EMDR Therapy Following After a Myocardial Infarction Induced Posttraumatic Stress Disorder (EMDR_PTSD_MI)

• ClinicalTrials.gov Identifier: NCT04672551
• Recruitment Status: Recruiting
• First Posted: December 17, 2020
• Last Update Posted: March 12, 2021
• Sponsor: University of Zurich
• Collaborators: EMDR Europe; Stiftung zur Förderung von Psychiatrie und Psychotherapie; EMDR Foundation
• Information provided by (Responsible Party): University of Zurich

Study Description

Brief Summary:

Acute cardiac syndromes (ACS) can often result in debilitating and persistent psychological symptoms. A key question involves whether optimal treatment of ACS-induced posttraumatic stress disorder (PTSD) reduces PTSD symptoms and thereby may offset the risk of recurrent or worsening cardiovascular disease. ACS-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 ACS-induced PTSD. Currently, patients with ACS-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 ACS-induced PTSD.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder; Myocardial Infarction; Eye Movement Desensitization and Reprocessing	Behavioral: EMDR Treatment	Not Applicable

Detailed Description:

There is a lack of research on the efficacy of psychotherapy and especially EMDR in ACS-induced PTSD. In the light of ACS-induced PTSD having different symptoms than traditional PTSD, this lack of research is highly problematic. Specifically, the unique symptom profile in ACS-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 ACS-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 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. 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 ACS patients was adapted from the standard protocol.

Waiting control group:

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.

Screening for inclusion and exclusion criteria prior to study inclusion:

After discharge, survivors of an acute 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: EMDR Treatment in PTSD Following Acute Coronary Syndromes
• Actual Study Start Date: November 21, 2020
• Estimated Primary Completion Date: February 28, 2022
• Estimated Study Completion Date: February 28, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Waitlist control group; 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.
Experimental: Intervention group; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Interview-rated posttraumatic stress 3 months Follow-up [ Time Frame: 3 months ]
   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).
2. Interview-rated posttraumatic stress 6 months Follow-up [ Time Frame: 6 months ]
   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 Outcome Measures :

1. Nose-related psychophysiological stress responses - Heart Rate 3 months [ Time Frame: 3 months ]
   Heart rate (HR)
2. Nose-related psychophysiological stress responses - Skin Conductance 3 months [ Time Frame: 3 months ]
   skin conductance (SC) responses
3. Nose-related psychophysiological stress responses - Heart Rate Variability 3 months [ Time Frame: 3 months ]
   Heart rate variability (HRV)
4. Nose-related psychophysiological stress responses - Heart Rate 6 months [ Time Frame: 6 months ]
   Heart rate (HR)
5. Nose-related psychophysiological stress responses Skin Conductance - 6 months [ Time Frame: 6 months ]
   skin conductance (SC) responses
6. Nose-related psychophysiological stress responses - Heart Rate Variability - 6 months [ Time Frame: 6 months ]
   Heart rate variability (HRV)
7. Stress hormones - Plasma Norepinephrine 3 months [ Time Frame: 3 months ]
   Concentration of Plasma norepinephrine
8. Stress hormones - Epinephrine 3 months [ Time Frame: 3 months ]
   Concentration of Epinephrine
9. Stress hormones - Cortisol 3 months [ Time Frame: 3 months ]
   Concentration of Salivary Cortisol
10. Stress hormones - Plasma Norepinephrine - 6 months [ Time Frame: 6 months ]
    Concentration of Plasma norepinephrine
11. Stress hormones - Epinephrine 6 months [ Time Frame: 6 months ]
    Concentration of Epinephrine
12. Stress hormones - Salivary Cortisol 6 months [ Time Frame: 6 months ]
    Concentration of Salivary Cortisol
13. Cardiometabolic biomarkers - metabolic factors 3 months [ Time Frame: 3 months ]
    Metabolic Factors (Concentration of total cholesterol, low density lipoprotein (LDL-C), high density lipoprotein (HDL-C), triglycerides and glucose)
14. Cardiometabolic biomarkers - metabolic factors 6 months [ Time Frame: 6 months ]
    Metabolic Factors (Concentration of total cholesterol, low density lipoprotein (LDL-C), high density lipoprotein (HDL-C), triglycerides and glucose)
15. Cardiometabolic biomarkers - inflammation markers 3 months [ Time Frame: 3 months ]
    Inflammation markers (Concentration of high-sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha))
16. Cardiometabolic biomarkers - inflammation markers 6 months [ Time Frame: 6 months ]
    Inflammation markers (Concentration of high-sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha))

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Christoph Mueller-Pfeiffer, PD Dr. med.; +41 44 255 52 80; christoph.mueller-pfeiffer@access.uzh.ch

Contact: Mary Princip, PhD; +41 44 255 52 80; mary.princip@usz.ch

Locations

Switzerland

University Hospital Zurich; Recruiting

Zürich, Switzerland

Contact: Mary Princip

Sponsors and Collaborators

University of Zurich

EMDR Europe

Stiftung zur Förderung von Psychiatrie und Psychotherapie

EMDR Foundation

Investigators

• Principal Investigator: Christoph Mueller-Pfeiffer, PD Dr. med.; University of Zurich/University Hospital Zurich

More Information

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04672551
• Other Study ID Numbers: 2019-00817
• First Posted: December 17, 2020
• Last Update Posted: March 12, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:

PTSD; MI; ACS; EMDR

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Trauma and Stressor Related Disorders; Mental Disorders