The main research goals in this protocol are 1) to determine whether disrupted extinction is also more common in patients with acquired brain injury (ABI) that are treated for anxiety and depression as in the previously studied anxiety population,…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
executieve functiestoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are 1) the proportion of patients with ABI who are
classified into the dysfunctional poor extinction class, that is hypothesized
to be at least similar or potentially larger to the proportion in an anxiety
disordered population, and significantly different from a healthy population,
both derived from previous studies. 2) the association between the extinction
class membership and executive strength, or, a composite score of cognitive
switching, updating and inhibition.
Secondary outcome
n/a
Background summary
Acquired Brain Injury (ABI) often leads to depressive and/ or anxiety
disorders, particularly when coping mechanisms are not sufficient for an
individual to adequately adapt to the new situation with often moderate to
severe loss of cognitive and physical function. Treatment for these disorders
may be inadequate when the treatment commonly used for anxiety and depressive
symptoms (cognitive behavioral therapy) relies on control, or executive
function mechanisms that are often impaired in this population. One function
that may be impaired is prefrontal regulation, including emotion regulation. A
laboratory model for prefrontal emotion regulation is the extinction of
conditioned fear. Previous data-driven analysis of individual differences in
the extinction of conditioned fear has shown that different learning patterns
can be distinguished that could be clinically relevant in the light of etiology
and treatment of anxiety and mood symptoms. This research uses a short (15-min)
conditioning experiment to classify these learning patterns. In populations of
patients with anxiety disorders, more people are classified in dysfunctional
learning patterns (impaired extinction and overreaction to stimuli that are not
threatening) compared to healthy subjects. Disrupted extinction can be a reason
that in some people learned fears are maintained, even when no longer adaptive.
This protocol therefore explores these processes in a population with acquired
brain injury (ABI). We hypothesize that the percentage of people with ABI who
are classified into the disrupted extinction group is similar to the percentage
found in the previous study in a population with an anxiety disorder without
ABI. Alternatively, this percentage may be even larger in the ABI group due to
additional vulnerability relating to impaired executive functions. If so, it
will be investigated in a follow-up study (not part of the current proposal)
whether this poor extinction group may profit less from ABI-adapted cognitive
behavioral therapy.
Study objective
The main research goals in this protocol are 1) to determine whether disrupted
extinction is also more common in patients with acquired brain injury (ABI)
that are treated for anxiety and depression as in the previously studied
anxiety population, and 2) whether in this population disturbed executive
functions are associated with disturbed extinction. In a follow-up study,
longitudinal data may also be collected to determine the success of whether a
disturbance of extinction is also related to treatment success in this
population (for this part separate approval will be requested).
Study design
This is an observational study, cross-sectional study.
Study burden and risks
Burden of participation consists of participation in a short conditioning
experiment and a neuropsychological test battery. The burden of the
conditioning is reduced by making it as short as possible and by using a
relatively mild unconditioned stimulus (a brief human scream). The
neuropsychological test battery is also kept as short as possible, is divided
across different occasions and includes as many breaks as necessary. Testing
will also be kept at a minimum by using results of neuropsychological tests
that have already been done as part of regular care if available.
Heidelberglaan 1
Utrecht 3584CS
NL
Heidelberglaan 1
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
Potential participants are selected from a ambulant patient population that are
following standard outpatient clinical care within the *Zorgpad Affectief*, one
of our care pathways, that is composed of multidisciplinary treatment for
anxiety and/or depression symptoms using CBT (standard, or adapted to cognitive
problems) in which cognitive, behavioural and exposure techniques are used. A
multidisciplinary team in which a neurologist and/or a psychiatrist
participates indicate whether participants are regarded to be cognitive,
intellectually and physically fit enough to profit from CBT. Patients in this
treatment program are therefore regarded to be fully able to provide informed
consent and be eligible to participate in the current study. The outpatients
that receive care at this clinic typically have light to moderate brain damage
in a chronic phase and are medically and neurologically stable, have mild to
moderate cognitive dysfunction, are independent in terms of activities of daily
living or receive some sort of coaching, but with persistent psychological
symptoms that are difficult to alleviate. No further criteria are set for the
severity of the symptoms.
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: age 18-65 years, with acquired brain injury (chronic
phase) and anxiety and/or depression symptoms, that are selected for CBT by a
multidisciplinary team as part of standard care typically for Thalamus
specialized mental care outpatient clinic (Pro Persona Wolfheze).
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: severe comorbidity (diagnosed with severe
chronic depression, bipolar disorder and/or psychosis) or substance abuse
disorder, hearing problems and inability to read or speak Dutch. Medication,
age, gender and diagnosis are used as cofounders for the analysis.
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 | NL77838.041.21 |