Impact of Genetic Counseling for Individuals With Mental Illness

Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Intervention / Treatment: Behavioral: Genetic Counseling; Behavioral: Educational Booklet

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • Centre for Complex Disorders, BC Mental Health and Addictions Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knowledge, risk perception, stigma, perceived control	immediately post intervention and 1 month post intervention

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Study Director: William Honer, MD, University of British Columbia; Principal Investigator: Jehannine Austin, PhD, CCGC, CGC, University of British Columbia; Study Director: Erin Michalak, University of British Columbia; Study Director: Catriona Hippman, MSc, University of British Columbia

Publications and helpful links

General Publications

• Hippman C, Ringrose A, Inglis A, Cheek J, Albert AY, Remick R, Honer WG, Austin JC. A pilot randomized clinical trial evaluating the impact of genetic counseling for serious mental illnesses. J Clin Psychiatry. 2016 Feb;77(2):e190-8. doi: 10.4088/JCP.14m09710.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 11, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Schizophrenia; Bipolar Disorder; Stigma; Control; Knowledge; Schizoaffective disorder; Risk perception; Genetic Counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: H07-02427