Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT00713804
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2008-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Genetic Counseling for Individuals With Mental Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005817', 'term': 'Genetic Counseling'}], 'ancestors': [{'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2008-07-07', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge, risk perception, stigma, perceived control', 'timeFrame': 'immediately post intervention and 1 month post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Bipolar Disorder', 'Schizoaffective disorder', 'Genetic Counseling', 'Risk perception', 'Stigma', 'Control', 'Knowledge'], 'conditions': ['Schizophrenia', 'Bipolar Disorder', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '26930535', 'type': 'DERIVED', 'citation': 'Hippman C, Ringrose A, Inglis A, Cheek J, Albert AY, Remick R, Honer WG, Austin JC. A pilot randomized clinical trial evaluating the impact of genetic counseling for serious mental illnesses. J Clin Psychiatry. 2016 Feb;77(2):e190-8. doi: 10.4088/JCP.14m09710.'}]}, 'descriptionModule': {'briefSummary': 'People who have experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of their illness, and that they are often very worried about how the illness affects their families. In particular, affected individuals worry that there is a high chance that any children that they have will become affected with the same illness. Often, because of this fear, affected individuals choose not to have children.\n\nGenetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. This study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst individuals who have a major mental illness.', 'detailedDescription': 'We will recruit 120 individuals who have a personal history of a major psychiatric disorder (as defined above). Each participant will be randomized into one of 3 groups of approximately equal size: one of which will receive genetic counseling within 1 month after enrollment (GC), another will receive the educational brochure within 1 month (EB), and the last will be assigned to waitlist (WT). After randomization (but prior to intervention for GC and EB groups, and within 1 month after enrollment for the WT group) we will gather baseline information regarding the 4 outcome measures (perceived risk and control, stigma, and knowledge). We will re-assess the 4 outcome measures immediately post-intervention for GC and EB groups. A further follow-up (for all groups) will be conducted two months after enrollment (which is 1 month post intervention for GC and EB groups).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in English\n* Have been diagnosed with schizophrenia, bipolar, or schizoaffective disorder\n* Reside in BC, and be able to attend 3 study visits over 1.5 months'}, 'identificationModule': {'nctId': 'NCT00713804', 'briefTitle': 'Impact of Genetic Counseling for Individuals With Mental Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.', 'orgStudyIdInfo': {'id': 'H07-02427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GC', 'description': 'Genetic counseling (GC): One face-to-face genetic counseling session of 1-2hours duration, with a board certified or board eligible genetic counselor which will involve, documentation of a detailed family history, discussion of: the contributors to mental illness pathogenesis, illness risk reduction strategies, chances for family members to develop mental illness (if required), supportive counseling around living with illness/risk of illness/managing illness vulnerability, and referral to support organizations as required.', 'interventionNames': ['Behavioral: Genetic Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EB', 'description': 'Educational Booklet (EB): One educational booklet that provides information about the causes of mental illnesses, and the chances for relatives of affected individuals to develop mental illness will be provided to participants.', 'interventionNames': ['Behavioral: Educational Booklet']}, {'type': 'NO_INTERVENTION', 'label': 'WT', 'description': 'Waitlist (WT)'}], 'interventions': [{'name': 'Genetic Counseling', 'type': 'BEHAVIORAL', 'description': 'One face-to-face genetic counseling session of 1-2hours duration, with a board certified or board eligible genetic counselor which will involve, documentation of a detailed family history, discussion of: the contributors to mental illness pathogenesis, illness risk reduction strategies, chances for family members to develop mental illness (if required), supportive counseling around living with illness/risk of illness/managing illness vulnerability, and referral to support organizations as required.', 'armGroupLabels': ['GC']}, {'name': 'Educational Booklet', 'type': 'BEHAVIORAL', 'description': 'One educational booklet that provides information about the causes of mental illnesses, and the chances for relatives of affected individuals to develop mental illness will be provided to participants.', 'armGroupLabels': ['EB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4H4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Centre for Complex Disorders, BC Mental Health and Addictions Research Institute', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Jehannine Austin, PhD, CCGC, CGC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Erin Michalak', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'William Honer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Catriona Hippman, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}