Case series study (10 persons with epilepsy-related anxiety symptoms and/ or posttraumatic stress):-To examine the potential effects of EMDR therapy in terms of reducing anxiety, from pre-treatment to post-treatment. Randomized controlled trial (75…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are:
Anxiety:
-Hospital Anxiety and Depression Scale- anxiety
-Symptom Checklist-90-R- anxiety
-Severity of PTSD symptoms (PTSD Checklist for Diagnostic and Statistical
Manual of Mental Disorders-Fifth Edition)
-Self-reported anxiety (diary)
Physiological stress:
-Electrocardiography (ECG) heart rate variability (standard deviation of the NN
(R-R) intervals, low and high frequency activity)
Secondary outcome
De secundary outcome measures are:
• Self-reported number of seizures (diary)
• Seizure severity (Liverpool Seizure Severity Scale 2.0)
• Quality of life (Quality of Life in Epilepsy - 31)
• Number of sessions needed to reduce the level of subjective distress related
to the most stressful memory/scenario to zero
Other study parameters/ possible confounders are:
• Demographics (General questionnaire)
• Treatment expectation (General questionnaire)
• Disease characteristics (General questionnaire)
• Personality (NEO Five-Factor Personality Inventory)
• Depression (Hospital Anxiety and Depression Scale- depression)
• Chronic everyday stress (Everyday Problem Checklist)
• Psychopathology (Symptom Checklist-90-R)
Background summary
Anxiety disorders are present in about 14-25% of people with epilepsy. The
unpredictable and uncontrollable nature of epilepsy often results in anxiety
and posttraumatic stress symptoms, which may provoke new seizures.
Psychological interventions may be beneficial to break this vicious cycle. The
current study aims to compare cognitive behavioural therapy (CBT), eye movement
desensitization and reprocessing (EMDR) therapy and a wait-list condition in
treating posttraumatic stress and/ or anxiety symptoms related to epilepsy.
Study objective
Case series study (10 persons with epilepsy-related anxiety symptoms and/ or
posttraumatic stress):
-To examine the potential effects of EMDR therapy in terms of reducing anxiety,
from pre-treatment to post-treatment.
Randomized controlled trial (75 persons with epilepsy-related anxiety symptoms
and/ or posttraumatic stress):
-To examine the efficacy of CBT and EMDR therapy in comparison to a wait-list
condition in terms of reducing anxiety and physiological stress and
consequently in reducing seizure frequency and severity and improving quality
of life, from pre-treatment to post-treatment.
-To compare the efficiency of CBT and EMDR therapy in persons with
epilepsy-related anxiety symptoms and/ or posttraumatic stress, in terms of the
number of sessions needed to reduce the level of subjective distress related to
the most disturbing memory or scenario.
Study design
A case series study with repeated measurements will first be conducted,
followed by a randomized controlled trial with a repeated measures design.
Intervention
CBT and EMDR therapy will be delivered using a maximum of 10 sessions of 90
minutes by experienced therapists. CBT and EMDR are both standardized
trauma-focused treatments. CBT is intended to reduce the level of distress
related to the traumatic event or scenario and correct dysfunctional thoughts
using imaginal exposure. EMDR therapy is intended to reduce the level of
distress related to a traumatic event or scenario (flash-forward) through
working memory taxation.
Study burden and risks
The case series study includes three time points (i.e. before treatment,
directly after treatment, and 3 months after treatment). Participants will be
requested to complete online questionnaires regarding demographics, treatment
expectation, disease characteristics, seizure severity, anxiety and PTSD
symptom severity (30 minutes at baseline; 15 minutes at later time points).
Participants will be asked to indicate their level of anxiety and seizure
occurrence on a daily basis (2-3 minutes per diary registration).
The randomized controlled trial includes four time points (i.e. before
treatment, directly after treatment, 3 and 6 months after treatment).
Participants will be requested to complete online questionnaires regarding
demographics, treatment expectation, disease characteristics, seizure severity,
anxiety, PTSD symptom severity, quality of life, personality, depression,
chronic everyday stress and psychopathology (60 minutes at baseline; 30-45
minutes at later time points). During CBT and EMDR therapy, participants will
be asked to wear an ECG sensor to collect measures of physiological stress
(heart rate variability). Furthermore, during the study participants will be
asked to indicate their level of anxiety and seizure occurrence on a daily
basis (2-3 minutes per diary registration).
CBT and EMDR therapy will be provided by experienced therapists and are already
part of the standard psychological treatment at SEIN. There is a minimal risk
of a (temporary) increase in seizure frequency as the participants actively
need to confront their most disturbing memories or scenarios. This can be a
trigger for seizures for some people with epilepsy. The participants will be
informed, and in case of a seizure occurring during therapy, the patient and
therapist will decide whether the session can continue. If the participant
feels that the sessions are too burdensome he or she can withdraw from the
study at any time. The ECG sensor is wearable and miniaturised, thus minimising
discomfort. In case of discomfort, the ECG sensor may be removed. Participants
in the treatment conditions are expected to benefit from study participation in
terms of reduced levels of anxiety and stress. We expect that their reduced
anxiety and stress level will lead to a decreased seizure frequency and
increased quality of life.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
-Diagnosis of definite epilepsy
-Epilepsy-related anxiety symptoms and/ or a diagnosis of (subtreshold) posttraumatic stress disorder (PTSD)
-18 years or older
Exclusion criteria
-The presence of psychological symptoms other than anxiety or PTSD in more urgent need of treatment (e.g. suicidal intent/acts or acute psychosis)
-Not able to read/write and communicate in the Dutch language
-Currently receiving another form of psychological treatment
-Presence of psychogenic non-epileptic seizures
-Estimated IQ <80
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL64820.058.18 |