Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00300820
Other study ID # 060108
Secondary ID 06-HG-0108
Status Completed
Phase N/A
First received March 8, 2006
Last updated June 30, 2017
Start date March 2, 2006
Est. completion date February 6, 2008

Study information

Verified date February 6, 2008
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 6, 2008
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02133170 - "Mindfulness vs Psychoeducation in Bipolar Disorder" N/A
Completed NCT02189057 - A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management Of Depression N/A
Completed NCT00666432 - Bipolar and Schizophrenia Consortium for Parsing Intermediate Phenotypes
Completed NCT02184767 - Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication Phase 1
Terminated NCT01131559 - Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression Phase 3
Recruiting NCT01047215 - Heart Rate Changes in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine Phase 4
Enrolling by invitation NCT00969930 - Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE N/A