Clinical trial NCT00714818: Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness
Official title: Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Keywords: 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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 13
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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

Primary outcomes:
measure: knowledge
timeFrame: immediately post intervention and 1 month post intervention
measure: risk perception
timeFrame: immediately post intervention and 1 month post intervention
measure: stigma
timeFrame: immediately post intervention and 1 month post intervention
measure: perceived control
timeFrame: immediately post intervention and 1 month post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Complex Disorders, BC Mental Health and Addictions Reserach Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jehannine Austin, PhD, CCGC, CGC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Catriona Hippman
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Erin Michalak
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: William Honer, MD
role: STUDY_DIRECTOR
References: