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

University Hospital Basel

Status: Completed

Conditions: Mild Cognitive Impairment; Parkinson's Disease

Treatments: Behavioral: Psycho-social CBT based training; Behavioral: Unspecific group training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02048605

BSLTraining2

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 45 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Psycho-social (CBT) based training

Experimental group

Description:

Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006)

Treatment:

Behavioral: Psycho-social CBT based training

Unspecific group training

Placebo Comparator group

Description:

Health Enhancement Program The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012)

Treatment:

Behavioral: Unspecific group training