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Impact of Genetic Counseling for Individuals With Mental Illness

NCT ID: NCT00713804

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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).

Conditions

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Schizophrenia Bipolar Disorder Schizoaffective Disorder

Keywords

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Schizophrenia Bipolar Disorder Schizoaffective disorder Genetic Counseling Risk perception Stigma Control Knowledge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Genetic Counseling

Intervention Type BEHAVIORAL

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 (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.

Group Type ACTIVE_COMPARATOR

Educational Booklet

Intervention Type BEHAVIORAL

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

Waitlist (WT)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jehannine Austin, PhD, CCGC, CGC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Erin Michalak

Role: STUDY_DIRECTOR

University of British Columbia

William Honer, MD

Role: STUDY_DIRECTOR

University of British Columbia

Catriona Hippman, MSc

Role: STUDY_DIRECTOR

University of British Columbia

Locations

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Centre for Complex Disorders, BC Mental Health and Addictions Research Institute

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 26930535 (View on PubMed)

Other Identifiers

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H07-02427

Identifier Type: -

Identifier Source: org_study_id