Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04672551
Status:
RECRUITING
Last Update Posted:
2022-06-29
First Post:
2020-04-19
Brief Title:
EMDR Treatment in PTSD Following Cardiac Events
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
EMDR Treatment in PTSD Following Cardiac Events
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMDR_PTSD_MI
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
Detailed Description:
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 cjj
-induced PTSD in a randomized controlled trialThe 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 andor 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 MINI 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 patients 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 ie CAPS scores will be blind to the subjects 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 ab
After the intervention week 12 procedures of assessment 2 related to primary and secondary endpoints ie 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 ie CAPS scores will be blind to the subjects treatment condition
Therefore the here proposed study aims at testing EMDR therapy in cjj
-induced PTSD in a randomized controlled trialThe 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 andor 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 MINI 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 patients 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 ie CAPS scores will be blind to the subjects 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 ab
After the intervention week 12 procedures of assessment 2 related to primary and secondary endpoints ie 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 ie CAPS scores will be blind to the subjects treatment condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None