Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT01035294
Status:
COMPLETED
Last Update Posted:
2012-01-30
First Post:
2009-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-25', 'studyFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study feasibility', 'timeFrame': 'post-intervention (9 weeks after enrollment)'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression (HAD) anxiety scores', 'timeFrame': 'baseline and post-intervention (9 weeks)'}, {'measure': 'Five Factors of Mindfulness scores (FFM)', 'timeFrame': 'baseline and post-intervention (9 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anxiety Disorder in Conditions Classified Elsewhere']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness-based behavioral intervention combining breathing and other relaxation exercises on symptoms of anxiety in patients undergoing the implantation of an implantable cardioverter defibrillator. This study will pilot test the feasibility and preliminary efficacy of a mindfulness-based intervention intended to improve mindfulness and anxiety levels in ICD (Implantable Cardioverter Defibrillators) patients. A randomized controlled study design will be used, in which an 8 session phone-delivered mindfulness intervention will be compared to a usual care condition among consecutive candidates for ICD procedures. The study will be conducted at the Electrophysiology (EPS) Unit at the UMass Memorial Medical Center. Assessments will be performed at baseline and at the end of the intervention (9 weeks after enrollment).', 'detailedDescription': 'The Specific Aims of this pilot study are:\n\nPrimary aim:\n\nTo determine the feasibility of a randomized clinical trial of a phone-administered, mindfulness-based training program, as measured by recruitment and retention rates, treatment adherence and fidelity.\n\nSecondary aims:\n\n1. To obtain preliminary estimates of the effect of a phone delivered mindfulness-based intervention on mindfulness levels, measured as the difference between baseline and post-intervention Five Factors of Mindfulness scores (FFM) in the intervention and in the control group at the end of the intervention. Hypothesis: Mindfulness levels will improve in the intervention group compared to the control group.\n2. To obtain preliminary estimates of the effect of a phone delivered, mindfulness-based intervention on anxiety, measured as the difference between baseline and post-intervention Hospital Anxiety and Depression (HAD) anxiety scores in the intervention and in the control group at the end of the intervention. Hypothesis: Anxiety levels will be reduced in the intervention group, compared to the control group.\n3. To collect preliminary data about the number of arrhythmic episodes/administered shocks during the intervention period. Hypothesis: the proportion of patients experiencing arrhythmic events/shocks will decrease in the intervention vs. the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 21\n2. ICD procedure\n3. Ability to understand and speak English\n4. Access to a telephone\n\nExclusion Criteria:\n\n1. Inability or unwillingness to give informed consent\n2. Signs of cognitive impairment (Blessed Orientation-Memory-Concentration (BOMS)scores \\>10)\n3. New York Heart Association (NYHA) functional class\\>III, angina Canadian Cardiovascular Society(CCS) III and IV or clinically unstable\n4. Awaiting coronary by-pass or heart transplantation\n5. Co-morbid life threatening condition\n6. Ongoing severe depression or psychosis'}, 'identificationModule': {'nctId': 'NCT01035294', 'briefTitle': 'A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'A Mindfulness-based Intervention for Treatment of Anxiety in ICD Patients', 'orgStudyIdInfo': {'id': 'H-13078'}, 'secondaryIdInfos': [{'id': '1F32AT005048-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1F32AT005048-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mindfulness based intervention', 'interventionNames': ['Behavioral: mindfulness based intervention (MBI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care (UC)', 'interventionNames': ['Behavioral: usual care']}], 'interventions': [{'name': 'mindfulness based intervention (MBI)', 'type': 'BEHAVIORAL', 'description': 'Eight, phone delivered, individual mindfulness sessions. Each training session will last 30 minutes (20 minutes for intervention + an additional 10 minutes for questions, answers, and for scheduling the next intervention. Patients will also receive instructions to practice at home every day, at least once a day, for at least 15 minutes. An audio CD containing guided mindfulness exercises will be given to the patient at the beginning of the study, to guide them during their home practice. The CD consists of sequences of different mindfulness techniques, consistent with the techniques learned during each session with the instructor. Each patient will record the minutes of mindfulness practice in a diary to be kept daily.', 'armGroupLabels': ['mindfulness based intervention']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'description': 'The UC group will be offered the standard care planned by the hospital, which includes the routine care provided by the electrophysiology team and other health care professionals that the patient may see over the course of the ICD experience. All patients receive a number of printed education materials and participate to support meetings for ICD patients four times a year. Being part of the standard care offered at UMass Memorial Medical Center, these meetings are offered to all patients regardless of their assignment (thus including patients assigned to the MBI arm).', 'armGroupLabels': ['usual care (UC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Elena Salmoirago-Blotcher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elena Salmoirago-Blotcher', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}