Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation
Contemporary clinical trials
Short Title:
Contemp.Clin.Trials
Format:
Journal Article
Publication Date:
Nov 30, 2016
Pages:
37 - 43
Sources ID:
44886
Notes:
LR: 20180601; CI: Copyright (c) 2017; ClinicalTrials.gov/NCT01254214; GR: P01 DK013083/DK/NIDDK NIH HHS/United States; GR: UL1 TR000114/TR/NCATS NIH HHS/United States; JID: 101242342; NIHMS868805; OTO: NOTNLM; 2016/12/15 00:00 [received]; 2017/03/07 00:00 [revised]; 2017/03/21 00:00 [accepted]; 2017/03/28 06:00 [pubmed]; 2018/03/08 06:00 [medline]; 2017/03/27 06:00 [entrez]; ppublish
Visibility:
Private
Abstract:
(Show)
BACKGROUND: Patients with progressive kidney disease experience increasing physiologic and psychosocial stressors and declining health-related quality of life (HRQOL). METHODS: We conducted a randomized, active-controlled, open-label trial to test whether a Mindfulness-based Stress Reduction (MBSR) program delivered in a novel workshop-teleconference format would reduce symptoms and improve HRQOL in patients awaiting kidney transplantation. Sixty-three transplant candidates were randomized to one of two arms: i) telephone-adapted MBSR (tMBSR, an 8-week program of meditation and yoga); or ii) a telephone-based support group (tSupport). Participants completed self-report questionnaires at baseline, post-intervention, and after 6-months. Anxiety, measured by the State-Trait Anxiety Inventory (STAI) post-intervention served as the primary outcome. Secondary outcomes included: depression, sleep quality, pain, fatigue, and HRQOL assessed by SF-12 Physical and Mental Component Summaries (PCS, MCS). RESULTS: 55 patients (age 54+/-12yrs) attended their assigned program (tMBSR, n=27; tSupport, n=28). 49% of patients had elevated anxiety at baseline. Changes in anxiety were small and did not differ by treatment group post-intervention or at follow-up. However, tMBSR significantly improved mental HRQOL at follow-up: +6.2 points on the MCS - twice the minimum clinically important difference (95% CI: 1.66 to 10.8, P=0.01). A large percentage of tMBSR participants (>/=90%) practiced mindfulness and reported it helpful for stress management. CONCLUSIONS: Neither mindfulness training nor a support group resulted in clinically meaningful reductions in anxiety. In contrast, finding that tMBSR was more effective than tSupport for bolstering mental HRQOL during the wait for a kidney transplant is encouraging and warrants further investigation. ClinicalTrials.govNCT01254214.