NCT02048605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

January 23, 2014

Last Update Submit

April 4, 2024

Conditions

Parkinson's DiseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)

    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)

    Before and after 9 weeks training, after 6 month

Other Outcomes (1)

  • Burden questionnaire for Patients with Parkinson's Disease (Belastungsfragebogen)

    Before and after 9 weeks of training, after 6 month

Study Arms (2)

Psycho-social (CBT) based training

EXPERIMENTAL

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

Behavioral: Psycho-social CBT based training

Unspecific group training

PLACEBO COMPARATOR

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

Behavioral: Unspecific group training

Interventions

Psycho-social CBT based trainingBEHAVIORAL

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

Psycho-social (CBT) based training
Unspecific group trainingBEHAVIORAL

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

Also known as: Health Enhancement Program
Unspecific group training

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Hadinia A, Meyer A, Bruegger V, Hatz F, Nowak K, Taub E, Nyberg E, Stieglitz RD, Fuhr P, Gschwandtner U. Cognitive Behavioral Group Therapy Reduces Stress and Improves the Quality of Life in Patients with Parkinson's Disease. Front Psychol. 2017 Jan 4;7:1975. doi: 10.3389/fpsyg.2016.01975. eCollection 2016.

    PMID: 28101066RESULT

Related Links

MeSH Terms

Conditions

Parkinson DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Peter Fuhr, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 29, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations

CH(1)