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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Psycho-social (CBT) based training

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

Group Type EXPERIMENTAL

Psycho-social CBT based training

Intervention Type BEHAVIORAL

Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.

Unspecific group training

Health Enhancement Program

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

Group Type PLACEBO_COMPARATOR

Unspecific group training

Intervention Type BEHAVIORAL

Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion

Interventions

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Psycho-social CBT based training

Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.

Intervention Type BEHAVIORAL

Unspecific group training

Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion

Intervention Type BEHAVIORAL

Other Intervention Names

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Health Enhancement Program

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No