Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06110702
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057169', 'term': 'Eye Movement Desensitization Reprocessing'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-28', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Traumatic Stress Symptoms - Pre-intervention', 'timeFrame': 'IES-R is measured immediately before the 8-week EMDR intervention', 'description': 'Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome'}, {'measure': 'Obsessive-Compulsive Symptoms - Pre-intervention', 'timeFrame': 'DOCS is measured immediately before the 8-week EMDR intervention', 'description': 'Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome'}, {'measure': 'Body Perception - Pre-intervention', 'timeFrame': 'BPQ-22 is measured immediately before the 8-week EMDR intervention', 'description': 'Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome'}, {'measure': 'Guilt and Shame - Pre-intervention', 'timeFrame': 'GASP is measured immediately before the 8-week EMDR intervention', 'description': 'Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome'}, {'measure': 'Disgust - Pre-intervention', 'timeFrame': 'TDDS is measured immediately before the 8-week EMDR intervention', 'description': 'Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome'}, {'measure': 'Mental Contamination - Pre-intervention', 'timeFrame': 'VOCI-MC is measured immediately before the 8-week EMDR intervention', 'description': 'Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome'}, {'measure': 'Post-Traumatic Stress Symptoms - Post-intervention', 'timeFrame': 'IES-R is measured immediately after the 8-week EMDR intervention', 'description': 'Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome'}, {'measure': 'Obsessive-Compulsive Symptoms - Post-intervention', 'timeFrame': 'DOCS is measured immediately after the 8-week EMDR intervention', 'description': 'Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome'}, {'measure': 'Body Perception - Post-intervention', 'timeFrame': 'BPQ-22 is measured immediately after the 8-week EMDR intervention', 'description': 'Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome'}, {'measure': 'Guilt and Shame - Post-intervention', 'timeFrame': 'GASP is measured immediately after the 8-week EMDR intervention', 'description': 'Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome'}, {'measure': 'Disgust - Post-intervention', 'timeFrame': 'TDDS is measured immediately after the 8-week EMDR intervention', 'description': 'Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome'}, {'measure': 'Mental Contamination - Post-intervention', 'timeFrame': 'VOCI-MC is measured immediately after the 8-week EMDR intervention', 'description': 'Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome'}], 'secondaryOutcomes': [{'measure': 'Anxiety Symptoms - Pre-intervention', 'timeFrame': 'DASS-21 is measured immediately before the 8-week EMDR intervention', 'description': 'Anxiety symptoms are measured using the Depression Anxiety Stress Scales (DASS-21).The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome'}, {'measure': 'Depression Symptoms - Pre-intervention', 'timeFrame': 'DASS-21 is measured immediately before the 8-week EMDR intervention', 'description': 'Depression symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome'}, {'measure': 'General distress symptoms - Pre-intervention', 'timeFrame': 'DASS-21 is measured immediately before the 8-week EMDR intervention', 'description': 'General distress symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome'}, {'measure': 'Anxiety Symptoms - Post-intervention', 'timeFrame': 'DASS-21 is measured immediately after the 8-week EMDR intervention', 'description': 'Anxiety symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome'}, {'measure': 'Depression Symptoms - Post-intervention', 'timeFrame': 'DASS-21 is measured immediately after the 8-week EMDR intervention', 'description': 'Depression symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome'}, {'measure': 'General distress symptoms - Post-intervention', 'timeFrame': 'DASS-21 is measured immediately after the 8-week EMDR intervention', 'description': 'General distress symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'OCD', 'Disgust', 'Guilt', 'Shame', 'Body', 'EMDR'], 'conditions': ['Adult ALL', 'Post-traumatic Stress Disorder', 'Obsessive-Compulsive Disorder', 'Disgust', 'Guilt', 'Shame']}, 'referencesModule': {'references': [{'pmid': '38988736', 'type': 'DERIVED', 'citation': 'Miccoli M, Poli A. Randomized trial on the effects of an EMDR intervention on traumatic and obsessive symptoms during the COVID-19 quarantine: a psychometric study. Front Psychiatry. 2024 Jun 26;15:1369216. doi: 10.3389/fpsyt.2024.1369216. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by Francine Shapiro in 1987 and can be adapted for online and in presence administration. The aim of this study is to assess if a EMDR program (administered both online and in presence, depending on different conditions of patients) may help people recruited from general population suffering from COVID19 second (November 2021 to February 2022) and third (March 2022 to May 2022) quarantine in improving post-traumatic stress (PTSD) and obsessive-compulsive-related (OCD) symptoms, as well as disgust, guilt, shame and their subjective unit of distress (SUD) and validity of cognition (VoC) levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants aged 18 to 75 years\n2. Participants experienced a full COVID19 pandemic-related quarantine during red zones of the second and third lockdowns in Italy\n3. Participants have reasonable comprehension of spoken and written Italian language\n4. Participants have an adequate understanding of Italian\n\nExclusion Criteria:\n\n1. Concurrent enrollment in other intervention trials\n2. Participants that already experienced EMDR therapy in the past'}, 'identificationModule': {'nctId': 'NCT06110702', 'acronym': 'MDL', 'briefTitle': 'Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study', 'orgStudyIdInfo': {'id': 'MDL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '8-week EMDR Intervention', 'description': "Phase 1: The therapist and client develop a secure working relationship. The client's history is discussed and a treatment plan is developed.\n\nPhase 2: The therapist explains the EMDR therapy process. Phase 3: The target event is identified. Baseline measures are set using the Subjective Units of Disturbance (SUD) and the Validity of Cognition (VOC) scale.\n\nPhase 4: Desensitization, sounds, or taps are begun while focusing on the traumatic event until the client's SUD reduces to zero.\n\nPhase 5: The client associates and strengthens a positive belief with the target event until it feels true.\n\nPhase 6: The client is asked to hold in mind the target event and the positive belief while scanning the body.\n\nPhase 7: Reprocessing is complete when the client feels neutral about it (SUD=0, VOC=7), and the body is clear of disturbance.\n\nPhase 8: The client and therapist discuss processed memories to ensure that distress is low and that the positive cognition is strong.", 'interventionNames': ['Behavioral: EMDR']}, {'type': 'NO_INTERVENTION', 'label': 'Control condition - No intervention', 'description': 'The control group will follow routine daily activities'}], 'interventions': [{'name': 'EMDR', 'type': 'BEHAVIORAL', 'description': 'Eye movement Desensitization and Reprocessing (as described in the 8-phases protocol), administered both online or in presence.', 'armGroupLabels': ['8-week EMDR Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'University of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Andrea Poli, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pisa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Raw data are available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Andrea Poli', 'investigatorAffiliation': 'University of Pisa'}}}}