Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-06 @ 12:56 AM
Study NCT ID:
NCT00867802
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2008-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness Intervention For Child Abuse Survivors (MICAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2008-12-08', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Trauma Symptom Inventory to all participants at each visit. Administer the Beck Depression Inventory (BDI) to all participants. Functional Assessment of Chronic Illness Therapy spiritual Well-Being (FACIT-SP)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MICAS', 'MBSR'], 'conditions': ['Child Abuse Survivors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse.', 'detailedDescription': 'The specific aims of the project are:\n\n1. To determine whether Mindfulness- Based Stress Reduction program is associated with a reduction in symptoms of depression, anxiety, and psychological distress.\n2. To assess indications of efficacy, assess feasibility of enrollment and compliance among this patient population\n3. Provide pilot data that can be used to apply for larger grants to more fully develop this approach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A history of child abuse, as attested by the potential participant\n* Currently in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker).\n* Plans to remain in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker) for the duration of the study.\n* Recommendation made by the potential participant's licensed psychotherapist (psychiatrist, psychologist, social worker) the Mindfulness-Based Stress Reduction program would be an appropriate adjunct therapy for his or her client.\n* Score of 0.50 or higher on the General Severity Index of the Brief Symptom Inventory, indicating psychological distress above the normal population.\n* Aged 21 or above.\n* Ability to read and write English.\n* Able to attend 10 courses and assessment visits over a 6-week period.\n* Willing to practice skills for 20-30 minutes per day 6 days a week, during the course.\n\nExclusion Criteria:\n\n* Major psychiatric illness (bipolar disorder, schizophrenia, dissociative identity disorder, or others).\n* Active alcoholism or drug dependency.\n* Any psychological or physical illness the investigator feels would prohibit full participation in the course.\n* Currently enrolled in another clinical trial."}, 'identificationModule': {'nctId': 'NCT00867802', 'acronym': 'MICAS', 'briefTitle': 'Mindfulness Intervention For Child Abuse Survivors (MICAS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Mindfulness Intervention For Child Abuse Survivors', 'orgStudyIdInfo': {'id': 'HP-00041191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness- Based Stress Reduction: Active Comparator', 'description': 'Mindfulness-Based Stress Reduction program', 'interventionNames': ['Behavioral: Mindfulness-Based Stress Reduction program']}], 'interventions': [{'name': 'Mindfulness-Based Stress Reduction program', 'type': 'BEHAVIORAL', 'description': 'Mindfulness- Based Stress Reduction comprising of 8 classes and a one-day retreat, taught over a period of 6 weeks. Intervention also includes practice at home for 20-30 minutes.', 'armGroupLabels': ['Mindfulness- Based Stress Reduction: Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21207', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kernan Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Elizabeth Pradhan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research Center for Integrative Medicine, University of Maryland', 'investigatorFullName': 'Brian Berman', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}