Impact of Genetic Counseling for Individuals With Mental Illness

Phase 3

Completed

• Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder
• Interventions: Behavioral: Genetic Counseling; Behavioral: Educational Booklet

• Registration Number: NCT00713804
• Lead Sponsor: University of British Columbia

Brief Summary

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.

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).

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Primary Completion: 2011-06
• Study Completion: 2011-11
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GC	Genetic Counseling	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.
EB	Educational Booklet	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.

Primary Outcome Measures

Name	Time	Method
Knowledge, risk perception, stigma, perceived control	immediately post intervention and 1 month post intervention

Trial Locations

Locations (1)

Centre for Complex Disorders, BC Mental Health and Addictions Research Institute; 🇨🇦 Vancouver, British Columbia, Canada