DepressionPhase 3NCT02686333
Meditation for Depression and Anxiety Symptoms in Dialysis Patients
A Phase 3 study testing Meditation in people with Depression and Anxiety, run by Lady Davis Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
- Acute psychotic symptoms
- Acute Suicidal ideation/intent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Meditation
- Keywords
- Meditation, Dialysis
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises).
| Study group | Role | What they receive |
|---|---|---|
| Meditation Intervention Arm | Experimental | 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. Receives: Other: Meditation |
| Control Group (No Meditation Exposure) | No intervention | Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants screened as eligible who enroll
Measured: 34 months
Proportion of participants who enrolled who completed the 8 week-trial
Measured: 34 months
Tolerability of Meditation Intervention on a 10-point Likert scale
Tolerability of intervention on a 10-point Likert scale
Measured: 8 weeks
Secondary outcomes (2)
Change in Patient Health Questionnaire (PHQ-9)
Measured: Baseline and at 8 weeks
Change in General Anxiety Disorder-7 (GAD-7)
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion1 Dec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karl Looper, Lady Davis Institute
- Investigators
- Karl Looper, MD, FRCPC, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686333
- Sponsor's protocol ID
- 15-160
- Status last verified
- Sep 2020
- First submitted
- 30 Dec 2015
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual data will be coded and anonymized. Anonymized data will not be shared.
Publications
Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
PubMed 37651553
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02686333
- Acronym / sponsor ID
- 15-160
- Conditions
- Depression, Anxiety
- Keywords
- Meditation, Dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre
- Study start
- Mar 2016
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Intervention Arm | Experimental | Other: Meditation10-15 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. |
| Control Group (No Meditation Exposure) | No intervention | –Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
- Acute psychotic symptoms
- Acute Suicidal ideation/intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises). | Other | Meditation Intervention Arm |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Derived from this study: PubMed 37651553Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
- Individual participant dataSharing planned: No. Individual data will be coded and anonymized. Anonymized data will not be shared.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Looper, MD, FRCPC principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meditation in people with Depression and Anxiety, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants screened as eligible who enroll (time frame: 34 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.