Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT06265194
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of EMDR in the Treatment of Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PARTICIPANT'], 'maskingDescription': 'Participants do not have the knowledge of group interventions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': '1-month and 3-month follow-up.', 'description': 'Patients with fibromyalgia pain who underwent the EMDR fibromyalgia protocol will exhibit greater improvement compared to the control group. The scores are between 0-4, and more scores mean worse results for the relevant items.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '1-month and 3-month follow-up.', 'description': 'The experimental group will show a significant reduction in sleep difficulties, and this improvement will persist in one-month and three-month follow-ups. The scores are between 0-3, and more scores mean worse results for the relevant items.'}, {'measure': 'Trauma Symptom Checklist-40 (TSC-40)', 'timeFrame': '1-month and 3-month follow-up.', 'description': 'Traumatic stress symptoms in fibromyalgia patients from the experimental group will significantly decrease after undergoing the EMDR Fibromyalgia Protocol. The scores are between 0-3, and more scores mean worse results for the relevant items.'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': '1-month and 3-month follow-up.', 'description': 'The EMDR Fibromyalgia Protocol used in the study is not designed for depression primarily, however, even in this case, the level of depression will be decreased in the experimental group. The scores are between 0-3, and more scores mean worse results for the relevant items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EMDR', 'RCT', 'Depression', 'Pain'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '38835548', 'type': 'DERIVED', 'citation': 'Zat Ciftci Z, Delibas DH, Kaya T, Kulcu DG, Sari A, Nazlikul H, Coskun Topsakal I, Aydin YE, Kavakci O, Savran C, Konuk E. A randomized controlled trial of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in the treatment of fibromyalgia. Front Psychiatry. 2024 May 21;15:1286118. doi: 10.3389/fpsyt.2024.1286118. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.\n\nThe main questions it aims to answer are:\n\n* Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?\n* Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?\n* Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia?', 'detailedDescription': "Background: In addition to pharmacological treatments, psychotherapeutic approaches are recommended for the treatment of fibromyalgia. There is a suggestion that Eye Movement Desensitization and Reprocessing (EMDR) therapy may be effective. This study aims to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients through a Randomized Controlled Study (RCT).\n\nMaterial and methods: The sample for this study comprises 79 individuals diagnosed with fibromyalgia. Participants were randomly assigned to two groups: the 'Treatment as Usual' (TAU) group and the TAU+EMDR group. Prior to the study and at six different time points (before starting the study, at the end of the 5th, 10th, and 15th sessions, 1 month later, and 3 months later), participants completed assessments, including the Fibromyalgia Impact Questionnaire (FIQ), Visual Analog Scale (VAS), Fibromyalgia ACR 2010 Diagnostic Criteria (Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Trauma Symptom Checklist-40 (TSC-40)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of fibromyalgia,\n2. Age between 18-65,\n3. Compliance with routine medical fibromyalgia treatment,\n4. Cognitive and technical competence to meet the working conditions,\n5. Volunteering to participate in the study.\n\nExclusion Criteria:\n\n1. Receiving any psychotherapy,\n2. Presence of psychiatric disorders such as Schizophrenia or Bipolar Affective Disorder, c) No other physical and psychological targets apart from trauma needing to be addressed before fibromyalgia pain (e.g., suicide, domestic violence, etc.),\n\nd) Presence of an organic cause that can cause pain.'}, 'identificationModule': {'nctId': 'NCT06265194', 'acronym': 'EMDR', 'briefTitle': 'Effect of EMDR in the Treatment of Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Academy of Therapeutic Sciences, Turkey'}, 'officialTitle': 'A Randomized Controlled Trial of Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Fibromyalgia', 'orgStudyIdInfo': {'id': 'ZAT2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (TAU and EMDR)', 'description': 'Intervention Group: Received TAU and EMDR Therapists delivering EMDR Therapy provided psychotherapeutic services to clients in the experimental group using the EMDR Fibromyalgia Treatment.', 'interventionNames': ['Behavioral: EMDR', 'Behavioral: TAU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control (TAU)', 'description': 'Control Group: TAU Routine fibromyalgia treatments, referred to as Treatment as Usual (TAU) in this study, were initiated in the outpatient clinic conditions. TAU are treatments designed by rheumatologists in accordance with current rheumatology guidelines.', 'interventionNames': ['Behavioral: TAU']}], 'interventions': [{'name': 'EMDR', 'type': 'BEHAVIORAL', 'description': 'The fibromyalgia protocol applied to the patients in the study was developed specifically for fibromyalgia by Konuk, and colleagues (Konuk et al.). In addition to the article, the details of the protocol and the study sheet are presented supplementary. After a short introduction, the participants were informed about the protocol, their -consent was obtained for registration, and a visual, tactile and audio bilateral stimulus that will be used in the application was introduced.', 'armGroupLabels': ['Intervention (TAU and EMDR)']}, {'name': 'TAU', 'type': 'BEHAVIORAL', 'description': 'Treatment as Usual (TAU): Routine fibromyalgia treatments, referred to as Treatment as Usual (TAU) in this study, were initiated in the outpatient clinic conditions. TAU are treatments designed by rheumatologists in accordance with current rheumatology guidelines.', 'armGroupLabels': ['Control (TAU)', 'Intervention (TAU and EMDR)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academy of Therapeutic Sciences, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}