There is a lack of research on the efficacy of psychotherapy and especially EMDR in
clinical-induced PTSD. In the light of clinical-induced PTSD having different symptoms
than traditional PTSD, this lack of research is highly problematic. Specifically, the
unique symptom profile in clinical-induced PTSD related to the enduring somatic threat
model was not addressed in any of the studies targeting PTSD in cardiac patients. In this
regard, EMDR might be most promising: The EMDR protocol includes the assessment of body
sensations associated with the target event, which is followed by reprocessing. The
bilateral eye movements during reprocessing seem to have de-arousing effects and may
thereby interrupt the positive feedback loop between cardiovascular sensations and
anxiety-induced arousal as explained by the enduring somatic threat model. Hence, EMDR
might be more suitable in cardiac PTSD patients compared to treatment protocols that
motivates patients to keep focusing on the traumatic event such as Prolonged Exposure,
where higher emotional involvement seems to be related to a better outcome.
Therefore, the here proposed study aims at testing EMDR therapy in c,jj
-induced PTSD in a randomized controlled trial.The here proposed study aims at testing
EMDR therapy in ACS-induced PTSD in a randomized controlled trial. More specifically, the
efficacy of the standardized trauma-focused procedure in terms of a reduced PTSD symptom
level will be tested against a passive waitlist control group.
Intervention group:
The intervention group consists of 30 patients diagnosed with PTSD induced by cardiac
events. Eight individual EMDR sessions lasting for 1 hours will be provided over 8 weeks
by licensed EMDR therapists from the German-speaking part of Switzerland. Each EMDR
session follows a standardized 8-phase protocol. As Shapiro posits that it is necessary
to adapt the standard procedures to the unique needs and characteristics of the patient
and to apply different EMDR protocols for different pathologies, the therapy for cardiac
events was adapted from the standard protocol.
Waiting control group:
The intervention group consists of 30 patients diagnosed with PTSD induced by cardiac
events. No intervention or any other procedure will be conducted during the study period
of 36 weeks. Afterwards these subjects will be offered an EMDR therapy as provided in the
intervention.
Screening for inclusion and exclusion criteria prior to study inclusion:
After discharge, survivors of a cardiac event will be informed about the study by a
letter. The Screening will be conducted by phone and/or e-mail. Eligible participants
will be screened for inclusion and exclusion criteria. Screening for a probable PTSD
diagnosis will be conducted using Part III of the PCL-5 for DSM-5. Subjects who meet a
total sum score of 28 or more, will be invited for Baseline a.
Baseline a: Definitive inclusion, baseline measurements, randomization Assessment 1
consists of two appointments taking place at the University Hospital Zurich. During the
first appointment, the CAPS-5 and the M.I.N.I will be administered in order to ascertain
a PTSD and other psychiatric diagnoses. By means of the CAPS-5, it will be determined
whether the participants have PTSD (inclusion criterion and baseline assessment of
primary outcome).
As the assessment of the traumatic event during the interview can cause distress
(although only minimal and transient), which affects biomarkers, the assessment of
cardiovascular biomarkers and stress sensitization by means of the loud-tone procedure
will be carried out at a separate appointment.
The second appointment (Baseline b) will be scheduled within 7 days after the first
appointment to assess the baseline of all secondary endpoints: 1) saliva and blood
samples will be collected to obtain, stress hormones, and cardiovascular biomarkers,
including blood pressure; 2) the loud-tone procedure will be administered; 3) patient's
medication will be documented. Moreover, the following information will be obtained from
the potential participants or from hospital charts: Demographic factors, established
cardiovascular risk factors and life style behavior, objective indices of myocardial
damage and severity, variables related to patient referral to the coronary care unit,
recurrent cardiac symptoms, recurrent hospitalizations, cardiac rehabilitation, doctor
visits, pharmacological treatment, adherence to medication, medical comorbidities.
Psychometric data will be collected by means of questionnaires. These questionnaires will
be completed during the second appointment or from home via eCRF (Red Cap).
Randomization:
Participants will be randomized into either the intervention group (EMDR treatment) or
the wait-list control group. Assessors who ascertain the primary outcome variable, i.e.
CAPS scores, will be blind to the subject's treatment condition. Randomization will be
conducted by a person outside of the study team.
Intervention period:
After randomization, the intervention (EMDR therapy) will be carried.
Post Treatment and 6-months Follow-up (a/b):
After the intervention (week 12), procedures of assessment 2 related to primary and
secondary endpoints (i.e., CAPS, psychophysiological reactivity, psychometry, blood and
saliva sampling) will be repeated. In order to test whether the effects of EMDR-treatment
are long-lasting, measurements will be repeated at 6-months follow-up. Assessors who
ascertain the primary outcome variable, i.e. CAPS scores, will be blind to the subject's
treatment condition.