About this trial
Cardiac events can often result in debilitating and persistent psychological symptoms. A key question involves whether optimal treatment of cardiac-induced posttraumatic stress disorder (PTSD) reduces PTSD symptoms and thereby may offset the risk of recurrent or worsening cardiovascular disease. Cardiac-induced PTSD 1) is prevalent, 2) features symptoms unique to internal ongoing somatic threat, with fears and worries that can be distinguished from PTSD resulting from external causes, 3) is persistent, 4) is associated with negative physical and emotional consequences, and 5) has not been the subject of randomized-controlled treatment trials (RCT). There is preliminary evidence suggesting that patients with cardiac-disease induced PTSD might particularly profit from EMDR. Nevertheless, this possibility has not been tested in cardiac-induced PTSD. Currently, patients with cardiac-induced PTSD are not routinely offered trauma-focused therapies, with a lack of scientific evidence likely being one major reason for this omission. If our proposed RCT shows that EMDR can be an effective treatment for patients with ACS-induced PTSD, EMDR could be routinely implemented as first-line treatment. The RCT outcomes might inform larger trials to test whether poor prognosis in terms of major adverse cardiovascular events can be improved through EMDR in patients with cardiac-induced PTSD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-70 years
Men or women
STEMI (irrespective of troponin, but ST-elevation) or non-STEMI (troponin positive) at the time of the cardiac event, as verified by the cardiologist
Diagnosis of PTSD caused by the cardiac event
Disqualifiers
Psychotic disorder, bipolar disorder, substance abuse as measured with the Mini International Neuropsychiatric Interview (M.I.N.I)
Acute suicidal ideation as assessed with the M.I.N.I.
Non-selective beta blockers (e.g., propranolol) during the study period
Ongoing psychological/psychiatric treatment outside of the trial during the study period
Trial design
Parallel
Treatments tested in this trial
EMDR Treatment
BehavioralEight 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.
Treatment groups
Trial outcomes
Primary outcomes
Interview-rated posttraumatic stress 3 months Follow-up
The primary endpoint is the interviewer-rated posttraumatic stress level at three months follow-up (by means of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a range from 0-160, whereby higher scores mean a worse outcome).
Interview-rated posttraumatic stress 6 months Follow-up
The primary endpoint is the interviewer-rated posttraumatic stress level at six months follow-up (by means of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a range from 0-160, whereby higher scores mean a worse outcome).
Secondary outcomes
Nose-related psychophysiological stress responses - Heart Rate 3 months
Heart rate (HR)
Nose-related psychophysiological stress responses - Skin Conductance 3 months
skin conductance (SC) responses
Nose-related psychophysiological stress responses - Heart Rate Variability 3 months
Heart rate variability (HRV)
Nose-related psychophysiological stress responses - Heart Rate 6 months
Heart rate (HR)
Sponsors and contacts
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University of Zurich
Lead sponsor
EMDR Europe
Collaborator
Stiftung zur Förderung von Psychiatrie und Psychotherapie
Collaborator
EMDR Foundation
Collaborator
EMDO Stiftung
Collaborator