Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT06174051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flashforward EMDR Treatment for Patients With an ICD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study will have an open label, since the care provider (the psychologist) needs to know which procedure to follow and the participants will understand in which group they are once the therapy start.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this study, three groups are compared in a parallel setting. One group will receive EMDR following the flashforward procedure, one group will receive EMDR following the flashback procedure, and the last group will be on a wait list and fill out the questionnaires without receiving EMDR treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Life Events Checklist (LEC-5)', 'timeFrame': 'Baseline (Before treatment T0)', 'description': 'Self-report questionnaire to obtain information on previous traumatic life events'}], 'primaryOutcomes': [{'measure': 'Cardiac Anxiety Questionnaire (CAQ)', 'timeFrame': 'Baseline (Before treatment T0), after the first treatment session T1(for wait list after 2 weeks), and after the second treatment session T2 (for wait list after 4 weeks)', 'description': 'Self-report questionnaire to asses heart focussed anxiety'}], 'secondaryOutcomes': [{'measure': 'PTSD Check-List (PCL-5)', 'timeFrame': 'Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)', 'description': 'Self-report questionnaire to examine PTSD symptoms'}, {'measure': 'General Anxiety Questionnaire (GAD-7)', 'timeFrame': 'Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)', 'description': 'Self-report questionnaire to examine general anxiety symptoms'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)', 'description': 'Self-report questionnaire to examine depression symptoms'}, {'measure': 'EuroQol (EQ5D-5L)', 'timeFrame': 'Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)', 'description': 'Self-report questionnaire to examine quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EMDR', 'Flashforward', 'Anxiety', 'ICD'], 'conditions': ['Anxiety and Fear']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in patients with an implantable cardioverter defibrillator (ICD). Participants will fill out several questionnaires to asses their level of anxiety, depression symptoms and quality of life before, during and after treatment.', 'detailedDescription': 'Patients with an implantable cardioverter defibrillator (ICD) are at risk of ventricular arrhythmias (VA). The ICD is a device that can treat VA by antitachycardia pacing or ICD shocks. Since ICD shocks are painful and unpredictable, patients with an ICD can suffer from anxiety symptoms. Eye movement desensitization and reprocessing treatment (EMDR) is an effective treatment to enhance the process of traumatic events. In addition, this treatment has also shown to be able to reduce anxiety symptoms. EMDR treatment according to standard protocol starts with flashback (FB) procedure and may be followed by the flashforward (FF) procedure. The FB procedure focusses on events that happened in the past, while the FF procedure aims to reduce fear evoked by images of imagined future adverse events. So far, it is not clear whether the FB procedure is always necessary for the EMDR treatment to be effective. Moving straight towards application of the FF procedure (without first applying the FB procedure), may save treatment time and costs. Therefore, the main objective in this study is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in ICD patients. This will be tested with a pilot randomized controlled trial with a three-arm repeated measures design. Subjects will either receive FF EMDR, FB EMDR or no EMDR during the study. To measure their heart focussed anxiety, subjects will fill out the Cardiac Anxiety Questionnaire (CAQ) before, during and after treatment or waiting period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects have an ICD;\n* subjects have clinical anxiety symptoms related to their ICD.\n\nExclusion Criteria:\n\n* insufficient knowledge on Dutch or English language;\n* severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders'}, 'identificationModule': {'nctId': 'NCT06174051', 'acronym': 'eFFective', 'briefTitle': 'Flashforward EMDR Treatment for Patients With an ICD', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'The Effectiveness of Flashforward EMDR Treatment for Patients With an ICD', 'orgStudyIdInfo': {'id': '85546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FF EMDR', 'description': 'Subjects in this group will receive two EMDR treatment sessions following the flashforward protocol.', 'interventionNames': ['Behavioral: Flashforward EMDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FB EMDR', 'description': 'Subjects in this group will receive two EMDR treatment sessions following the flashback protocol.', 'interventionNames': ['Behavioral: Flashback EMDR']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Subjects in this group will not receive any treatment until the wait list period (4 weeks) is over'}], 'interventions': [{'name': 'Flashforward EMDR', 'type': 'BEHAVIORAL', 'description': 'The Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events.', 'armGroupLabels': ['FF EMDR']}, {'name': 'Flashback EMDR', 'type': 'BEHAVIORAL', 'description': 'The Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past.', 'armGroupLabels': ['FB EMDR']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Leonieke Kranenburg, PhD', 'role': 'CONTACT', 'email': 'l.kranenburg@erasmusmc.nl', 'phone': '+31654276606'}, {'name': 'Jan Busschbach, PhD', 'role': 'CONTACT', 'email': 'j.vanbusschbach@erasmusmc.nl', 'phone': '+31681423366'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available, anonymized, to other researchers, upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Leonieke Kranenburg', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}