Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

— CBT  

Official title:

Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048605
• Other study ID #: BSLTraining2
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Psycho-social CBT based training
Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.
• Unspecific group training
Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	AbbVie, Bangerter-Rhyner Foundation, Parkinson Schweiz

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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;7:1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Burden questionnaire for Patients with Parkinson's Disease (Belastungsfragebogen)	Questionnaire for measuring psychosocial problems, no official english translation available.	Before and after 9 weeks of training, after 6 month
Primary	Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)		Before and after 9 weeks of training, After 6-month
Secondary	Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)		Before and after 9 weeks training, after 6 month

External Links

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