The primary objectives are to: (1) Examine whether emotional incongruence (i.e., the mismatch between self-reported emotion and observed emotion from facial expression) is more common in patients with FND than non-FND control groups (healthy…
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter for the first objective is emotional incongruence.
Emotional incongruence is quantified by the difference between self-reported
emotion describing an unpleasant interpersonal interaction compared to an
observable nonverbal expression of emotions. Observable nonverbal emotions will
be quantified using facial expression of negative emotions using software-based
analyses of digitized video recordings (FaceReader). This study will
specifically focus on the emotion of self-reported and nonverbally expressed
anger. The main study parameter for the secondary objective is the clinical
course of FND-symptoms in patients with FND. The clinical course will be
determined by the Clinical Global Impressions (CGI)-scale as primary outcome,
and symptom status, quality of life and referral for FND-related intervention
as secondary outcome measures. For the ancillary objectives, participants will
also complete questionnaires to assess background psychological measures and
the electronic patient records will be used to obtain clinical information
relevant to FND.
Secondary outcome
Secondary study parameters for primary objective 1 will be:
- The congruency between the clinician observed anger and patient-reported
anger will be measured by the clinical interview and the referring physician
form assessed at T0.
- The Anger-EMIN scores during the other phases of the interview, assessed at
T0.
Secondary study parameters for primary objective 2 will be:
- Quality of life assessed using the Short Form 12 (SF-12) and the Mental
health-Quality of Life (MH-QoL) questionnaires.
- The levels of pain and fatigue as measured by the Numeric Rating Scale for
Pain and Fatigue (NRS-PF).
- Referral for psychological or psychiatric treatment, as measured by the
results of the *Assessment of treatments received by the patient* at 12 months
follow-up (T3).
- Symptoms of depression, measured by the Patient Health Questionnaire-9
(PHQ-9) assessed at T0-T3.
- Symptoms of anxiety, measured by the Generalized anxiety Disorder-7 (GAD-7)
assessed at T0-T3.
Background summary
Functional neurological disorder (FND) is common in clinical practice, with
prevalence estimates of 16% in neurology outpatient settings. The aetiology and
predictors of the clinical course of FND are insufficiently understood. Prior
research indicates that psychological factors related to emotion perception and
expression contribute to the development of FND, particularly anger-related
emotions. The present study investigates the role of the mismatch between the
patients* self-expression of emotions and observable nonverbal emotions from
facial expression as related to FND and its clinical course during a one-year
follow-up.
Study objective
The primary objectives are to: (1) Examine whether emotional incongruence
(i.e., the mismatch between self-reported emotion and observed emotion from
facial expression) is more common in patients with FND than non-FND control
groups (healthy controls and patients with neurological disorders); and (2)
determine whether emotional incongruence is predictive of the clinical course
of FND. The secondary objective is to establish clinical and psychosocial
correlates of emotional incongruence in patients with FND.
Study design
This is a cross-sectional between-groups design (primary objective 1), combined
with a longitudinal design (primary objective 2) including four assessments
during a follow-up of one year.
Study burden and risks
Patients are asked to come to the hospital for a one-hour visit within two
weeks after being diagnosed with FND (either at the emergency department or at
a neurology outpatient visit). During the first research visit, patients will
be interviewed for 30 minutes and complete questionnaires (30 min); an
additional 10 min is reserved for informed consent and other study-related
assessments as described in the study protocol. After 3, 6 and 12 months,
follow-up assessments will be made using questionnaires (30 min) and measures
of behavior (20 min). Patients are also asked for permission to review their
medical records and contact of their primary care physician to document health
care utilization (relevant to primary objective 2). This is an observational
longitudinal study and no pharmacological agents or devices will be used. The
risk for worsening of FND-symptoms due to participation in this study is low.
dr. Deelenlaan 5
Tilburg 5042 AD
NL
dr. Deelenlaan 5
Tilburg 5042 AD
NL
Listed location countries
Age
Inclusion criteria
Patients with FND:
- Age >= 18 years
- Diagnosis of FND
- Diagnosis is made by a neurologist
- Diagnosis is based on, at least, clinical history and neurological
examination
Participants of all ethnic backgrounds, both female and male patients will be
enrolled in this study. There is no upper age limit.
Healthy controls (control group 1)
- Age >= 18 years
- Not having a psychiatric disorder
- Not having a neurologic disease
Participants of all ethnic backgrounds, both female and male patients will be
enrolled in this study group.
Neurological control group (Spinal disc herniation (SDH) / Migraine, control
group 2)
- Age >= 18 years,
- Diagnosis of:
o Spinal disc herniation, based on clinical symptoms and matching MRI-images
o Migraine, formal diagnosis according to the Dutch guidelines. Diagnosis is
made by neurologist
Participants of all ethnic backgrounds, both female and male patients will be
enrolled in this study group.
Exclusion criteria
A potential participant will be excluded from participation in this study if
one or more of the following criteria applies:
• A known diagnosis of autism spectrum disorder (ASD) because, according to the
DSM-5, verbal and non-verbal communication is often not well integrated in ASD,
and this may interfere with the measurement of Anger-EMIN.
• Psychotic disorder. Rationale: the negative symptoms of a psychotic disorder
involve a reduction of emotional expression which may interfere with the
results.
• Impairment interfering with performing the tasks needed for the study (e.g.,
blindness, aphasia, severe tremor).
• Not fluent in the Dutch language. Rationale: all questionnaires and tests are
provided in Dutch. Participants who do not understand the Dutch language cannot
participate.
• Life expectancy of less than one year.
• Refusal to informed consent.
A medical history of neurological disorder, a previous episode of functional
neurological complaints or another medical disorder is not exclusionary for the
FND group.
4.3.2 Healthy controls
A potential healthy control participant who meets any of the following criteria
will be excluded from participation in this study:
• Exclusion criteria as applied for FND.
4.3.3 Spinal disc herniation (SDH) / Migraine controls
A potential neurological control participant who meets any of the following
criteria will be excluded from participation in this study:
• Exclusion criteria as applied for FND.
• A current or prior diagnosis of FND.
• Patients who daily use opiates or benzodiazepines
A non-recent diagnosis of migraine and spinal disk herniation is not
exclusionary because the FND-group can also include patients who do not have a
first episode of FND.
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 | NL76176.028.20 |