Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-27 @ 9:09 PM
Study NCT ID:
NCT01329861
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2011-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Cognitive Behavioural Treatment for Chronic Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coping Strategies Questionnaire - catastrophizing subscale (CSQ)', 'timeFrame': 'Two weeks pre treatment to two weeks post treatment', 'description': 'Change from baseline in the catastrophizing subscale to two weeks post treatment.'}], 'secondaryOutcomes': [{'measure': 'Multidimensional Pain Inventory (MPI)', 'timeFrame': 'Change from baseline Two weeks pre treatment to two weeks post treatment', 'description': 'MPI, assess psychosocial and behavioural consequences of pain. It´s divided into 2 sections and consisting of 8 scales. These are: Pain Severity, Interference, Life Control, Affective Distress, Support, Punishing Responses, Solicitous Responses and Distracting Responses.'}, {'measure': 'Pain and Impairment Relationship Scale (PAIRS)', 'timeFrame': 'Change from baseline Two weeks pre treatment to two weeks post treatment.', 'description': 'The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.'}, {'measure': 'Hospital Anxiety and Depression Scale(HADS).', 'timeFrame': 'Change from baseline Two weeks pre treatment to two weeks post treatment.', 'description': 'HADS is designed to measure anxiety and depression in non-psychiatric patients treated at hospital clinics.'}, {'measure': 'Quality of Life Inventory (QOLI)', 'timeFrame': 'Change from baseline Two weeks pre treatment to two weeks post treatment.', 'description': 'The assessment yields an overall score and profile for 16 areas of life: health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighbourhood and community.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic back pain', 'internet based treatment', 'pain management programme', 'cognitive behavioural therapy', 'minimal therapist contact'], 'conditions': ['Back Pain Lower Back Chronic']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate whether an Internet-based cognitive behavioural intervention would have an effect on the symptoms of chronic back pain.', 'detailedDescription': 'All participants were screened in a live, structured interview before inclusion. It´s a experimental design with a treatment and a control group measured before and after a treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18-65 years\n* access to the Internet\n* having been in contact with a physician\n* back pain of chronic nature\n* in current employment or on short-term sick leave(not longer than 6 months)\n\nExclusion Criteria:\n\n* wheelchair user\n* surgical treatment planned\n* history of cardiovascular treatment\n* severe depression'}, 'identificationModule': {'nctId': 'NCT01329861', 'briefTitle': 'Internet-based Cognitive Behavioural Treatment for Chronic Back Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Guided Internet-based Cognitive Behavioural Treatment for Chronic Back Pain Reduces Catastrophizing:a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'smarta2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet delivered CBT', 'description': 'Internet delivered cognitive behavioral intervention, 8 weeks treatment.', 'interventionNames': ['Behavioral: Guided Internet-based cognitive behavioural treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control condition', 'description': 'Wait-list condition, received treatment after post-treatment assessment.'}], 'interventions': [{'name': 'Guided Internet-based cognitive behavioural treatment', 'type': 'BEHAVIORAL', 'description': 'Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.', 'armGroupLabels': ['Internet delivered CBT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Gerhard Andersson, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linkoeping University'}, {'name': 'Monica Buhrman, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}, {'name': 'Elisabeth Nilsson-Ihrfelt, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Uppsala University'}, {'name': 'Maria Jannert, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Linkoeping University'}, {'name': 'Lars Ström, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Livanda (private practice) Västerås'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gerhard Andersson, professor', 'oldOrganization': 'Linkoeping University'}}}}