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

April 4, 2024 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psycho-social (CBT) based training
Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006)
Behavioral: Psycho-social CBT based training
Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.
Placebo Comparator: Unspecific group training

Health Enhancement Program

The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)
Behavioral: Unspecific group training
Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion
Other Names:
  • Health Enhancement Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before and after 9 weeks of training, After 6-month

Secondary Outcome Measures

Outcome Measure
Time Frame
Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)
Time Frame: Before and after 9 weeks training, after 6 month
Before and after 9 weeks training, after 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden questionnaire for Patients with Parkinson's Disease (Belastungsfragebogen)
Time Frame: Before and after 9 weeks of training, after 6 month
Questionnaire for measuring psychosocial problems, no official english translation available.
Before and after 9 weeks of training, after 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

AbbVie
Parkinson Schweiz
Bangerter-Rhyner Foundation

Investigators

  • Principal Investigator: Peter Fuhr, Prof., University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimated)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSLTraining2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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