Testing the feasibility of testing FPS as part of an anxiety test battery several times on one test day (pilot study 1) and repeating this procedure across several test days (pilot study 2).
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is potentiation of the startle reflex during a
condition in which electrical stimuli may be administered in comparison to
startle during a safe condition in which electrical stimuli will never be
presented (FPS).
Secondary outcome
Skin conductance responses, subjective anxiety.
Background summary
Fear-Potentiated Startle (FPS) has been recognized as a powerful tool to assess
fear and anxiety in animal and human laboratory models. Human models so far
have developed procedures to allow multiple FPS test days for purpose of
cross-over pharmacological studies. However, for the purpose of screening novel
compounds of which the pharmacokinetics is still largely unknown, the method
could be improved by assessing FPS several times across one test day. This
protocol describes two relatively small pilot studies that test the feasibility
of testing FPS several times on one test day (pilot study 1) and repeating this
procedure across several test days (pilot study 2). In addition, several other
tests will be included to comprise an anxiety test battery that probes several
other aspects of anxiety.
Study objective
Testing the feasibility of testing FPS as part of an anxiety test battery
several times on one test day (pilot study 1) and repeating this procedure
across several test days (pilot study 2).
Study design
This protocol concerns two experimental studies in which FPS is tested several
times a day, and across several test days. The FPS test will be embedded in an
anxiety test battery that includes questionnaires measuring subjective levels
of anxiety and mental stress tests.
Intervention
All subjects undergo a Fear-Potentiated Startle test in which anxiety is
induced by means of threat of electrical stimuli administered to the wrist, and
evoking startle reflexes as a read-out measure. The FPS test is part of an
experimental psychology test battery.
Study burden and risks
The burden involves being present at the institute for a short screening visit
and during one test day (pilot study 1) or four test days (pilot study 2),
filling out several questionnaires, undergoing several repetitions of the FPS
and anxiety test battery, and waiting in between. Mild discomfort may be
experienced as a result of the stress inducing components in the test battery.
Waiting periods between the repetitions of the anxiety test battery is spent in
the waiting room where subjects can read or study for themselves. There is
minimal risk involved in participating in this study, apart from maybe
developing a mild rash in case the subject is hypersensitive to the electrode
material or the conductive paste.
Heidelberglaan 2
3584 CS Utrecht
Nederland
Heidelberglaan 2
3584 CS Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Subject is a legally competent adult, aged 18 to 40.
- Subject is familiar with the procedures of the study, and agrees to participate in the study program by giving written informed consent.
Exclusion criteria
- Subject is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of any significant psychiatric disorder(s). Subjects with extreme psychological responses in the personality questionnaires can be excluded.
- Subject has a history of any cardiac disorder or neurological disease.
- Subject has participated in another FPS trial prior to the start of the study.
- Subject is currently a regular user (including *recreational uses*) of any illicit drugs, or has (a history of) drug or alcohol abuse.
- Subject is unable to discern basic colours red, green and blue.
- Reduced startle reactivity, defined as no discernable response in at least 3 out of the 12 startle stimuli.
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 | NL18570.041.07 |