EMDR Treatment in PTSD Following Cardiac Events

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Zurich

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • EMDR Treatment

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Waitlist control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
3 months
2

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).

Time frame
6 months

Secondary outcomes

1

Nose-related psychophysiological stress responses - Heart Rate 3 months

Heart rate (HR)

Time frame
3 months
2

Nose-related psychophysiological stress responses - Skin Conductance 3 months

skin conductance (SC) responses

Time frame
3 months
3

Nose-related psychophysiological stress responses - Heart Rate Variability 3 months

Heart rate variability (HRV)

Time frame
3 months
4

Nose-related psychophysiological stress responses - Heart Rate 6 months

Heart rate (HR)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

EMDR Europe

Collaborator

Stiftung zur Förderung von Psychiatrie und Psychotherapie

Collaborator

EMDR Foundation

Collaborator

EMDO Stiftung

Collaborator