Meditation for Depression and Anxiety Symptoms in Dialysis Patients

Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial

This study examines the use of brief meditation interventions for patients with symptoms of anxiety and depression who are undergoing dialysis. Half of the participants will receive meditation interventions 3 times a week, while the other half will receive treatment as usual. This study will examine whether meditation is feasible and whether it has any effect on reducing symptoms of anxiety or depression.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Other: Meditation

Detailed Description

Roughly 50% of people who undergo dialysis experience stress, anxiety or depression, but often these conditions go undetected and untreated. It is known that meditation is helpful for anxiety and depression, especially in people who have chronic health conditions. This study will look specifically at meditation interventions tailored to the dialysis setting. Patients on maintenance hemodialysis with anxiety and depression will be recruited from hemodialysis units. Recruitment will start at the Jewish General Hospital in March 2016. Recruitment may later expand to University Health Network (Toronto), and/or other sites affiliated with McGill University or University of Toronto.

Participants will then be randomly assigned to receive meditation or continue with their usual treatment. The participants assigned to the meditation group will practice several meditation techniques with a trained interventionist 3 times a week, during their dialysis sessions.

At the end of the 8 weeks, the investigators will assess whether the meditation intervention was feasible (i.e. whether recruitment goals were met and drop out rates were as expected). Participants in the meditation group will be asked to rate whether they enjoyed the meditation on a scale. Both the participants assigned to the meditation group and to the usual treatment group will be asked to rate their depression and anxiety symptoms on the PHQ-9 and the GAD-7 scales to evaluate whether there was any change.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1A2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients currently receiving maintenance hemodialysis
• Patients with depression and/or anxiety as indicated by scores of ≥10 on the Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder-7 (GAD- 7)
• Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test)

Exclusion Criteria:

• Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
• Acute psychotic symptoms
• Acute Suicidal ideation/intent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation Intervention Arm; 10-15 minute meditation practices (brief silent meditations, guided meditations, body scans, gentle arm movement exercises). Before each session, the interventionist will perform a brief check in, and may discuss the patient's experience with them for 1-2 minutes after the intervention. Patients will be encouraged to practice the techniques at home between sessions. Patients will also be offered literature on mental health promotion.	Other: Meditation; 10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises).
No Intervention: Control Group (No Meditation Exposure); Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants screened as eligible who enroll		34 months
Proportion of participants who enrolled who completed the 8 week-trial		34 months
Tolerability of Meditation Intervention on a 10-point Likert scale	Tolerability of intervention on a 10-point Likert scale	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Patient Health Questionnaire (PHQ-9)	Baseline and at 8 weeks
Change in General Anxiety Disorder-7 (GAD-7)	Baseline and at 8 weeks

Collaborators and Investigators

• Sponsor: Lady Davis Institute
• Collaborators: University Health Network, Toronto; Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Karl Looper, MD, FRCPC, Jewish General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Meditation; Dialysis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 15-160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will be coded and anonymized. Anonymized data will not be shared.