. Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: baseline, 8 weeks, 26 weeks ]
    The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01254214


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Cynthia R Gross, PhD University of Minnesota - Clinical and Translational Science Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01254214     History of Changes
Other Study ID Numbers: 0907S70361
2P01DK013083 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2010    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency