Journeys to Wellness: A Transplant Candidate Study - Full Text View

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 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:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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

Primary Outcome Measures:

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:

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.
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.
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.
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.


Enrollment:	63
Study Start Date:	February 2010
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.

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.

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Eligibility


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

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

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

Publications:

Gross CR, Kreitzer MJ, Reilly-Spong M, Winbush NY, Schomaker EK, Thomas W. Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlist. Clin Trials. 2009 Feb;6(1):76-89. doi: 10.1177/1740774508100982.

Gross CR, Kreitzer MJ, Russas V, Treesak C, Frazier PA, Hertz MI. Mindfulness meditation to reduce symptoms after organ transplant: a pilot study. Altern Ther Health Med. 2004 May-Jun;10(3):58-66.

Kreitzer MJ, Gross CR, Ye X, Russas V, Treesak C. Longitudinal impact of mindfulness meditation on illness burden in solid-organ transplant recipients. Prog Transplant. 2005 Jun;15(2):166-72.

Kreitzer MJ, Gross CR, Waleekhachonloet OA, Reilly-Spong M, Byrd M. The brief serenity scale: a psychometric analysis of a measure of spirituality and well-being. J Holist Nurs. 2009 Mar;27(1):7-16. doi: 10.1177/0898010108327212. Epub 2009 Jan 28.

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

Reilly-Spong M, Reibel D, Pearson T, Koppa P, Gross CR. Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Contemp Clin Trials. 2015 May;42:169-84. doi: 10.1016/j.cct.2015.03.013. Epub 2015 Apr 3.


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 )
Study First Received:	September 27, 2010
Results First Received:	June 21, 2016
Last Updated:	September 13, 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

ClinicalTrials.gov processed this record on August 16, 2017