SchizophreniaPhase 3NCT00713804
Impact of Genetic Counseling for Individuals With Mental Illness
A Phase 3 study testing Genetic Counseling and Educational Booklet in people with Schizophrenia and Bipolar Disorder, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- What is being tested?
- Genetic Counseling and Educational Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Complex Disorders, BC Mental Health and Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: 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.
Read the 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).
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Being tested
- Genetic Counseling, Educational Booklet
- Keywords
- Schizophrenia, Bipolar Disorder, Schizoaffective disorder, Genetic Counseling, Risk perception, Stigma, Control, Knowledge
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic CounselingBehavioural
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.
Educational BookletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational Booklet |
| WT | No intervention | Waitlist (WT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, risk perception, stigma, perceived control
Measured: immediately post intervention and 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jehannine Austin, PhD, CCGC, CGC, Principal investigator, University of British ColumbiaErin Michalak, Study director, University of British ColumbiaWilliam Honer, MD, Study director, University of British ColumbiaCatriona Hippman, MSc, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713804
- Sponsor's protocol ID
- H07-02427
- Status last verified
- Jul 2012
- First submitted
- 7 Jul 2008
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26930535
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.
- ClinicalTrials.gov ID
- NCT00713804
- Acronym / sponsor ID
- H07-02427
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Keywords
- Schizophrenia, Bipolar Disorder, Schizoaffective disorder, Genetic Counseling, Risk perception, Stigma, Control, Knowledge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GC | Experimental | Behavioral: Genetic CounselingGenetic 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 | Active comparator | Behavioral: Educational BookletEducational 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. |
| WT | No intervention | –Waitlist (WT) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic CounselingOne 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. | Behavioural | GC |
| Educational BookletOne 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. | Behavioural | EB |
Primary outcome
Knowledge, risk perception, stigma, perceived control
Time frame: immediately post intervention and 1 month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Derived from this study: PubMed 26930535Hippman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jehannine Austin, PhD, CCGC, CGC principal investigator
University of British Columbia
Erin Michalak study director
University of British Columbia
William Honer, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genetic Counseling and Educational Booklet in people with Schizophrenia and Bipolar Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, risk perception, stigma, perceived control (time frame: immediately post intervention and 1 month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00713804, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.