NCT01012180

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

October 23, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2013

Completed
Last Updated

April 5, 2018

Status Verified

June 7, 2013

First QC Date

November 10, 2009

Last Update Submit

April 4, 2018

Conditions

Keywords

Bipolar DisorderAdaptationParentsRiskCopingSurvey

Outcome Measures

Primary Outcomes (1)

  • Adaptation to bipolar disorder.

Secondary Outcomes (1)

  • Coping with perceived risk of bipolar to ones children.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

NAMI Research Institute

Bethesda, Maryland, United States

Location

Related Publications (3)

  • 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.

    PMID: 16958030BACKGROUND
  • Broadbent 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.

    PMID: 16731240BACKGROUND
  • Carver 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.

    PMID: 16250744BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Barbara B Biesecker

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

October 23, 2009

Study Completion

June 7, 2013

Last Updated

April 5, 2018

Record last verified: 2013-06-07

Locations