Parkinson's DiseaseCBTNCT02048605
Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease
A study testing Psycho-social CBT based training and Unspecific group training in people with Parkinson's Disease and Mild Cognitive Impairment, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Parkinson's Disease, Mild Cognitive Impairment
- What is being tested?
- Psycho-social CBT based training and Unspecific group training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Basel Training Study II: Training of Psychosocial Skills 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.
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Being tested
- Psycho-social CBT based training, Unspecific group training
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-social CBT based trainingBehavioural
Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.
Unspecific group trainingBehavioural
Also called Health Enhancement Program
Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion
| Study group | Role | What they receive |
|---|---|---|
| Psycho-social (CBT) based training | Experimental | Psycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006) Receives: 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) Receives: Behavioral: Unspecific group training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)
Measured: 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)
Measured: Before and after 9 weeks training, after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson Schweiz, Bangerter-Rhyner Foundation, AbbVie
- Responsible party
- Sponsor
- Investigators
- Peter Fuhr, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048605
- Sponsor's protocol ID
- BSLTraining2
- Acronym
- CBT
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2014
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28101066
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02048605
- Acronym / sponsor ID
- CBT / BSLTraining2
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Parkinson Schweiz, Bangerter-Rhyner Foundation, AbbVie
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psycho-social (CBT) based training | Experimental | Behavioral: Psycho-social CBT based trainingPsycho-social Training in Neurological Diseases - Parkinson's Disease ( Training according to Ellgring et al., 2006) |
| Unspecific group training | Placebo comparator | Behavioral: Unspecific group trainingHealth Enhancement Program The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR) (MacCoon et al., 2012) |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-social CBT based trainingNumber of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life. | Behavioural | Psycho-social (CBT) based training |
| Unspecific group trainingAlso: Health Enhancement ProgramNumber of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion | Behavioural | Unspecific group training |
Primary outcome
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
1 secondary outcome
Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)
Time frame: Before and after 9 weeks training, after 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Results publication: PubMed 28101066Hadinia 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.
- Click here for more information about this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Fuhr, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-social CBT based training and Unspecific group training in people with Parkinson's Disease and Mild Cognitive Impairment, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.