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Meditation for Depression and Anxiety Symptoms in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT02686333
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : June 12, 2017
Sponsor:
Collaborators:
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. Karl Looper, Lady Davis Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Other: Meditation Phase 3

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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial
Study Start Date : March 2016
Actual Primary Completion Date : February 1, 2017
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



Primary Outcome Measures :
  1. Proportion of participants screened as eligible who enroll [ Time Frame: 34 months ]
  2. Proportion of participants who enrolled who completed the 8 week-trial [ Time Frame: 34 months ]
  3. Tolerability of Meditation Intervention on a 10-point Likert scale [ Time Frame: 8 weeks ]
    Tolerability of intervention on a 10-point Likert scale


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline and at 8 weeks ]
  2. Change in General Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline and at 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686333


Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1A2
Sponsors and Collaborators
Lady Davis Institute
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Karl Looper, MD, FRCPC Jewish General Hospital

Responsible Party: Dr. Karl Looper, MD, FRCPC, Chief of the Department of Psychiatry, Jewish General Hospital, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT02686333     History of Changes
Other Study ID Numbers: 15-160
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will be coded and anonymized. Anonymized data will not be shared.

Keywords provided by Dr. Karl Looper, Lady Davis Institute:
Meditation
Dialysis

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders