Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease (CBT)
Primary Purpose
Parkinson's Disease, Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Psycho-social CBT based training
Unspecific group training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Psycho-social (CBT) based training
Unspecific group training
Arm Description
Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006)
Health Enhancement Program The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)
Outcomes
Primary Outcome Measures
Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)
Secondary Outcome Measures
Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)
Full Information
NCT ID
NCT02048605
First Posted
January 23, 2014
Last Updated
September 18, 2020
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Parkinson Schweiz, Bangerter-Rhyner Foundation, AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT02048605
Brief Title
Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease
Acronym
CBT
Official Title
Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Parkinson Schweiz, Bangerter-Rhyner Foundation, AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psycho-social (CBT) based training
Arm Type
Experimental
Arm Description
Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006)
Arm Title
Unspecific group training
Arm Type
Placebo Comparator
Arm Description
Health Enhancement Program
The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)
Intervention Type
Behavioral
Intervention Name(s)
Psycho-social CBT based training
Intervention Description
Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.
Intervention Type
Behavioral
Intervention Name(s)
Unspecific group training
Other Intervention Name(s)
Health Enhancement Program
Intervention Description
Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion
Primary Outcome Measure Information:
Title
Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)
Time Frame
Before and after 9 weeks of training, After 6-month
Secondary Outcome Measure Information:
Title
Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)
Time Frame
Before and after 9 weeks training, after 6 month
Other Pre-specified Outcome Measures:
Title
Burden questionnaire for Patients with Parkinson's Disease (Belastungsfragebogen)
Description
Questionnaire for measuring psychosocial problems, no official english translation available.
Time Frame
Before and after 9 weeks of training, after 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Fuhr, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
http://parkinson-team.ch/
Description
Click here for more information about this study
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Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease
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