Journeys to Wellness: A Transplant Candidate Study
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.
End-stage Renal Disease
Behavioral: Support group
|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|
- State-Trait Anxiety Inventory [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]self-reported anxiety symptoms
- 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
|Study Start Date:||February 2010|
|Study Completion Date:||August 2015|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01254214
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Cynthia R Gross, PhD||University of Minnesota - Clinical and Translational Science Institute|