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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Parkinson's Disease
• Interventions: Behavioral: Psycho-social CBT based training; Behavioral: Unspecific group training

• Registration Number: NCT02048605
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Study Start: 2014-02
• Primary Completion: 2016-01
• Study Completion: 2017-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psycho-social (CBT) based training	Psycho-social CBT based training	Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006)
Unspecific group training	Unspecific group training	Health Enhancement Program The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)

Primary Outcome Measures

Name	Time	Method
Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)	Before and after 9 weeks of training, After 6-month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland