Clinical trial NCT03406845: Mindfulness and HEP in Dialysis Patients With Depression and Anxiety
Official title: Brief Chair-Side Mindfulness Intervention for Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Pilot Randomized Control Trial With an Active Control Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Disease
Depression
Anxiety
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: University of Toronto
name: University of Western Ontario, Canada
First posted: 2018-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18yrs.\>
* Currently receiving maintenance hemodialysis, with depression (Patient Health Questionnaire (PHQ-9) score ≥6) and/or anxiety (General Anxiety Disorder-7 (GAD- 7) score ≥6).
* Normal cognition or Mild Cognitive Impairment will be addressed on a normal screening result on the 3-minute Mini-Cog Test (53).
* Patients should have sufficient hearing to follow verbal instructions, be able to sit for 20-25 minutes without discomfort
* Have adequate understanding of English and/or French

Exclusion Criteria:

* Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test (53))
* Acute psychotic symptoms,
* Acute suicidal ideation/intent
* Patients currently receiving active psychotherapy

Primary outcomes:
measure: Depression scores measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 8 weeks and 6 months
Secondary outcomes:
measure: Anxiety scores measured by the General Anxiety Questionnaire (GAD-7)
timeFrame: Baseline, 8 weeks and 6 months
Other outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline and 8 weeks
measure: Perceived Improvement Questionnaire (PIQ)
timeFrame: At program end (8 weeks)
measure: Athens Insomnia Scale (AIS)
timeFrame: Baseline and 8 weeks
measure: Patient's assessment on Quality of Life (EuroQOL)
timeFrame: Baseline and 8 weeks
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Baseline and 8 weeks
measure: Social Difficulties Inventory (SDI)
timeFrame: Baseline and 8 weeks
measure: Inflammatory markers (blood draw)
timeFrame: Baseline and 8 weeks
measure: Heart rate variability (HRV)
timeFrame: Baseline and 8 weeks
measure: Circadian rhythm and sleep quality
timeFrame: Baseline and 8 weeks
Locations:
city: Montréal
country: Canada
facility: Lady David Institute
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Psychiatrist and researcher
name: Soham Rej, MD/MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas Z, Novak M, Platas SGT, Gautier M, Holgin AP, Fox R, Segal M, Looper KJ, Lipman M, Selchen S, Mucsi I, Herrmann N, Rej S. Brief Mindfulness Meditation for Depression and Anxiety Symptoms in Patients Undergoing Hemodialysis: A Pilot Feasibility Study. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2008-2015. doi: 10.2215/CJN.03900417. Epub 2017 Oct 12.
citation: Rigas C, Park H, Nassim M, Su CL, Greenway K, Lipman M, McVeigh C, Novak M, Trinh E, Alam A, Suri RS, Mucsi I, Torres-Platas SG, Noble H, Sekhon H, Rej S, Lifshitz M. Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial. Can J Kidney Health Dis. 2022 Mar 4;9:20543581221074562. doi: 10.1177/20543581221074562. eCollection 2022.