Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02048605
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Burden questionnaire for Patients with Parkinson's Disease (Belastungsfragebogen)", 'timeFrame': 'Before and after 9 weeks of training, after 6 month', 'description': 'Questionnaire for measuring psychosocial problems, no official english translation available.'}], 'primaryOutcomes': [{'measure': 'Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)', 'timeFrame': 'Before and after 9 weeks of training, After 6-month'}], 'secondaryOutcomes': [{'measure': 'Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)', 'timeFrame': 'Before and after 9 weeks training, after 6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease", 'Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '28101066', 'type': 'RESULT', 'citation': "Hadinia A, Meyer A, Bruegger V, Hatz F, Nowak K, Taub E, Nyberg E, Stieglitz RD, Fuhr P, Gschwandtner U. Cognitive Behavioral Group Therapy Reduces Stress and Improves the Quality of Life in Patients with Parkinson's Disease. Front Psychol. 2017 Jan 4;7:1975. doi: 10.3389/fpsyg.2016.01975. eCollection 2016."}], 'seeAlsoLinks': [{'url': 'http://parkinson-team.ch/', 'label': 'Click here for more information about this study'}]}, 'descriptionModule': {'briefSummary': "Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral group-training-program to reduce stress and augment quality of life. An unspecific group with the same amount and frequency of meetings is used as a control group. For the evaluation of the training effects, scales to assess quality of life, analyses of psychopathological variations as well as neurocognitive tests will be used. Protocol amendment in 1-2017: addition of FU year 3 and year 5."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with idiopathic Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria, being either cognitively normal, suffering from Mild Cognitive Impairment or having mild dementia. Patients must be able to give their written informed consent.\n\nExclusion Criteria:\n\n* Moderate or severe dementia (DMS-IV, Mini Mental Status (MMS) \\<24), other neurological or psychiatric diseases of the brain not related to PD, secondary parkinsonism, physical impairment hindering the adequate execution of the training, insufficient knowledge of German or pregnancy are exclusion criteria. Deep Brain Stimulation (DBS) is no exclusion criterion."}, 'identificationModule': {'nctId': 'NCT02048605', 'acronym': 'CBT', 'briefTitle': "Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': "Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'BSLTraining2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psycho-social (CBT) based training', 'description': "Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006)", 'interventionNames': ['Behavioral: Psycho-social CBT based training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Unspecific group training', 'description': 'Health Enhancement Program\n\nThe validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)', 'interventionNames': ['Behavioral: Unspecific group training']}], 'interventions': [{'name': 'Psycho-social CBT based training', 'type': 'BEHAVIORAL', 'description': 'Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.', 'armGroupLabels': ['Psycho-social (CBT) based training']}, {'name': 'Unspecific group training', 'type': 'BEHAVIORAL', 'otherNames': ['Health Enhancement Program'], 'description': 'Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion', 'armGroupLabels': ['Unspecific group training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Peter Fuhr, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parkinson Schweiz', 'class': 'OTHER'}, {'name': 'Bangerter-Rhyner Foundation', 'class': 'UNKNOWN'}, {'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}