|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of British Columbia |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00713804 |
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 III |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma. |
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
GC: Experimental
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.
|
|
EB: Active Comparator
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.
|
|
WT: No Intervention
Waitlist (WT)
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Jehannine Austin, PhD, CCGC, CGC | 604 875-4111 ext 68304 | jehannine.austin@ubc.ca |
| Contact: Research Coordinator | 604 875-2000 ext 4718 | mental.illness@ubc.ca |
| Canada, British Columbia | |
| Centre for Complex Disorders, BC Mental Health and Addictions Research Institute | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4H4 | |
| Contact: Research Coordinator 604 875-2000 ext 4718 mental.illness@ubc.ca | |
| 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
| Responsible Party: | University of British Columbia ( Dr. Jehannine Austin ) |
| Study ID Numbers: | H07-02427 |
| Study First Received: | July 7, 2008 |
| Last Updated: | July 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00713804 |
| Health Authority: | Canada: Health Canada |
|
Schizophrenia Bipolar Disorder Schizoaffective disorder Genetic Counseling |
Risk perception Stigma Control Knowledge |
|
Schizophrenia Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
|
Pathologic Processes Disease |
