Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-01 @ 12:20 AM
Study NCT ID:
NCT02686333
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2015-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation for Depression and Anxiety Symptoms in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants screened as eligible who enroll', 'timeFrame': '34 months'}, {'measure': 'Proportion of participants who enrolled who completed the 8 week-trial', 'timeFrame': '34 months'}, {'measure': 'Tolerability of Meditation Intervention on a 10-point Likert scale', 'timeFrame': '8 weeks', 'description': 'Tolerability of intervention on a 10-point Likert scale'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline and at 8 weeks'}, {'measure': 'Change in General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline and at 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Meditation', 'Dialysis'], 'conditions': ['Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '37651553', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients currently receiving maintenance hemodialysis\n* 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)\n* Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test)\n\nExclusion Criteria:\n\n* Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)\n* Acute psychotic symptoms\n* Acute Suicidal ideation/intent'}, 'identificationModule': {'nctId': 'NCT02686333', 'briefTitle': 'Meditation for Depression and Anxiety Symptoms in Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Lady Davis Institute'}, 'officialTitle': 'Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '15-160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation Intervention 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.", 'interventionNames': ['Other: Meditation']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (No Meditation Exposure)', 'description': 'Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting.'}], 'interventions': [{'name': 'Meditation', 'type': 'OTHER', 'description': '10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises).', 'armGroupLabels': ['Meditation Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1A2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Karl Looper, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual data will be coded and anonymized. Anonymized data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Davis Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FRCPC, Chief of the Department of Psychiatry, Jewish General Hospital', 'investigatorFullName': 'Dr. Karl Looper', 'investigatorAffiliation': 'Lady Davis Institute'}}}}