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Impact of Genetic Counseling for Individuals With Mental Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713804
First Posted: July 11, 2008
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  Purpose

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.

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 individuals who have a major mental illness.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Knowledge, risk perception, stigma, perceived control [ Time Frame: immediately post intervention and 1 month post intervention ]

Enrollment: 120
Study Start Date: July 2008
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GC
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.
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 (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.
Behavioral: 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.
No Intervention: WT
Waitlist (WT)

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fluent in English
  • Have been diagnosed with schizophrenia, bipolar, or schizoaffective disorder
  • Reside in BC, and be able to attend 3 study visits over 1.5 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713804


Locations
Canada, British Columbia
Centre for Complex Disorders, BC Mental Health and Addictions Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jehannine Austin, PhD, CCGC, CGC University of British Columbia
Study Director: Erin Michalak University of British Columbia
Study Director: William Honer, MD University of British Columbia
Study Director: Catriona Hippman, MSc University of British Columbia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00713804     History of Changes
Other Study ID Numbers: H07-02427
First Submitted: July 7, 2008
First Posted: July 11, 2008
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by University of British Columbia:
Schizophrenia
Bipolar Disorder
Schizoaffective disorder
Genetic Counseling
Risk perception
Stigma
Control
Knowledge

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders