The objective of this study is to assess the added value of polygenic risk scoring in psychiatric genetic counseling for patients with serious mental illness (SMI) and their family members. The secondary objective of this study is to explore…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To examine potential benefits of genetic counseling provided with PRS as
compared to genetic counseling without PRS and to care as usual for people with
serious mental illness (SMI) and their family members.
Secondary outcome
The secondary objective of this study is to explore attitudes of patients with
SMI and their family members towards PRS. Third, we will explore knowledge and
attitudes towards PRS in mental health professionals.
Background summary
Psychiatric disorders are highly prevalent and etiologically complex, with both
genetic and environmental factors contributing to disease risk. This complex
etiology often results in misunderstanding the cause of the disorder by
patients and family members and overestimating the genetic contribution to the
disorder. Genetic counseling helps people with mental illness and their family
members by gaining more knowledge about the origins of their mental illness,
correcting misconceptions, and promoting health-enhancing behaviors, leading to
a sense of empowerment. Recently, polygenic risk scores (PRS) have gained
increasing interest. Early findings suggest that PRS might allow for
identification of individuals at-risk for psychiatric disorders, treatment
optimization, and enhancement of prognostic accuracy. However, PRS is not yet
implemented in clinical practice. The positive effect of genetic counseling
could be further enhanced by providing even more individualized information
using PRS.
Study objective
The objective of this study is to assess the added value of polygenic risk
scoring in psychiatric genetic counseling for patients with serious mental
illness (SMI) and their family members. The secondary objective of this study
is to explore attitudes of patients with SMI and their family members towards
the calculation and provision of PRS. Third, we will explore knowledge and
attitudes towards PRS in mental health professionals.
Study design
The study is designed as a mixed-methods, prospective, non-randomized three-arm
pilot study. It is a monocenter study, with collaborating referring centers.
Intervention: For the quantitative study, one group receives personalized
genetic counseling based on familial and medical history and clinical
characteristics, one group receives personalized genetic counseling as
mentioned above, provided with polygenic risk scoring, and one group receives
care as usual. Allocation to a group is based on the preferences of each
individual. For the qualitative study, an open, in-depth interview will be
held, where participants can choose whether they want to participate or not.
Study burden and risks
Participants in the PRS-intervention group will have one blood sample drawn for
DNA-extraction. This venipuncture entails the risk of a hematoma. We aim to
minimize this risk by only allowing experienced personnel to perform the blood
draw. No serious health risks are associated with this study.
Time investment is considered substantial. However, previous data on
psychiatric genetic counselling report high participant satisfaction.
Participants will have a telephone screening of +-15 minutes, two face-to-face
contacts of 30 to 60 minutes, and a telephone follow-up contact of +-30
minutes. Participants who choose to participate in the qualitative study, will
receive an additional interview of 60-120 minutes. This may take place at the
participant*s home if preferred, to minimize burden.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a participant must meet all of the
following criteria:
(1) The participant has been diagnosed with SMI, which is defined as having a
psychosis spectrum disorder or bipolar disorder, or is a first-degree family
member of a patient diagnosed with SMI.
(2) The participant is at least 16 years old;
(3) The participant must be able to speak and read the Dutch language;
(4) The participant must be mentally competent and have decisional capacity
with regard to a decision in participating in the current study, which will be
assessed by the (treating) physician.
Exclusion criteria
A potential participant who meets any of the following criteria will be
excluded from participation in this study:
(1) The participant is admitted involuntary to a psychiatric unit in the
context of a *crisismaatregel*;
(2) The participant was previously diagnosed with a clinically relevant genetic
diagnosis;
(3) The experienced psychiatric episode was primarily substance-induced.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77163.041.21 |
| Other | volgt |