Bipolar DisorderNCT01012180
Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child
An observational study of Bipolar Disorder, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
Trial summary
Background: Bipolar disorder is a common mood disorder that affects 1% to 2% of the population. Individuals with bipolar disorder tend to have periods of mania that are characterized by extra energy, very poor judgment or unrealistic beliefs about their thoughts and abilities, and an inability to complete thoughts and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 266 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2009to 7 Jun 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of bipolar disorder
- Be 18 years or older
- Be a biological parent of a child who is younger than 30 years old
- Be willing to participate in the survey
- The participant must be (or must have been) the primary caretaker for his or her child.
Who cannot join
- A participant must meet inclusion criteria.
- A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder.
- A participant s child cannot have been adopted.
- The participant s child cannot be 30 years of age or older.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
NAMI Research Institute
Bethesda, Maryland
About this study
Background:
- Bipolar disorder is a common mood disorder that affects 1% to 2% of the population. Individuals with bipolar disorder tend to have periods of mania that are characterized by extra energy, very poor judgment or unrealistic beliefs about their thoughts and abilities, and an inability to complete thoughts and tasks; as well as major depressive episodes. The range and frequency of symptoms in affected individuals can vary greatly. Most individuals have cyclical symptoms and spend more time in a normal mood state than in an overtly symptomatic state.
- Relatives of individuals with bipolar disorder have an increased risk for bipolar disorder and other mood disorders. Currently, risk assessment for recurrence of a mood disorder is based on family and medical histories; genetic testing has not proved particularly useful to date for assessing risks of a mood disorder.
- Despite its prevalence, there is limited research on coping with bipolar illness. No published studies have examined adaptation to living with bipolar disorder or risk for bipolar disorder. More specifically, though a positive family history is the most important known risk factor for bipolar disorder, there are no published studies about response to the threat of future illness onset in children, risk modification efforts undertaken by affected parents, or coping with the risk for illness in children.
Read more
Objectives:
- To examine parents appraisals of the impact and cause of bipolar disorder, and the association with their perceived risk for bipolar illness in their child and how they cope with their perception of risk to their child.
- To assess whether parents adaptation to their own illness is associated with coping with perceived risk to their child.
- To describe parents coping strategies related to perceived risk in their children.
Eligibility:
- Men and women at least 18 years of age who have been diagnosed with bipolar disorder and who have at least one biological child (30 years of age or younger). Participants must be a primary caregiver for their children.
Design:
- Participants in this study will take an online survey and answer questions about disease perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder, addressing issues such as the following:
- Assessing the threat of bipolar disorder and coping with one s own illness.
- Optimism/pessimism of the individual coping with the illness.
- Perception of risk to a child, and coping with the perceived risk.
- Data from this study will not be shared with the participants/respondents.
Read the detailed description
Though psychiatric disorders are extremely common and individuals with bipolar disorder have reproductive fitness approaching population rates, we know very little about the perceptions and coping of parents with bipolar disorder related to their at-risk children. Bipolar disorder is an etiologically-complex psychiatric disorder that is caused by a combination of genetic and environmental risk factors. This study proposes to assess perceptions of parents with bipolar disorder about their illness, response to illness threat, and concerns about their children s risks. We then propose to assess whether those appraisals are associated with the outcomes of coping strategies and adaption. As informed by the Transactional Theory of Stress and Coping, we propose to use a web-based survey to examine disease perceptions, coping strategies, and adaptation to the disorder. Respondents will be recruited through the National Alliance of the Mentally Ill (NAMI). The study is cross-sectional and the survey is composed of several valid and reliable scales to measure the constructs predicted to be involved in adaptation. Open-ended questions are included to help interpret results from the measures. Knowledge about parents perceptions and coping with their own illness and with risk to children may lead to studies of potential coping interventions. Ultimately, downstream studies may help to improve parents adaptation to their own condition and how successfully they are able to manage concerns about perceived risks to their child.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Adaptation, Parents, Risk, Coping, Survey
- Medical subject headings
- Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation to bipolar disorder.
Secondary outcomes (1)
Coping with perceived risk of bipolar to ones children.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study start23 Oct 2009
- Study completion7 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Time perspective
- Other
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012180
- Sponsor's protocol ID
- 999910007
- Other IDs
- 10-HG-N007
- Status last verified
- 7 Jun 2013
- First submitted
- 10 Nov 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Austin JC, Smith GN, Honer WG. The genomic era and perceptions of psychotic disorders: genetic risk estimation, associations with reproductive decisions and views about predictive testing. Am J Med Genet B Neuropsychiatr Genet. 2006 Dec 5;141B(8):926-8. doi: 10.1002/ajmg.b.30372.
