Journeys to Wellness: A Transplant Candidate Study
|End-stage Renal Disease||Behavioral: tMBSR Behavioral: Support group||Phase 3|
|Study Design:||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|
- 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.
|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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- Test the efficacy of a telephone-adapted Mindfulness-Based Stress Reduction (tMBSR) program to reduce symptoms and improve the quality of life of kidney transplant candidates by 8-weeks and by 6-month follow-up.
- Evaluate the impact of tMBSR on sleep measured by actigraphy, and on physiologic stress, as indicated by alteration in the slope of diurnal salivary cortisols, measured before and at the end of the 8-week active intervention period.
- Evaluate the impact of tMBSR on perceptions of transplant surgery (treatment satisfaction, pain) and of Health Related Quality of Life (HRQL) at 2-, 6- and 12-mos post-transplant surgery.
- Design a full-scale randomized controlled trial (RCT) of the effectiveness and cost-effectiveness of tMBSR.
- Primary: The tMBSR group will report better outcomes than an attention control support group (SG) on standardized scales for anxiety, depression, and sleep quality and health-related quality of life at 8 weeks and 6 month follow-up.
- Secondary: The tMBSR group will report better outcomes than the SG group on actigraphy-derived sleep parameters and diurnal salivary cortisol patterns.
- Tertiary: Candidates who attended mindfulness training will report greater treatment satisfaction, less distress from pain with transplant surgery and better HRQL 2 months, 6 months and 1 year after kidney transplantation.
Rationale for study : For patients with living with kidney failure, the wait for new kidney is a stressful time. Pharmacologic therapies for managing symptoms of stress increase risks for side effects and non-adherence. Mindfulness-based stress reduction (MBSR), a non-pharmacologic program of training in mindfulness meditation, could help these patients reduce their symptom distress without increasing these other risks.
Long-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide symptom relief to transplant patients, and are safe, practical and cost-effective.
Interventions: The tMBSR program includes the curricular content of the standard 8-week MBSR program (2002 Instructor's Manual). A trained teacher provides instruction in meditation techniques including the body-scan, standing, sitting and walking meditations, and gentle Hatha yoga. Whereas the standard MBSR is conducted as 8 weekly 2.5 hour classes with a one day retreat between weeks 6 and 7, the telephone-adapted MBSR program begins with 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. Home practice expectations are 25 minutes per day, 6 days a week for tMBSR.
The attention control consists of two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support.
- Direct mail to candidates being followed by the Transplant Information Services Office with follow-up calls; invitation letters and brochures sent from the P01 Clinical Core.
- Posters and flyers in medical clinics.
- Referral by health providers - in- service presentations to the pre-transplant coordinators who manage the kidney candidates;
- Additional invitations letters mailed by the coordinator who maintains the waitlist for the United Network for Organ Sharing (UNOS); study brochure or invitation letters mailed with waitlist acceptance letters.
Potential Measures of intervention 'dose' or enactment:
- Mindfulness scale: Mindful Awareness Attention Scale (MAAS);
- Meditation practice time.
Exploratory Outcomes: Post-transplant impact on Quality of Life (QOL) by Short-Form-36 item(SF-36), pain and satisfaction with transplant hospitalization.
- Self-report, mailed questionnaires completed at study weeks 0, 8, 26 (primary outcomes and QOL measures),
- Actigraphy recording for 1 week prior to the intervention and during the last week of the intervention; cortisol collection for 3 days during same time periods.
- Post transplant evaluations - 2 and 6 mos; 1 year coordinated with Transplant Database
Duration of Treatment: 8 weeks
Study Duration: Participants are followed up to one year post-kidney transplant.
Statistical Considerations: This study is powered to compare MBSR and SG, on the primary endpoint, on the State Trait Anxiety Inventory (STAI), at 8 weeks. Randomization may be stratified by dialysis (yes/no) and history of diabetes (yes/no).
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|