This trial is active, not recruiting.

Conditions parkinson's disease, mild cognitive impairment
Treatments psycho-social cbt based training, unspecific group training
Sponsor University Hospital, Basel, Switzerland
Collaborator Parkinson Schweiz
Start date February 2014
End date January 2016
Trial size 40 participants
Trial identifier NCT02048605, BSLTraining2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Psycho-social Training in Neurological Diseases - Parkinson`s Disease ( Training according to Ellgring et al., 2006)
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)
Health Enhancement Program The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)
unspecific group training Health Enhancement Program
Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants from 45 years up to 95 years old.

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.

Additional Information

Official title Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease
Principal investigator Peter Fuhr, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.