PubMed 16958030Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
PubMed 16250744
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child
- ClinicalTrials.gov ID
- NCT01012180
- Acronym / sponsor ID
- 999910007
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Adaptation, Parents, Risk, Coping, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 23 Oct 2009
- Study completion
- 7 Jun 2013
- First posted
- 11 Nov 2009 (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.
Background:
- Bipolar disorder is a common mood disorder that affects 1% to 2% of the population. Individuals with bipolar disorder tend to have periods of mania that are characterized by extra energy, very poor judgment or unrealistic beliefs about their thoughts and abilities, and an inability to complete thoughts and tasks; as well as major depressive episodes. The range and frequency of symptoms in affected individuals can vary greatly. Most individuals have cyclical symptoms and spend more time in a normal mood state than in an overtly symptomatic state.
- Relatives of individuals with bipolar disorder have an increased risk for bipolar disorder and other mood disorders. Currently, risk assessment for recurrence of a mood disorder is based on family and medical histories; genetic testing has not proved particularly useful to date for assessing risks of a mood disorder.
- Despite its prevalence, there is limited research on coping with bipolar illness. No published studies have examined adaptation to living with bipolar disorder or risk for bipolar disorder. More specifically, though a positive family history is the most important known risk factor for bipolar disorder, there are no published studies about response to the threat of future illness onset in children, risk modification efforts undertaken by affected parents, or coping with the risk for illness in children.
Objectives:
- To examine parents appraisals of the impact and cause of bipolar disorder, and the association with their perceived risk for bipolar illness in their child and how they cope with their perception of risk to their child.
- To assess whether parents adaptation to their own illness is associated with coping with perceived risk to their child.
- To describe parents coping strategies related to perceived risk in their children.
Eligibility:
- Men and women at least 18 years of age who have been diagnosed with bipolar disorder and who have at least one biological child (30 years of age or younger). Participants must be a primary caregiver for their children.
Design:
- Participants in this study will take an online survey and answer questions about disease perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder, addressing issues such as the following:
- Assessing the threat of bipolar disorder and coping with one s own illness.
- Optimism/pessimism of the individual coping with the illness.
- Perception of risk to a child, and coping with the perceived risk.
- Data from this study will not be shared with the participants/respondents.
Detailed description
Though psychiatric disorders are extremely common and individuals with bipolar disorder have reproductive fitness approaching population rates, we know very little about the perceptions and coping of parents with bipolar disorder related to their at-risk children. Bipolar disorder is an etiologically-complex psychiatric disorder that is caused by a combination of genetic and environmental risk factors. This study proposes to assess perceptions of parents with bipolar disorder about their illness, response to illness threat, and concerns about their children s risks. We then propose to assess whether those appraisals are associated with the outcomes of coping strategies and adaption. As informed by the Transactional Theory of Stress and Coping, we propose to use a web-based survey to examine disease perceptions, coping strategies, and adaptation to the disorder. Respondents will be recruited through the National Alliance of the Mentally Ill (NAMI). The study is cross-sectional and the survey is composed of several valid and reliable scales to measure the constructs predicted to be involved in adaptation. Open-ended questions are included to help interpret results from the measures. Knowledge about parents perceptions and coping with their own illness and with risk to children may lead to studies of potential coping interventions. Ultimately, downstream studies may help to improve parents adaptation to their own condition and how successfully they are able to manage concerns about perceived risks to their child.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of bipolar disorder
- Be 18 years or older
- Be a biological parent of a child who is younger than 30 years old
- Be willing to participate in the survey
- The participant must be (or must have been) the primary caretaker for his or her child.
Key exclusion criteria (4 listed)
- A participant must meet inclusion criteria.
- A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder.
- A participant s child cannot have been adopted.
- The participant s child cannot be 30 years of age or older.
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
Adaptation to bipolar disorder.
1 secondary outcome
Coping with perceived risk of bipolar to ones children.
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 5 Apr 2018.
- Background: PubMed 16958030Austin JC, Smith GN, Honer WG. The genomic era and perceptions of psychotic disorders: genetic risk estimation, associations with reproductive decisions and views about predictive testing. Am J Med Genet B Neuropsychiatr Genet. 2006 Dec 5;141B(8):926-8. doi: 10.1002/ajmg.b.30372.
- Background: PubMed 16731240Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Background: PubMed 16250744Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
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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.
Barbara B Biesecker principal investigator
National Human Genome Research Institute (NHGRI)
2 sites 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, run by National Human Genome Research Institute (NHGRI) at 2 sites 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 5 inclusion and 4 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Adaptation to bipolar disorder.. 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 NCT01012180, which also lists 3 linked publications.
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 5 Apr 2018.