Brief Chair-Side Mindfulness Intervention for Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Pilot Randomized Control Trial With an Active Control Group

Background Dialysis patients are prone to lower increased non-adherence, suicidal behavior, medical comorbidity, mortality and low quality of life. As a result of illness burden in dialysis, treatment is costly and resources for treatment allocation are on the rise. In the United States alone, costs per year of dialysis are US$67,000 for Medicare patients and US$80,000 for employer group health plan patients, and the worldwide consensus on estimates for total therapy cost in dialysis indicate that hospital dialysis is more expensive that non-hospital dialysis. Moreover, depression and anxiety are highly costly to health systems and society, and are the most common mental health symptoms in patients on maintenance dialysis (e.g. 50% of patients experience depression and anxiety symptoms) as supported by our recent cross-sectional study of 80 dialysis patients in Toronto and Montreal. Additionally, estimates of depression and anxiety diagnoses based on psychiatric interview in patients in dialysis vary between 20% and 30%, classifying depression as most common in patients on dialysis compared to the regular population.

Patients' views on dialysis treatment: treatment adherence and health outcomes. Limited studies investigating dialysis views convey barriers to adherence to pharmacological treatment, including doubts about the effectiveness of medications, complicated healthcare systems, and financial difficulties. This is significant, given patients need to have a sense of control, demonstrate self-efficacy and trust the advice from health care providers for shared decision-making and to maintain quality of life. Moreover, special attention has been paid to the study of patient perspectives in depression and anxiety, especially as important barriers to treatment retention include symptomatology display. In dialysis patients, depression plays an important role in adherence of treatment as patient report insufficient counselling and support during treatment; the high proportion of multiple disabilities experienced during treatment inevitably decreases patient's quality of life and augments outcomes related to poor health (e.g. insomnia). It is therefore important to study illness and health perceptions on treatment outcome as these may not only serve to improve adherence of dialysis treatment, but other health outcomes.

Limitations of existing treatments for depression and anxiety in dialysis patients. Given that depression and anxiety are associated with lower quality of life, disability, mortality, increased hospitalizations, shortened survival, increased dialysis non-adherence and suicidal behavior, dialysis patients' themselves have identified depression and anxiety as priorities for treatment and research. Existing health service delivery approaches, such as use of psychotropic medication and psychotherapy have been inadequate, resource-intensive, and are not financially feasible. First, there is often little interest from users and providers to modify or use antidepressant treatment as an effort to improve depression management. Current reports reiterating the issue of recruitment to antidepressant trials have identified concerns to pill burden (e.g. antidepressant dependency and increased side-effects), large dropout rates and low adherence to medication. Second, the role of competing factors (e.g. high symptom burden, inter-current events, and kidney disease-related losses) challenge the interpretation of results from trials conducted to depression treatment in dialysis and non prioritizing its treatment. Third, time requirements of dialysis treatment, patient tiredness before and after treatment, are impractical to patients' compliance to participate in psychosocial interventions. Also, there is no clear evidence to use Cognitive Behavioral Therapy (CBT) as a mean to alleviate symptoms of depression. This is of particular concern in the attempt to implement feasible and sustainable interventions in clinical practice, given the small number of studies reporting patient consent rates and uptake to these types of interventions.

Mindfulness-based interventions for dialysis patients. New "third" wave therapies including mindfulness-based interventions have gained increasing popularity in recent years as approaches to reduce psychological morbidity and emotional distress in physical and mental illness. Mindfulness involves learning concentration and relaxation techniques that allow practitioners to enter into present-moment awareness where the mind is simultaneously focused and relaxed. Such relaxed, yet focused mental states can help with depression and anxiety by teaching patients to be in the present moment, reducing the impact of negative cognitions and self-judgemental thoughts that often occur in anxiety and depression. Mindfulness-based Cognitive Therapy (MBCT) has been highly effective in treating chronic physical illness and many other conditions, including cancer. To our knowledge, literature reports on mindfulness for the treatment of depression hemodialysis are very limited. Some researchers have examined the effect of mindfulness-based psychotherapy and acceptance and commitment therapy on dialysis patients, but our group has been the first to explore the feasibility of brief chair-side mindfulness meditation for depression and anxiety symptoms in patients undergoing dialysis.

Preliminary results- Brief mindfulness intervention for patients undergoing hemodialysis. This group of researchers have completed a pilot randomized controlled trial (RCT) comparing brief mindfulness meditation (n=21) to treatment-as-usual (n=30), where the intervention was found feasible and enjoyable for patients on dialysis despite several systemic barriers. Of the participants randomized to the intervention group, 71% completed the study, with meditation being well-tolerated (median rating of 8/10 in Likert scale). Meditation was associated with subjective benefits but no significant impact on depression scores (change in PHQ9 -3.00±3.93 in the intervention group vs. - 2.00±4.74 in controls, p=0.45) or anxiety scores (change in GAD-7 -0.94±4.59 vs. -0.80±4.84, p=0.91). In this pilot sample, the intervention did not have statistically significant effects on depression and anxiety symptoms, except in a subgroup with more impairing baseline symptom, where it was beneficial (clinically important reduction in depressive symptom scores -4.29±3.5 vs. +0.14±3.5, p=0.034, n=14, 34% of sample).