Mindfulness and HEP in Dialysis Patients With Depression and Anxiety
Condition: Renal Disease; Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This pilot clinical trial examines the acceptability of meditation techniques versus health
      promotion in people receiving dialysis who have anxiety or depression. 50% of people who
      undergo dialysis experience anxiety or depression, but these conditions go undetected and
      untreated. Meditation and help promotion is helpful for anxiety and depression, but no one
      has compared the effects of meditation versus health promotion in people on dialysis
      specifically. Our aim is to evaluate whether meditation is more effective than health
      promotion.

      Nephrology doctors and nurses from collaborating hospitals in Montreal (MUHC) will help the
      recruit participants. The study will last 8 weeks, including a 6-month follow-up to measure
      depression and anxiety symptoms. Assessment will include pre-post evaluations about their
      depression and anxiety symptoms, overall health, sleep (Acti-watch), heart rate variability
      and blood draws (for inflammatory markers). A qualitative interview assessing participant
      experience will take place at program end.

      Participants will be randomly assigned. The participants will practice meditation or health
      promotion exercises with a trained interventionist in 20-minute sessions 3 times a week,
      during their dialysis sessions. Participants in the meditation group will learn mindfulness
      meditation exercises, whereas participants in the health promotion group will learn about
      healthy diet, music, exercise and positive health-enhancing life changes.

      Many people find meditation and health promotion enjoyable and relaxing. In the unlikely
      event people may have intense, but not dangerous reactions to meditation, the
      interventionists are trained to manage their reaction and direct them to appropriate care.
      Their hemodialysis treatment will not be affected by this study.

      It is hoped to improve mental health care for people on dialysis suffering from depression
      and anxiety. If this study shows that people in the meditation group greatly benefited than
      those participating in health promotion, investigators will create a bigger study to confirm
      whether it is truly effective for anxiety and depression in dialysis patients. Meditation may
      become a widely used treatment for people on dialysis with anxiety and depression, and
      investigators would train nephrology staff to make this treatment as accessible as possible.
    

Detailed description: 
      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).

      Our findings suggested that although a chair-side mindfulness intervention is appreciated by
      dialysis patients, a number of modifications could improve impact: targeting patients with
      more significant baseline depressive or anxiety symptoms, incorporating a cognitive therapy
      component to better understand how to apply mindfulness in daily life, and finding novel ways
      to improve scalability. The next step is a pilot RCT with an active control group controlling
      for clinical attention and support to estimate the sample size of a definitive RCT.
      Investigators propose to strengthen our experimental design by addressing sustained treatment
      effects of chair-side mindfulness intervention while compared to the Health Enhancement
      Program (HEP)- a validated active control.

      Inflammatory response in dialysis patients. Patients undergoing dialysis also often have a
      high burden of systemic inflammation, including elevated blood inflammation biomarkers. This
      in turn triggers a cascade that has been extensively shown in humans and animals to cause
      depressive symptoms, due to the permeability of blood endothelial cells, followed by
      activation of inflammatory pathways in the brain (28442354) and consequently, symptoms of
      depression. A possible association between these pro-inflammatory cytokines and the symptoms
      of depression can better explain the high rates of depression and the non-adherence to
      treatment in patients undergoing dialysis. Recent evidence suggests that mind-body therapies
      decrease the levels of the inflammation biomarkers such as inflammatory transcription factor
      NFKB (nuclear factor kB), which also has been associated with lower symptoms of anxiety and
      depression. Thus, an association between these two components can better explain the high
      rates of depression, non-adherence to treatment and can be a predictor of poor antidepressant
      and psychotherapy response. Therefore, it may be of great interest to explore whether
      inflammation is a predictor of depression/anxiety response in dialysis patients and whether
      mindfulness can improve inflammation in dialysis patients.

      To circumvent the urge to improve the lives of patients with kidney disease in the near term
      and with widespread applicability, our group suggests the use of a brief chair-side
      mindfulness intervention as a compelling treatment adjunct to alleviate symptoms of
      depression and anxiety using a validated active control (HEP). This study will also
      investigate whether brief chair-side mindfulness may sustain decreased symptoms of depression
      and anxiety at 6-month follow-up, whether it may provide better perceptions of stress and
      improvement, as well as improving sleep quality, heart rate variability and inflammatory
      markers at 8-week and, which in turn may enhance response to additional adjunctive therapies
      (e.g. psychotropic medications), if necessary.
    

Intervention name(s): Chair-side mindfulness intervention
Intervention type(s): Behavioral
Intervention description(s): Tailored mindfulness intervention to chair-side type, based from Mindfulness Based Cognitive Therapy (MBCT).
Health promotion based on the Health Enhancement Program (HEP).
Other intervention name(s): HEP active control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment