NCT00713804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

July 7, 2008

Last Update Submit

July 11, 2012

Conditions

Keywords

SchizophreniaBipolar DisorderSchizoaffective disorderGenetic CounselingRisk perceptionStigmaControlKnowledge

Outcome Measures

Primary Outcomes (1)

  • Knowledge, risk perception, stigma, perceived control

    immediately post intervention and 1 month post intervention

Study Arms (3)

GC

EXPERIMENTAL

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

EB

ACTIVE COMPARATOR

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

WT

NO INTERVENTION

Waitlist (WT)

Interventions

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

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.

EB

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPsychotic DisordersSocial Stigma

Interventions

Genetic Counseling

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Genetic ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jehannine Austin, PhD, CCGC, CGC

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Erin Michalak

    University of British Columbia

    STUDY DIRECTOR
  • William Honer, MD

    University of British Columbia

    STUDY DIRECTOR
  • Catriona Hippman, MSc

    University of British Columbia

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 11, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2011

Study Completion

November 1, 2011

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations