Journeys to Wellness: A Transplant Candidate Study
|ClinicalTrials.gov Identifier: NCT01254214|
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease||Behavioral: tMBSR Behavioral: Support group||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|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|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|