EMDR Treatment in PTSD Following Cardiac Events

NCT04672551 | Recruiting

• 1 other identifier: 2019-00817
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Myocardial Infarction; Eye Movement Desensitization and Reprocessing

Keywords

PTSD; MI; ACS; EMDR

Outcome Measures

Primary Outcomes (2)

• 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).

  3 months

• 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).

  6 months

Secondary Outcomes (16)

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

  3 months

• Nose-related psychophysiological stress responses - Skin Conductance 3 months

  3 months

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

  3 months

• Nose-related psychophysiological stress responses - Heart Rate 6 months

  6 months

• Nose-related psychophysiological stress responses Skin Conductance - 6 months

  6 months

Study Arms (2)

Waitlist control group

NO INTERVENTION

The intervention group consists of 30 patients diagnosed with PTSD induced by ACS. 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.

Intervention group

EXPERIMENTAL

The intervention group consists of 30 patients diagnosed with PTSD induced by ACS. 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.

Behavioral: EMDR Treatment

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Visionary problems, e.g. strabismus, which does not allow adequate eye movements
• Insufficient knowledge of the German language
• Expected inability or willingness to follow the study protocol
• Regular medication with benzodiazepine

Sponsors & Collaborators

• EMDR Foundation: collaborator
• EMDO Stiftung: collaborator
• University of Zurich: lead
• EMDR Europe: collaborator
• Stiftung zur Förderung von Psychiatrie und Psychotherapie: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Myocardial Infarction

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Christoph Mueller-Pfeiffer, PD Dr. med.

  University of Zurich/University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Mueller-Pfeiffer, PD Dr. med.

CONTACT

+41 44 255 52 80; christoph.mueller-pfeiffer@access.uzh.ch

Mary Princip, PD Dr. phil.

CONTACT

+41 44 255 52 80; mary.princip@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. 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.

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: December 17, 2020
• Study Start: November 21, 2020
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)