Bipolar Disorder (BD)NCT00300820
Perspectives of Individuals With Bipolar Disorder and Siblings of Individuals With Bipolar Disorder; A Telephone Interview Study
An observational study of Bipolar Disorder (BD) and Bipolar, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will examine those who will seek and those who are most likely to benefit from genetic counseling for psychiatric disorders. It will identify themes related to perceived risks, benefits, and possible motivations for seeking genetic counseling among families affected by bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder (BD), Bipolar
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2006to 6 Feb 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over 18 years of age who have been diagnosed with bipolar disorder (per their own report; no screening will be performed), and/or the adult siblings of affected individuals. Participants do not have to be sibling pairs, i.e., an affected individual may be included without the participation of their unaffected sibling, and visa versa. Participants must be able to speak English fluently.
Who cannot join
- Those under 18 years of age will not be included. First-degree relatives other than full siblings will not be included. If a participant is symptomatic to the point that the interview is compromised, as determined by the PI who has considerable experience counseling affected individuals, the PI will end the interview and any data collected will be destroyed. If possible, the interview will be rescheduled. We will encourage symptomatic individuals to seek care from their mental health provider, or we will make a referral if the individual does not have a provider.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Seeking Genetic Counseling: What Motivates Families At Risk For Psychiatric Illness?
This study will examine those who will seek and those who are most likely to benefit from genetic counseling for psychiatric disorders. It will identify themes related to perceived risks, benefits, and possible motivations for seeking genetic counseling among families affected by bipolar disorder. It will then use those themes to generate a starting point for a framework to guide further research and to improve genetics services as they are currently practiced.
Adults with bipolar disorder and the adult siblings of people with bipolar disorder are eligible for this study. In a 60- to 90-minute telephone interview, participants are asked questions related to their thoughts about the causes of bipolar disorder, their experiences with the illness, their concerns about the disorder occurring again in their families, and their feelings about the value of discussing these issues with health care professionals. They also are asked questions about the mental health of their close family members and their own mental health.
Read the detailed description
This study aims to examine through the use of qualitative telephone interviews who will seek, and who is most likely to benefit from, genetic counseling for psychiatric disorders. The specific aims are to identify themes related to perceived risks, benefits, and possible motivations for seeking genetic counseling among families affected by bipolar disorder; to use those themes to generate a starting point for a conceptual framework to guide further research; and to use those themes to improve clinical genetics services currently in practice.
None of the few available studies on genetics and bipolar disorder evaluate interest in genetic services in the absence of genetic testing (e.g., family-history-based risk assessment, education about etiology, psychological support) even though those elements will continue to be relevant even if genetic testing becomes available. Only one study asked any questions about psychiatric genetic counseling in the absence of testing-a study on schizophrenia in which one such question was posed. In most of the available literature, the focus is on highly predictive testing scenarios that are not relevant in current practice, and may never be relevant. In addition, most studies test the researchers' preconceived notions of risks and benefits, without allowing participant input. More research will facilitate the integration of genetic counseling for psychiatric disorders into the genetics clinic.
This is a qualitative study using telephone interviews that will be taped and transcribed. We plan to interview 15 to 25 adults affected with bipolar disorder and 15 to 25 unaffected adult siblings. We will use a semi-structured interview guide that will allow the integration of new elements and the modification of existing elements. We will use data reduction and coding to synthesize the most important themes.
This study will result in themes that can be tested in a larger, more representative sample, allowing us to test hypotheses about interest in psychiatric genetic counseling. This study also will provide preliminary data about anticipating, through the use of realistic scenarios, the point at which individuals are more likely to embrace psychiatric genetic counseling; and beginning to understand, in a broader perspective, what may increase or decrease interest in genetic counseling and risk assessment based on family history for complex disorders. More immediately, this study will provide a description of the experience of living with risk in the family that should be of interest to genetics professionals.
- Conditions
- Bipolar Disorder (BD), Bipolar
- Keywords
- Bipolar Disorder, Affected Adults and Adult Siblings, Interest in Genetic Counseling, Bipolar, Genes, Familial, Education, Testing, BP, Adult Siblings
- Medical subject headings
- Bipolar Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study start2 Mar 2006
- Study completion6 Feb 2008
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 Bipolar Disorder (BD)Studies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300820
- Sponsor's protocol ID
- 060108
- Other IDs
- 06-HG-0108
- Status last verified
- 6 Feb 2008
- First submitted
- 8 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hodgkinson KA, Murphy J, O'Neill S, Brzustowicz L, Bassett AS. Genetic counselling for schizophrenia in the era of molecular genetics. Can J Psychiatry. 2001 Mar;46(2):123-30. doi: 10.1177/070674370104600202.
