Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness

NCT00714818 | Completed Phase 3

• 1 other identifier: H07-02706
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• knowledge

  immediately post intervention and 1 month post intervention

• risk perception

  immediately post intervention and 1 month post intervention

• stigma

  immediately post intervention and 1 month post intervention

• perceived control

  immediately post intervention and 1 month post intervention

Study Arms (3)

GC

EXPERIMENTAL

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

EB

ACTIVE COMPARATOR

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

Behavioral: Genetic Counseling

WT

NO INTERVENTION

Waitlist

Interventions

Genetic Counseling 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

GC

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

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

Vancouver, British Columbia, V5A 4H4, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders; Social Stigma

Interventions

Genetic Counseling

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jehannine Austin, PhD, CCGC, CGC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Catriona Hippman

  University of British Columbia

  STUDY DIRECTOR

• Erin Michalak

  University of British Columbia

  STUDY DIRECTOR

• William Honer, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

CA (1)