The goal of the present study is to investigate whether the blockade of NA-transmission by beta-antagonist propranolol reduces the common EMDR effects (reduced vividness/emotionality of emotional memories) in order to find out if NA-release (evoked…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Geen aandoening: geneesmiddel wordt gebruikt om de onderliggende neurobiologische processen te onderzoeken van een therapie voor PTSD, namelijk EMDR
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The emotionality and vividness of recollected memories at pretest (baseline),
posttest (after medication intake and each experimental manipulation) and after
24 hour follow-up measured with corrugator EMG, HR, SC, a VAS for emotionality,
and a VAS for vividness.
Secondary outcome
Not applicable
Background summary
Eye Movement Desensitization and Reprocessing (EMDR) is a widely used,
effective psychological treatment for posttraumatic stress disorder (PTSD). Its
core intervention is that patients recall trauma memories while simultaneously
making lateral eye movements. It is largely unknown how EMDR works, however,
much evidence has been obtained for the working memory hypothesis. This
hypothesis comprises that both recalling traumatic memories and making eye
movements (EM) tax working memory (WM), which has limited capacity.
Simultaneously performing both tasks leads to a competition for WM, rendering
the traumatic memories less vivid and emotional. When memories are recollected
they re-enter a labile state and become malleable and, because of this, the
traumatic memory is overwritten by the memory that is blurred by EM.
Emotional material is better (re) consolidated than emotional neutral material,
i.e., it is prioritized and is (re) consolidated more vividly and in greater
detail. This is caused by the release of noradrenaline (NA). In EMDR emotional
material is recollected and reconsolidated. Therefore, EMDR might work because
of NA release, i.e., NA enhances the reconsolidation of the blurred emotional
memories.
Study objective
The goal of the present study is to investigate whether the blockade of
NA-transmission by beta-antagonist propranolol reduces the common EMDR effects
(reduced vividness/emotionality of emotional memories) in order to find out if
NA-release (evoked by the emotionality of the memories) plays an important role
in the blurring of traumatic memories during EMDR.
Study design
The proposed study will use a double-blind, placebo-controlled, experimental,
repeated measures design, with medication group (placebo, propranolol) as
between subjects independent variable, condition (recall + EM, recall only, no
recall) and time (pretest, posttest-1, posttest-2) as within subjects
independent variables, and VAS-rated vividness and emotional arousal, and
physiological response (heart rate, skin conductance and facial
electromyography (EMG)) as dependent variables.
Intervention
Half of the participants will receive 40 mg of the beta-blocker propranolol and
half will receive a placebo. Of the three memories participants have to
retrieve during the pretest (and will be scored on VASs), one will be recalled
while making EM (recall + EM), one without EM (recall only), and one will not
be retrieved (no recall) during the intervention. During the posttest all three
memories will be retrieved again and scored on vividness/emotionailty.
Study burden and risks
This project encompasses a low risk study. The low dosage (40 mg) of
propranolol has minimal side-effects (see SPC and IB for an overview), and
serious adverse events are very unlikely. Participants are carefully screened
for contraindicative conditions and medication use. Another burden for the
subjects is that they have to invest some time (approximately 5 hours) in
participating in the study. The burdens of the test can be justified by the
clinical and scientific relevance of the study. Skin conductance, heart rate,
and currugator EMG measures are non-invasive. Participants can withdraw at any
time from the study.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- Passing the medical screening (ECG, blood pressure and heart rate examination, two-step test and interview)
- Age 18-35
- BMI 17.5-26
- Normal (or corrected to normal) vision
- In females: the use of reliable contraceptives (birth control pills or a hormonal intrauterine device)
Exclusion criteria
Assessed with physical exam:
- Abnormal ECG
- Systolic blood pressure < 60mmHg; Diastolic blood pressure < 90 mmHg
- Heart rate < 60 bpm or > 100 bpm
- No <10% increase in heart rate after 1 minute of stepping up and down a stepladder.;Assesed with interview:
- Familiarity with EMDR and/or prior participation in EMDR research
- Lifetime history of psychiatric disorder (depression, mania, psychosis, anxiety)
- Lifetime history of neurological disease (attention/memory problems and disorders, epilepsy, convulsions)
- Lifetime history of any cardiovascular problem, coronary insufficiency, congestive heart failure, heart block, bradycardia, myocardial infarction, hypotension, chronic obstructive pulmonary disease, bronchial asthma, renal disorders, liver disorders, uraemia, hyperthyroidism, acidosis.
- Early age cardiovascular problems in first degree family members
- Fainting easily (can be indicative of cardiovascular problems).
- Inability to adequately read or speak Dutch
- Use of any contraindicative medication:
- Medication that decreases blood pressure, or cardiac contractility or conductivity
- Medication for migraine, dizziness, asthma, tuberculosis, psoriasis
- Medication that lowers blood sugar levels
- Anti-inflammatory painkillers
- Anti-depressives
- Anti-psychotics
- Anxiolytics
- Antacids
- Recreational drug use other than alcohol in the past 3 months
- Known sensitivity to propranolol
- Daily smoking (>=10 cigarettes per day)
- Excessive drinking (>=4 glasses per day)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2012-003901-90-NL |
CCMO | NL41743.041.12 |
OMON | NL-OMON22254 |