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Completed

NCT Number: NCT02048605

Training of Psychosocial Skills Based on Cognitive Behavioural Therapy 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psycho-social CBT based training

Behavioral

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

Unspecific group training

Behavioral

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

Other names: Health Enhancement Program

Primary outcomes

  1. 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

  1. Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)

    Time frame: Before and after 9 weeks training, after 6 month

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • AbbVie
  • Bangerter-Rhyner Foundation
  • Parkinson Schweiz

Registry information

Official study title

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

Acronym: CBT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 29, 2014
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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