Meditation for Depression and Anxiety Symptoms in Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT02686333|
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : September 10, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety||Other: Meditation||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||December 1, 2017|
|Actual Study Completion Date :||December 2017|
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.
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.
- Proportion of participants screened as eligible who enroll [ Time Frame: 34 months ]
- Proportion of participants who enrolled who completed the 8 week-trial [ Time Frame: 34 months ]
- Tolerability of Meditation Intervention on a 10-point Likert scale [ Time Frame: 8 weeks ]Tolerability of intervention on a 10-point Likert scale
- Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline and at 8 weeks ]
- Change in General Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline and at 8 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
- Acute psychotic symptoms
- Acute Suicidal ideation/intent
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
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1A2|
|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|
|Other Study ID Numbers:||
|First Posted:||February 19, 2016 Key Record Dates|
|Last Update Posted:||September 10, 2020|
|Last Verified:||September 2020|
|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.|