- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03371277
Attributional Style and Parkinson's Disease (ParkAIHQ)
Attributional Style Assessment in Patients With Parkinson's Disease Treated With Deep Brain Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To explore attribution bias in PD population, the Ambiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007) will be used. The participants will be asked to read 15 vignettes, to imagine the scenario happening to her or him (e.g., ''You walk past a bunch of teenagers at a mall and you hear them start to laugh''), and to write down the reason why the other person (or persons) acted that way toward you. Two independent raters will subsequently code this written response for the purpose of computing a ''hostility index'' (described below). The participant will then rate, on Likert scales, whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes''), how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry''), and how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much''). Finally, the participant will be asked to write down how she or he would respond to the situation, which will be later coded by two independent raters to compute an ''aggression index'' (described in Combs, 2007).
Socio-demographic data, subsyndromic symptoms of depression and anxiety, paranoia symptoms and cognitive functions will also be assessed to explore the confounding factors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reims, France, 51092
- CHU Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria :
- Diagnostic of Parkinson's disease by a neurologist
- Native French speaker
- Affiliated to social security
- Unmodified PD treatment for at least 2 weeks before the inclusion
- Over 18 years-old
- Accepting the study after reading the information note and signing the consentment form
Exclusion criteria :
- Diagnostic of bipolar disorder or schizophrenia
- Abuse and dependence on psychoactive substances according to the DSM V criteria
- Disabling sensory disorders
- Mental retardation or cognitive deterioration (e.g. dementia), with the incapacity to answer to the questionnaires.
- Patients under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm1
patients with Parkinson's disease treated with deep brain stimulation.
|
Ambiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007)
|
|
Experimental: Arm2
patients with Parkinson's disease treated without deep brain stimulation.
|
Ambiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attributional style
Time Frame: Day 0
|
The Ambiguous Intentions Hostility Questionnaire (Combs et al., 2006) will be used to assess attributional style
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
depression
Time Frame: Day 0
|
The Hamilton Depression Rating scale (Hamilton, 1967 )will be used to assess presence of depression
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO17112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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