- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02824367
Evaluation of Clinical Perfectionism in Parkinson Disease (EPMP-1)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety. Also, clinicians reported that they exhibit specific personality traits (e.g., rigidity and perfectionism).
To date, few studies used Cognitive Behavioural Therapies (CBT) in people with Parkinson's disease showing promising results. Recently, perfectionism has received particular attention because of it association with many emotional disorders. Thus, some psychometric tools have been developed in order to evaluate different aspects of perfectionism. Yet, none of them has been used in people with Parkinson's disease.
The objective of this study is to investigate whether there is a direct link between Parkinson's disease and perfectionism by using psychometric tools from the CBT literature. Identifying such link would allow to justify the use of CBT in people with Parkinson's disease with the goal in mind to improve their care and quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age greater than 18 years
- Score Mini Mental Scale (MMS) greater than 23
- For Parkinsonian, Parkinson disease be defined according to the criteria of the Unified Parkinson Disease Rating Scale (UPDRS), with a Hoehn and Yahr stage 1, 2 or 3
- The control patients present dystonias not within the scope of Parkinson
- Informed Consent Form signed
- Patient covered by social insurance
Exclusion Criteria:
- Proven Presence of neuropsychological disorders
- Patients with deep brain stimulation
- Diagnosis of somatic pathology diagnosed
- Private Patient freedom or protected adult (under guardianship)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Parkinsonian
Patient Arm: Parkinsonian will complete several scale of evaluation.
Behavioral: Completion of scales evaluation
|
Patient complete scores to perfectionism scales (Frost Multidimensional Perfectionism Scales (FMPS), Hewitt Multidimensional Perfectionism Scale (HMPS), scores to depression scale (Beck Depression Inventory (BDI)) and anxiety scale (State Trait Anxiety Inventory (STAI))
|
|
OTHER: Dystonic
Comparator Arm: Dystonic patient will complete several scale of evaluation.
Behavioral: Completion of scales evaluation
|
Patient complete scores to perfectionism scales (Frost Multidimensional Perfectionism Scales (FMPS), Hewitt Multidimensional Perfectionism Scale (HMPS), scores to depression scale (Beck Depression Inventory (BDI)) and anxiety scale (State Trait Anxiety Inventory (STAI))
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perfectionism evaluation 1
Time Frame: Day 0
|
Scores to perfectionism scales (Frost Multidimensional Perfectionism Scales (FMPS)
|
Day 0
|
|
Perfectionism evaluation 2
Time Frame: Day 0
|
Hewitt Multidimensional Perfectionism Scale (HMPS).
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression and anxiety evaluation 1
Time Frame: Day 0
|
Scores to depression scale (Beck Depression Inventory (BDI))
|
Day 0
|
|
Depression and anxiety evaluation 2
Time Frame: Day 0
|
anxiety scale (State Trait Anxiety Inventory (STAI))
|
Day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pierre KRYSTKOWIAK, MD, PhD, CHU Amiens
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2014_843_0002
- 2013-A01302-43 (OTHER: ID-RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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