Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02141568
Status:
TERMINATED
Last Update Posted:
2019-04-05
First Post:
2014-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009440', 'term': 'Neurasthenia'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Low patient compliance and dropout during the period defined for the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2014-05-15', 'studyFirstSubmitQcDate': '2014-05-15', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Related Quality of Life', 'timeFrame': '6 months', 'description': 'Changes in the Short Form 36 Health Survey (SF-36)'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': '12 months', 'description': 'Total cost associated with healthcare due to intervention'}, {'measure': 'Anxiety', 'timeFrame': '6 months', 'description': 'Changes in the State-Trait Anxiety Inventory (STAI)'}, {'measure': 'Depression', 'timeFrame': '6 months', 'description': 'Changes in the Patient Health Questionnaire 9 (PHQ-9)'}, {'measure': 'Catastrophization', 'timeFrame': '6 months', 'description': 'Changes in the Pain Catastrophization Scale (PCS)'}, {'measure': 'Locus of Control', 'timeFrame': '6 months', 'description': 'Changes in the Health Locus of Control Survey (H-LOC)'}, {'measure': 'Existence of Symptoms', 'timeFrame': '6 months', 'description': 'Changes in the Patient Health Questionnaire 15 (PHQ-15)'}, {'measure': 'Pain Symptoms and Functioning', 'timeFrame': '6 months', 'description': 'Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)'}, {'measure': 'Patient Satisfaction with Medical Care', 'timeFrame': '6 months', 'description': 'Changes in the Low Threshold Experience Survey (LTES)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cost-effective', 'Unexplained Medical Symptoms', 'Frequent Attenders'], 'conditions': ['Neurasthenia', 'Chronic Pain', 'Chronic Headache']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to check the medical efficacy and economic benefits of multidisciplinary care in patients with unexplained medical complaints and consume medical services frequently.', 'detailedDescription': 'Background:\n\nSomatic or "medically unexplained" symptoms and syndromes are common and are seen by physicians across almost every medical specialty. In many instances, these phenomena can cause a great deal of pain and frustration, restrict function and reduce patients\' quality of life. Despite their frequency and severity, medical personnel often experience a great deal of difficulty in coping with such complaints and patients may be shuttled from specialist to specialist, often with little or no symptomatic relief and at a great deal of expense to the medical system. Many researchers now believe that these seemingly unrelated and "unexplained" conditions in fact share common psycho-physiological mechanisms, such as being catalyzed as a result of trauma or excessive stress, being mediated by the limbic system and affecting inhibitory sensory pathways.\n\nPurpose of the study:\n\nTesting the efficacy and cost-efficiency of a holistic multidisciplinary treatment methodology for medically unexplained symptoms (MUS).\n\nStages of the Study:\n\nThe study wil lbe conducted via two arms:\n\n1. A reterospective study of patients attending the Functional Neurology clinic a Soroka UMC between the years 2014-2018 in which patient records will be obtained via the regional offices of Clalit Health Services and analyzed in order to learn the effects of mind-body therapies on health care utilization.\n2. A prospective study of new patients arriving at the "functional neurology" clinic at Soroka UMC. Members of the second arm will be asked if they would be willing to participate in the study by their neurologist. Participants who have agreed to join the study will fill out Self-report measures at the beginning of their treatment, at the end of treatment (3 months) and 6 months after the start of treatment and 12 months after the start of treatment.\n\nExpected Results\n\n1. A decrease in expense rates and use of medical services\n2. An increase in patient satisfaction\n3. An increase in patient-reported health and quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women\n* Age 18 or higher\n* Treated at the Functional Neurology clinic at Soroka UMC\n\nExclusion Criteria:\n\n* patients with chronic illness such as cancer, dialysis patients, or any other severe identified illness\n* patients who do not speak Hebrew\n* bedridden patients\n* Schizophrenia, dementia and other severe mental illness'}, 'identificationModule': {'nctId': 'NCT02141568', 'briefTitle': 'Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Effectiveness and Cost-Effectiveness Analysis of Mind-Body Interventions in a Multi-Disciplinary Clinic for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)', 'orgStudyIdInfo': {'id': 'SOR-016312-CTIL'}, 'secondaryIdInfos': [{'id': 'SCRC12014', 'type': 'OTHER', 'domain': 'Soroka Clinical Research Center (SCRC)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group for Prospective Study', 'description': 'Intervention: Medical and psychological treatment at the Soroka UMC "functional neurology" outpatient clinic. Treatment will be conducted by a multidisciplinary staff. Patients will undergo an initial meeting with a neurologist and afterwards will be directed to other members of the team (psychologist, physical therapist) on a case by case basis.', 'interventionNames': ['Other: Medical and Psychological treatment']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur'}], 'interventions': [{'name': 'Medical and Psychological treatment', 'type': 'OTHER', 'description': 'Medical and psychological treatment by the staff of the "functional neurology" clinic at Soroka UMC. This treatment will include an initial visit to the staff neurologist and further multidisciplinary treatment as per his decision (the team includes a psychologist and a physical therapist).', 'armGroupLabels': ['Intervention Group for Prospective Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Yacov Ezra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}