Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00360802
Status:
COMPLETED
Last Update Posted:
2009-05-28
First Post:
2006-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-27', 'studyFirstSubmitDate': '2006-08-04', 'studyFirstSubmitQcDate': '2006-08-04', 'lastUpdatePostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of improvement in: anxiety, quality of life', 'timeFrame': 'immediately after therapy, at 3 months, and at 12 months'}], 'secondaryOutcomes': [{'measure': 'Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received', 'timeFrame': 'immediately after therapy, at 3 months, and at 12 months'}]}, 'conditionsModule': {'keywords': ['chronic low back pain', 'cognitive-behavioral therapy', 'Mindful Based Stress Reduction', 'pain clinics', 'anxiety', 'quality of life', 'chronic pain'], 'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '11172169', 'type': 'BACKGROUND', 'citation': 'Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.'}, {'pmid': '11034658', 'type': 'BACKGROUND', 'citation': 'van Tulder MW, Ostelo R, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ. Behavioral treatment for chronic low back pain: a systematic review within the framework of the Cochrane Back Review Group. Spine (Phila Pa 1976). 2000 Oct 15;25(20):2688-99. doi: 10.1097/00007632-200010150-00024.'}, {'pmid': '9216352', 'type': 'BACKGROUND', 'citation': 'Basler HD, Jakle C, Kroner-Herwig B. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Patient Educ Couns. 1997 Jun;31(2):113-24. doi: 10.1016/s0738-3991(97)00996-8.'}, {'pmid': '21668743', 'type': 'DERIVED', 'citation': 'Moix J, Kovacs FM, Martin A, Plana MN, Royuela A; Spanish Back Pain Research Network. Catastrophizing, state anxiety, anger, and depressive symptoms do not correlate with disability when variations of trait anxiety are taken into account. a study of chronic low back pain patients treated in Spanish pain units [NCT00360802]. Pain Med. 2011 Jul;12(7):1008-17. doi: 10.1111/j.1526-4637.2011.01155.x. Epub 2011 Jun 13.'}], 'seeAlsoLinks': [{'url': 'http://www.reide.org', 'label': 'Spanish Back Pain Research Network site that describes objectives and projects of its members'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic low back pain and failed back surgery patients\n* With or without referred or radiated pain\n* Who are between 18 and 70 years of age (inclusive)\n\nExclusion Criteria:\n\n* Patients with red flags for systemic disease or criteria for surgery\n* With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment\n* With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis\n* Under psychological or psychiatric treatment\n* Unable to fill out the questionnaires\n* Have received cognitive behavioral treatment in the past\n* Have ongoing work litigation or are in the process of obtaining permanent disability.'}, 'identificationModule': {'nctId': 'NCT00360802', 'briefTitle': 'Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kovacs Foundation'}, 'officialTitle': 'The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics', 'orgStudyIdInfo': {'id': 'FK-FIS-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CBT', 'description': 'Cognitive Behavioral Treatment', 'interventionNames': ['Behavioral: Cognitive Behavioral Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MBSR', 'description': 'Mindfulness Based Stress Reduction', 'interventionNames': ['Behavioral: Mindfulness Based Stress Reduction']}], 'interventions': [{'name': 'Cognitive Behavioral Treatment', 'type': 'BEHAVIORAL', 'description': 'Behavioral treatment to reduce pain in chronic back pain patients', 'armGroupLabels': ['CBT']}, {'name': 'Mindfulness Based Stress Reduction', 'type': 'BEHAVIORAL', 'description': 'Behavioral treatment to reduce pain in chronic back pain patients', 'armGroupLabels': ['MBSR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08193', 'city': 'Bellaterra, Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación'}], 'overallOfficials': [{'name': 'Francisco M. Kovacs, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kovacs Foundation, Palma de Mallorca, 07012, Spain'}, {'name': 'Jenny Moix, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain'}, {'name': 'María José Martín', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Mutua de Terrasa, Terrasa 08221, Spain'}, {'name': 'María Angeles Pastor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital General y Universitario de Alicante, Alicante 03010, Spain'}, {'name': 'María Isabel Casado, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital 12 de Octubre, Madrid 28041, Soain'}, {'name': 'Carlos Peña, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain'}, {'name': 'Andrés Martín, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital de Son Llatzer, Palma de Mallorca 07198, Spain'}, {'name': 'Gema Rodríguez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Severo Ochoa, Leganés, Madrid 28911, Spain'}, {'name': 'Francisco Javier Cano, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla 41013, Spain'}, {'name': 'Milena Gobbo, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundación Hospital Alcorcón, Madrid 28922, Spain'}, {'name': 'Almudena Mateos, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundación Hospital Alcorcón, Madrid 28922, Spain'}, {'name': 'Carla Casals, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital de Figueres, Figueres 17600, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovacs Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Back Pain Research Network (REIDE)', 'class': 'OTHER'}, {'name': 'Fondo de Investigacion Sanitaria', 'class': 'OTHER'}, {'name': 'Universitat Autonoma de Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jenny Moix, Professor', 'oldOrganization': 'Universidad Autónoma de Barcelona'}}}}