Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-26 @ 7:33 PM
Study NCT ID:
NCT02237105
Status:
UNKNOWN
Last Update Posted:
2016-03-15
First Post:
2014-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2014-06-08', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BSI questionnaire in spine preoperative patients .', 'timeFrame': '24 months', 'description': 'assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire'}, {'measure': 'OSWESTRY questionnaire in spine preoperative patients', 'timeFrame': '24 months', 'description': 'Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire'}, {'measure': 'SF 36 questionnaire in spine preoperative patients', 'timeFrame': '24 months', 'description': 'assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire'}, {'measure': 'VAS scale in spine preoperative patients', 'timeFrame': '24 months', 'description': 'Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale'}], 'secondaryOutcomes': [{'measure': 'BSI questionnaire in spine postoperative patients', 'timeFrame': '24 months', 'description': 'assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire'}, {'measure': 'OSWESTRY questionnaire in spine postoperative patients', 'timeFrame': '24 months', 'description': 'Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire'}, {'measure': 'SF 36 questionnaire in postoperative patients', 'timeFrame': '24 months', 'description': 'Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire'}, {'measure': 'VAS scale in spine postoperative patients', 'timeFrame': '24 months', 'description': 'Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the outcome of spinal surgery.\n\nThe goal of this treatment is to change the coping style, thoughts, behavior and adaptive perception of the patient, and to replace them with an adaptive style.\n\nThe patients in this study will be randomly divided into two groups. One group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a control group, and will not have any psychological intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who intended to undergo spinal surgery\n\nExclusion Criteria:\n\n* patients who does not speak Hebrew language'}, 'identificationModule': {'nctId': 'NCT02237105', 'briefTitle': 'The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery', 'orgStudyIdInfo': {'id': 'MMC14276-13CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy Group', 'description': 'This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'This group will not undergo any psychological intervention before the spinal surgery.'}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy', 'armGroupLabels': ['Cognitive Behavioral Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shushan Amir', 'role': 'CONTACT', 'email': 'linor.amir@clalit.org.il', 'phone': '09-7472966'}, {'name': 'Linor Shushan Amir, MA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Meir MC', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}