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Meditation for Depression and Anxiety Symptoms in Dialysis Patients

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Meditation
Sponsored by
Lady Davis Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Meditation, Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation Intervention Arm

Control Group (No Meditation Exposure)

Arm Description

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.

Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting.

Outcomes

Primary Outcome Measures

Proportion of participants screened as eligible who enroll
Proportion of participants who enrolled who completed the 8 week-trial
Tolerability of Meditation Intervention on a 10-point Likert scale
Tolerability of intervention on a 10-point Likert scale

Secondary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9)
Change in General Anxiety Disorder-7 (GAD-7)

Full Information

First Posted
December 30, 2015
Last Updated
September 8, 2020
Sponsor
Lady Davis Institute
Collaborators
University Health Network, Toronto, Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02686333
Brief Title
Meditation for Depression and Anxiety Symptoms in Dialysis Patients
Official Title
Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
Collaborators
University Health Network, Toronto, Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Meditation, Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (No Meditation Exposure)
Arm Type
No Intervention
Arm Description
Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting.
Intervention Type
Other
Intervention Name(s)
Meditation
Intervention Description
10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises).
Primary Outcome Measure Information:
Title
Proportion of participants screened as eligible who enroll
Time Frame
34 months
Title
Proportion of participants who enrolled who completed the 8 week-trial
Time Frame
34 months
Title
Tolerability of Meditation Intervention on a 10-point Likert scale
Description
Tolerability of intervention on a 10-point Likert scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Time Frame
Baseline and at 8 weeks
Title
Change in General Anxiety Disorder-7 (GAD-7)
Time Frame
Baseline and at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Looper, MD, FRCPC
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will be coded and anonymized. Anonymized data will not be shared.

Learn more about this trial

Meditation for Depression and Anxiety Symptoms in Dialysis Patients

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