Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT00474357
Status:
UNKNOWN
Last Update Posted:
2010-12-17
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-16', 'studyFirstSubmitDate': '2007-05-15', 'studyFirstSubmitQcDate': '2007-05-15', 'lastUpdatePostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accepting Mental Illness Scale', 'timeFrame': '7 weeks'}], 'secondaryOutcomes': [{'measure': 'Hope Scale', 'timeFrame': '7 weeks'}, {'measure': 'Myths about BAD questionnaire', 'timeFrame': '7 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bipolar affective disorder', 'myths', 'preconceived notions', 'stigma', 'hope'], 'conditions': ['Bipolar Affective Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lev-hasharon.co.il', 'label': 'Lev-Hasharon Mental Health Center'}]}, 'descriptionModule': {'briefSummary': 'This study will examine:\n\n1\\) The impact of psycho education group therapy sessions relating to beliefs/myths associated with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and cognition of individuals diagnosed with BAD 2) Will examine the existence of those same beliefs among the various caregivers - psychiatrists, general practitioners, social workers, and psychiatric nurses.\n\nThe investigators hypothesize that psychoeducation group therapy will be effective in refuting the myths and will lead to better treatment adherence, longer remissions, fewer hospitalizations, improved self esteem, increased optimism, and better control over the disease process. The investigators also believe that they will identify some beliefs/myths or preconceived notions that are common to both caregivers and individuals with BAD.', 'detailedDescription': 'Methods:\n\nEffect psychoeducation:\n\nStudy population - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and will then participate in 7 weekly sessions of brief structured psycho education therapy Control group - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale. In addition both groups will complete the Snyder Hope Scale, Accepting the Mental Illness Label Scale and a questionnaire regarding Myths in BAD prior to the study, and when the study group finishes their group therapy sessions. (Controls will not participate in the psychoeducation group therapy).\n\nCaregivers beliefs:\n\n50 caregivers from various professions will complete the questionnaire regarding the myths, once only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of BAD\n* State of remission\n\nExclusion Criteria:\n\n* HAM-D score \\< 10\n* YMRS score \\< 12\n* Has a guardian for either self or property'}, 'identificationModule': {'nctId': 'NCT00474357', 'acronym': 'BAD', 'briefTitle': 'Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lev-Hasharon Mental Healtlh Center'}, 'officialTitle': 'Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy', 'orgStudyIdInfo': {'id': 'LH55/2007.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bipolar patients participating in psychoeducation intervention', 'interventionNames': ['Behavioral: Brief Structured Psychoeducation Group Therapy']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'bipolar patients who do not participate in psychoeducation group'}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Therapists will complete questionnaires regarding myths about bipolar patients, no intervention'}], 'interventions': [{'name': 'Brief Structured Psychoeducation Group Therapy', 'type': 'BEHAVIORAL', 'description': 'weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Deby Peres, MD', 'role': 'CONTACT', 'email': 'debyp@lev-hasharon.co.il', 'phone': '+972-9-8981242', 'phoneExt': '242'}, {'name': 'Igor Oyffe, MD', 'role': 'CONTACT', 'email': 'igoro@lev-hasharon.co.il', 'phone': '+972-9-8981248', 'phoneExt': '248'}, {'name': 'Deby Peres, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Igor Oyffe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amit Levin, MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Azikri, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lev Hasharon Mental Health Center', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Deby Peres, MD', 'role': 'CONTACT', 'email': 'debyp@lev-hasharon.co.il', 'phone': '+972-9-8981242', 'phoneExt': '242'}, {'name': 'Igor Oyffe, MD', 'role': 'CONTACT', 'email': 'igoro@lev-hasharon.co.il', 'phone': '+972-9-8981248', 'phoneExt': '248'}], 'overallOfficials': [{'name': 'Igor Oyffe, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lev HaSharon Mental Health Center'}, {'name': 'Deby Peres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lev HaSharon Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lev-Hasharon Mental Healtlh Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Deby Peres', 'oldOrganization': 'Lev Hasharon Mental Health Center'}}}}