Parkinson's DiseaseResPsyParkNCT05919628
Psychological Ressources, Anxiodepressive Symptoms, Well-being and Therapeutical Observance in Parkinson's Disease
An observational study of Parkinson's Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Anxiodepressive symptoms are frequently observed in Parkinson's disease patients. These non motor psychiatric charateristics of the disease negatively impairs quality of life, and may impair well-being or therapeutical observance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ResPsyPark group
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2023to 30 Jun 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parkinson's disease patients at any stage of the disease.
Who may be able to join
- Patients with diagnosis of Parkinson's disease
Who cannot join
- Patients with any other parkinsonian syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Ressources as a Protective Factor for Anxiety-depression, Well-being and Therapeutical Observance in Parkinson's Disease.
Anxiodepressive symptoms are frequently observed in Parkinson's disease patients. These non motor psychiatric charateristics of the disease negatively impairs quality of life, and may impair well-being or therapeutical observance.
The objective of this study is to determine if psychological ressources are associated to anxiodepressive symptoms, to parkinson well-being and therapeutical observance. It will be interesting to determine if the presence of some - or multiple- psychological ressources could prevent patients from anxiety, depression, impaired well-being and impaired observance.
Read more
This study will analyse retrospectively psychological scalescompleted by 30 parkinson's disease patients through previous psychological interviews. The scales investigate anxiety, depression, well-being, psychological ressources, and therapeutical observance.
The results will highlight the importance of working on psychological ressources with Parkinson's disease patients through psychotherapy, in order to improve their well-being, positive emotions and maybe contribute to better therapeutical observance.
Read the detailed description
The scales used are :
- The SPANE
- The PAS
- The LOT-R
- The SCS
- The brief BDI
- The SSAM
- The HAD
- The MAAS
- An observance scale
- Conditions
- Parkinson's Disease
- Being tested
- ResPsyPark group
- Keywords
- psychological ressources, well-being, depression, anxiety, therapeutical observance, parkinson's disease
- Medical subject headings
- Parkinson Disease, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResPsyPark groupOther
Evaluation of the parkinson's disease patient's score over different psychological questionnaires and a therapeutical observance questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the links between psychological ressources and anxiodepressive symptoms
Correlation and regression analysis between scores at the scales evaluating anxiety (PAS, HAD) and depression (BDI, HAD), and scores at the scales evaluating psychological ressources (LOT-R, SCS, SSAm, MAAS).
Measured: At baseline
Secondary outcomes (1)
Study of the links between therapeutical observance and anxiodepressive symptoms
Correlation and regression analysis between scores at the scales evaluating anxiety (PAS, HAD) and depression (BDI, HAD), and score at the scale evaluating therapeutical observance (%).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mme Mylène MEYER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919628
- Sponsor's protocol ID
- 2023PI077
- Acronym
- ResPsyPark
- Status last verified
- Sep 2023
- First submitted
- 19 May 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Ressources as a Protective Factor for Anxiety-depression, Well-being and Therapeutical Observance in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05919628
- Acronym / sponsor ID
- ResPsyPark / 2023PI077
- Conditions
- Parkinson's Disease
- Keywords
- psychological ressources, well-being, depression, anxiety, therapeutical observance, parkinson's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jun 2023 (actual)
- 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.
Anxiodepressive symptoms are frequently observed in Parkinson's disease patients. These non motor psychiatric charateristics of the disease negatively impairs quality of life, and may impair well-being or therapeutical observance.
The objective of this study is to determine if psychological ressources are associated to anxiodepressive symptoms, to parkinson well-being and therapeutical observance. It will be interesting to determine if the presence of some - or multiple- psychological ressources could prevent patients from anxiety, depression, impaired well-being and impaired observance.
This study will analyse retrospectively psychological scalescompleted by 30 parkinson's disease patients through previous psychological interviews. The scales investigate anxiety, depression, well-being, psychological ressources, and therapeutical observance.
The results will highlight the importance of working on psychological ressources with Parkinson's disease patients through psychotherapy, in order to improve their well-being, positive emotions and maybe contribute to better therapeutical observance.
Detailed description
The scales used are :
- The SPANE
- The PAS
- The LOT-R
- The SCS
- The brief BDI
- The SSAM
- The HAD
- The MAAS
- An observance scale
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parkinson's disease patients at any stage of the disease.
Key inclusion criteria (1 listed)
- Patients with diagnosis of Parkinson's disease
Key exclusion criteria (1 listed)
- Patients with any other parkinsonian syndrome
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 |
|---|---|---|
| ResPsyPark groupEvaluation of the parkinson's disease patient's score over different psychological questionnaires and a therapeutical observance questionnaire | Other | – |
Primary outcome
Study of the links between psychological ressources and anxiodepressive symptoms
Time frame: At baseline
Correlation and regression analysis between scores at the scales evaluating anxiety (PAS, HAD) and depression (BDI, HAD), and scores at the scales evaluating psychological ressources (LOT-R, SCS, SSAm, MAAS).
1 secondary outcome
Study of the links between therapeutical observance and anxiodepressive symptoms
Time frame: At baseline
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 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Central Hospital, Nancy, France at 1 site in France.
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 6 Sep 2023. 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 France. 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. 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?
Study of the links between psychological ressources and anxiodepressive symptoms (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.