This randomized, controlled trial demonstrates that MBSR reduces distressing symptoms and improves mental health and vitality in solid organ transplant recipients. Compared to the waitlist, patients randomized to MBSR reported fewer depression symptoms, better sleep quality, and increased vitality and mental health post-intervention. Compared to active controls, patients randomized to MBSR reported less anxiety, better sleep quality, and more vitality at 1 year follow-up. Medium treatment effects, based on intention-to-treat analyses, were comparable to published meta-analyses of the health impacts of mindfulness training in other clinical populations, based mainly on waitlist-controlled trials.22, 40
Durability of MBSR impact was notable. Anxiety, depression, sleep quality, mental health, vitality, health and quality of life outcomes remained significantly improved from baseline levels at 1 year within the MBSR arm. In the active control arm the scope of benefit was narrower, and impacts were less durable. Because benefits were obtained with no evidence of adverse events, these findings suggest that clinicians should consider recommending MBSR to transplant recipients who are bothered by these symptoms, particularly anxiety or poor sleep. We speculate that MBSR may also benefit patients managing other chronic conditions with complex medication regimens.
This is the first randomized controlled trial of MBSR in transplant recipients. Benefits from a non-pharmacologic intervention are particularly important for this chronically ill population dependent on lifelong immune-suppression because 40–50% of transplant recipients report elevated anxiety and depression symptoms and reduced quality of life during the first few years after transplantation.5–7
Corticosteriods, a key component of many immune suppressive regimens, may worsen anxiety and depression symptoms, while neuropathies and osteoporosis, conditions common among transplant recipients, may cause or exacerbate sleep problems. Depressed mood, anxiety and sleep problems are risk factors for morbidity, noncompliance, and mortality.41–42
This is the first controlled trial to find that a standard MBSR program provides specific and sustained benefits to sleep. Reduced arousal and interruption of sleep-incompatible cognitions such as worries and rumination have been proposed to account for the impact of MBSR on sleep.43
Comments written in study questionnaires illustrated how patients used their MBSR training to deal with poor sleep and other stressors: “I am using the body scan at bedtime. It is hectic to go to sleep with a bipap, however the body scan helps.”; “This class has provided me with several ways of coping with my severe itching”, “I can sleep better because I can use the breathing to help me get to sleep.”
Participants also commented on mindfulness helping them deal with side effects and stressful situations: “I tend to turn to mindfulness thinking when I’m having severe side effects.”; “I have learned to find peace & quiet in places I never thought [possible].”
Reasons for lack of improvement in physical health reports or pain symptom perceptions are unclear, but not wholly unexpected. The impairments to physical health experienced by transplant recipients include conditions such as amputations due to diabetes or fractures due to osteoporosis. These conditions limit the capacity for improvement on objective items assessing physical function (i.e., climbing stairs) that are heavily weighted in the physical health summary. In this context, the vitality results which are based on questions about feeling full of life and energy as opposed to feeling tired and worn out are particularly encouraging.
This was an unblinded trial, and the primary outcomes were self-reports. These limitations reflect the nature of the interventions and symptom outcomes. Other limitations were attrition and missing evaluations. These problems were evenly distributed across the interventions, however, suggesting participants did not prefer one program over the other, or have differing expectations of benefit. We have some confidence that our trial attracted a representative sample of transplant recipients. There were few exclusion criteria, and more than half of those who inquired about the study were enrolled. Consistent with transplant demographics, our trial included more men than women. Methodological concerns raised in recent reviews of MBSR, including format variations, and lack of active controls were addressed. 44–46
Based on findings reported in this trial, health care providers should consider recommending that solid organ transplant recipients who are in stable health and receiving regular medical care consider enrolling in a standard MBSR program. The MBSR program appears to be particularly beneficial to those with poor sleep quality and anxiety. It would be prudent to regularly screen all transplant recipients for treatable sleep disorders such as obstructive sleep apnea and restless legs syndrome, and evaluate recipients for clinical depression or anxiety disorders, to ensure appropriate therapies are instituted, in addition to recommending this complementary therapy for self-management.