Mindfulness and HEP in Dialysis Patients With Depression and Anxiety

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.

Conditions

• Renal Disease
• Depression
• Anxiety

Interventions

BEHAVIORAL

Chair-side mindfulness intervention

Tailored mindfulness intervention to chair-side type, based from Mindfulness Based Cognitive Therapy (MBCT). Health promotion based on the Health Enhancement Program (HEP).

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Western Ontario, Canada

  collaborator OTHER

• Lady Davis Institute

  lead OTHER

Principal Investigators

• Soham Rej, MD/MSc · Psychiatrist and researcher

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-10

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• Canada

Study Locations