Mindfulness-based stress reduction for solid organ transplant recipients: a randomized controlled trial

Abstract

Context: Patients who have received solid organ transplants continue to experience a myriad of complex symptoms related to their underlying disease and to chronic immunosuppression that reduce the quality of life. Beneficial nonpharmacologic therapies to address these symptoms have not been established in the transplant population.

Objective: Assess the efficacy of mindfulness-based stress reduction (MBSR) in reducing symptoms of anxiety, depression, and poor sleep in transplant patients.

Design, setting, and patients: Controlled trial with a two-staged randomization. Recipients of kidney, kidney/pancreas, liver, heart, or lung transplants were randomized to MBSR (n=72) or health education (n=66) initially or after serving in a waitlist. Mean age was 54 years (range 21-75); 55% were men, and 91% were white.

Interventions: MBSR, a mindfulness meditation training program consisting of eight weekly 2.5-hour classes; health education, a peer-led active control.

Primary outcome measures: Anxiety (State-Trait Anxiety Inventory), depression (Center for Epidemiologic Studies Depression Scale), and sleep quality (Pittsburgh Sleep Quality Index) scales assessed by self-report at baseline, 8 weeks, 6 months, and 1 year.

Results: Benefits of MBSR were above and beyond those afforded by the active control. MBSR reduced anxiety and sleep symptoms (P < .02), with medium treatment effects (.51 and .56) at 1 year compared to health education in intention-to-treat analyses. Within the MBSR group, anxiety, depression, and sleep symptoms decreased and quality-of-life measures improved by 8 weeks (P < .01, all), and benefits were retained at 1 year (P < .05, all). Initial symptom reductions in the health education group were smaller and not sustained. Comparisons to the waitlist confirmed the impact of MBSR on both symptoms and quality of life, whereas health education improvements were limited to quality-of-life ratings.

Conclusions: MBSR reduced distressing symptoms of anxiety, depression, and poor sleep and improved quality of life. Benefits were sustained over 1 year. A health education program provided fewer benefits, and effects were not as durable. MBSR is a relatively inexpensive, safe, and effective community-based intervention.

Trial registration: ClinicalTrials.gov NCT00367809.

Figures

Figure 1

Study participation and follow-up.

Figure 2

Trajectory of symptoms over time. Figure 2a. Anxiety symptoms over time in MBSR and Health Education groups. Figure 2b. Depression symptoms over time in MBSR and Health Education groups. Figure 2c. Sleep symptoms over time in MBSR and Health Education groups Means (± SE) over time for STAI (anxiety), CESD (depression) and PSQI (sleep) scales are plotted for the MBSR and Health Education (HE) groups in the intention-to-treat sample after Randomization 2, without imputation of missing values (MBSR, n=63; HE, N=59). Asterisks indicate significant between group differences: the MBSR group reported fewer symptoms of poor sleep and anxiety over time (Ps=0.02, both) than the Health Education group. The difference between groups in depression trajectories was not significant (P=0.10). Values were calculated using linear mixed models with adjustments for baseline value, course cycle, randomization strata, prior waitlist service, interaction between time and treatment impact, and intra-correlations among repeated measurements within subjects and among subjects within a course cycle.

Figure 3

Treatment effects versus the Waitlist Figure 3a. Treatment effects for MBSR group versus the Waitlist. Figure 3b. Treatment effects for Health Education versus the Waitlist. Effect sizes at 8 weeks from generalized linear models with adjustments for baseline values and randomization strata in the intention-to-treat sample after Randomization 1, without imputation of missing values (MBSR, n = 47; Waitlist, n = 29; and Health Education, n=41). Effects significantly different from 0 are indicated by an asterisk. The Physical Health Summary and SF-36 Pain subscale had small non-significant treatment effects (