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Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00714818
First received: July 8, 2008
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

Women with a close relative who has experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of the illness, and are often very worried about the chance that any children that they have will become affected with the same illness. Often, because of this fear, these healthy women choose not to have children.

Genetic 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 women who have a first degree relative with a major mental illness.


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
 Behavioral: Genetic Counseling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • knowledge [ Time Frame: immediately post intervention and 1 month post intervention ] [ Designated as safety issue: No ]
  • risk perception [ Time Frame: immediately post intervention and 1 month post intervention ] [ Designated as safety issue: No ]
  • stigma [ Time Frame: immediately post intervention and 1 month post intervention ] [ Designated as safety issue: No ]
  • perceived control [ Time Frame: immediately post intervention and 1 month post intervention ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: August 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: Genetic Counseling
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
Active Comparator: EB
Educational Booklet: 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
 Behavioral: Genetic Counseling
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.
No Intervention: WT
Waitlist

Detailed Description:

We will recruit 75 women who have a close relative with 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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fluent in English, and
  • Have a first degree relative diagnosed with schizophrenia, bipolar, or schizoaffective disorder, and
  • Reside in BC, and be able to attend 3 study visits over 1.5 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714818

Locations
Canada, British Columbia
Centre for Complex Disorders, BC Mental Health and Addictions Reserach Institute
Vancouver, British Columbia, Canada, V5A 4H4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jehannine Austin, PhD, CCGC, CGC University of British Columbia
Study Director: Catriona Hippman University of British Columbia
Study Director: Erin Michalak University of British Columbia
Study Director: William Honer, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00714818     History of Changes
Other Study ID Numbers: H07-02706
Study First Received: July 8, 2008
Last Updated: November 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Schizophrenia
Bipolar Disorder
Schizoaffective disorder
Genetic Counseling
Risk perception
Stigma
 Control
Knowledge
family members
Sibling parent or child with schizophrenia
Sibling parent or child with bipolar disorder
Sibling parent or child with schizoaffective disorder

Additional relevant MeSH terms:
Mental Disorders
Bipolar Disorder
Psychotic Disorders
Schizophrenia
 Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 19, 2013