PubMed 11280080
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeking Genetic Counseling: What Motivates Families At Risk For Psychiatric Illness?
- ClinicalTrials.gov ID
- NCT00300820
- Acronym / sponsor ID
- 060108
- Conditions
- Bipolar Disorder (BD), Bipolar
- Keywords
- Bipolar Disorder, Affected Adults and Adult Siblings, Interest in Genetic Counseling, Bipolar, Genes, Familial, Education, Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 2 Mar 2006
- Study completion
- 6 Feb 2008
- First posted
- 9 Mar 2006 (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.
This study will examine those who will seek and those who are most likely to benefit from genetic counseling for psychiatric disorders. It will identify themes related to perceived risks, benefits, and possible motivations for seeking genetic counseling among families affected by bipolar disorder. It will then use those themes to generate a starting point for a framework to guide further research and to improve genetics services as they are currently practiced.
Adults with bipolar disorder and the adult siblings of people with bipolar disorder are eligible for this study. In a 60- to 90-minute telephone interview, participants are asked questions related to their thoughts about the causes of bipolar disorder, their experiences with the illness, their concerns about the disorder occurring again in their families, and their feelings about the value of discussing these issues with health care professionals. They also are asked questions about the mental health of their close family members and their own mental health.
Detailed description
This study aims to examine through the use of qualitative telephone interviews who will seek, and who is most likely to benefit from, genetic counseling for psychiatric disorders. The specific aims are to identify themes related to perceived risks, benefits, and possible motivations for seeking genetic counseling among families affected by bipolar disorder; to use those themes to generate a starting point for a conceptual framework to guide further research; and to use those themes to improve clinical genetics services currently in practice.
None of the few available studies on genetics and bipolar disorder evaluate interest in genetic services in the absence of genetic testing (e.g., family-history-based risk assessment, education about etiology, psychological support) even though those elements will continue to be relevant even if genetic testing becomes available. Only one study asked any questions about psychiatric genetic counseling in the absence of testing-a study on schizophrenia in which one such question was posed. In most of the available literature, the focus is on highly predictive testing scenarios that are not relevant in current practice, and may never be relevant. In addition, most studies test the researchers' preconceived notions of risks and benefits, without allowing participant input. More research will facilitate the integration of genetic counseling for psychiatric disorders into the genetics clinic.
This is a qualitative study using telephone interviews that will be taped and transcribed. We plan to interview 15 to 25 adults affected with bipolar disorder and 15 to 25 unaffected adult siblings. We will use a semi-structured interview guide that will allow the integration of new elements and the modification of existing elements. We will use data reduction and coding to synthesize the most important themes.
This study will result in themes that can be tested in a larger, more representative sample, allowing us to test hypotheses about interest in psychiatric genetic counseling. This study also will provide preliminary data about anticipating, through the use of realistic scenarios, the point at which individuals are more likely to embrace psychiatric genetic counseling; and beginning to understand, in a broader perspective, what may increase or decrease interest in genetic counseling and risk assessment based on family history for complex disorders. More immediately, this study will provide a description of the experience of living with risk in the family that should be of interest to genetics professionals.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals over 18 years of age who have been diagnosed with bipolar disorder (per their own report; no screening will be performed), and/or the adult siblings of affected individuals. Participants do not have to be sibling pairs, i.e., an affected individual may be included without the participation of their unaffected sibling, and visa versa. Participants must be able to speak English fluently.
Key exclusion criteria (1 listed)
- Those under 18 years of age will not be included. First-degree relatives other than full siblings will not be included. If a participant is symptomatic to the point that the interview is compromised, as determined by the PI who has considerable experience counseling affected individuals, the PI will end the interview and any data collected will be destroyed. If possible, the interview will be rescheduled. We will encourage symptomatic individuals to seek care from their mental health provider, or we will make a referral if the individual does not have a provider.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 11280080Hodgkinson KA, Murphy J, O'Neill S, Brzustowicz L, Bassett AS. Genetic counselling for schizophrenia in the era of molecular genetics. Can J Psychiatry. 2001 Mar;46(2):123-30. doi: 10.1177/070674370104600202.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder (BD) and Bipolar, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
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 1 inclusion and 1 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 2 Jul 2017. 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 United States. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300820, 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 2 Jul 2017.