Parkinson's DiseaseParkAIHQNCT03371277
Attributional Style and Parkinson's Disease
A study testing Medical visit for specific questionnaires in people with Parkinson's Disease, run by CHU de Reims at 1 site in France.
Trial summary
Parkinson's disease (PD) is a common neurodegenerative disorder affecting 1-2% of the population over 65 years-old. In addition to the motor impairment characterized by resting tremor, bradykinesia, rigidity and postural instability, patients suffer with non-motor symptoms such as dysautonomia syndrome, sleep… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Medical visit for specific questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2018to 7 Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attributional Style Assessment in Patients With Parkinson's Disease Treated With Deep Brain Stimulation
Parkinson's disease (PD) is a common neurodegenerative disorder affecting 1-2% of the population over 65 years-old. In addition to the motor impairment characterized by resting tremor, bradykinesia, rigidity and postural instability, patients suffer with non-motor symptoms such as dysautonomia syndrome, sleep disturbances, depressive disorders, delusional disorders and cognitive disorders. Research and management of these non-motor symptoms is essential because these can be disabling and have a negative impact on the quality of life of patients. Among cognitive functions, social cognition is defined as the aspect that is dedicated to process social information for adaptive functioning. More specifically, it refers to an intricate set of higher-order neuropsychological domains that allow for adaptive behaviors in response to others. Four dimensions are usually included in this construct: theory of mind (ToM), emotion processing, social perception and social knowledge, and attributional style. Recently, different categories of social cognition have been studied in patients suffering from PD, such as the ToM or the recognition of facial emotions. Other aspects of social cognition that seem relevant in this population are still poorly studied; the attributional style is a cognitive bias defined as "the way we explain the causes of the positive or negative events that occur". Indeed, different causes can be attributed to an event, and this attribution is shared between oneself, others and other factors related to the situation. People with attribution bias may mistakenly attribute to one cause all the situations. For example, when an individual blame the others for an event, he may develop a feeling of hostility that may lead to maladaptive behavior such as aggression and thus affect his social functioning. The impact of PD treatments, particularly deep brain stimulation (DBS), on the ToM has been studied, showing a deficit after stimulation. No study has assessed the impact of therapeutics on the attributional style of PD patients. In this context, it seems relevant to evaluate the effect of deep brain stimulation on the attributional style in this population.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Medical visit for specific questionnaires
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical visit for specific questionnairesOther
Ambiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007)
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | patients with Parkinson's disease treated with deep brain stimulation. Receives: Other: Medical visit for specific questionnaires |
| Arm2 | Experimental | patients with Parkinson's disease treated without deep brain stimulation. Receives: Other: Medical visit for specific questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attributional style
The Ambiguous Intentions Hostility Questionnaire (Combs et al., 2006) will be used to assess attributional style
Measured: Day 0
Secondary outcomes (1)
depression
The Hamilton Depression Rating scale (Hamilton, 1967 )will be used to assess presence of depression
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start22 Jan 2018
- Primary completion7 Jul 2018
- Study completion7 Jul 2018
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 CHU de ReimsThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371277
- Sponsor's protocol ID
- PO17112
- Acronym
- ParkAIHQ
- Status last verified
- Oct 2018
- First submitted
- 7 Dec 2017
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Decombe L, Henry A, Decombe R, Tir M, Doe de Maindreville A, Galland Hairabedian L, Kaladjian A, Raucher-Chene D. "Accidental, really?" Attributional bias in patients with Parkinson's disease. Parkinsonism Relat Disord. 2022 Feb;95:18-22. doi: 10.1016/j.parkreldis.2021.12.013. Epub 2021 Dec 23.
PubMed 34959046
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attributional Style Assessment in Patients With Parkinson's Disease Treated With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT03371277
- Acronym / sponsor ID
- ParkAIHQ / PO17112
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 13 Dec 2017 (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.
Parkinson's disease (PD) is a common neurodegenerative disorder affecting 1-2% of the population over 65 years-old. In addition to the motor impairment characterized by resting tremor, bradykinesia, rigidity and postural instability, patients suffer with non-motor symptoms such as dysautonomia syndrome, sleep disturbances, depressive disorders, delusional disorders and cognitive disorders. Research and management of these non-motor symptoms is essential because these can be disabling and have a negative impact on the quality of life of patients. Among cognitive functions, social cognition is defined as the aspect that is dedicated to process social information for adaptive functioning. More specifically, it refers to an intricate set of higher-order neuropsychological domains that allow for adaptive behaviors in response to others. Four dimensions are usually included in this construct: theory of mind (ToM), emotion processing, social perception and social knowledge, and attributional style. Recently, different categories of social cognition have been studied in patients suffering from PD, such as the ToM or the recognition of facial emotions. Other aspects of social cognition that seem relevant in this population are still poorly studied; the attributional style is a cognitive bias defined as "the way we explain the causes of the positive or negative events that occur". Indeed, different causes can be attributed to an event, and this attribution is shared between oneself, others and other factors related to the situation. People with attribution bias may mistakenly attribute to one cause all the situations. For example, when an individual blame the others for an event, he may develop a feeling of hostility that may lead to maladaptive behavior such as aggression and thus affect his social functioning. The impact of PD treatments, particularly deep brain stimulation (DBS), on the ToM has been studied, showing a deficit after stimulation. No study has assessed the impact of therapeutics on the attributional style of PD patients. In this context, it seems relevant to evaluate the effect of deep brain stimulation on the attributional style in this population.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Other: Medical visit for specific questionnairespatients with Parkinson's disease treated with deep brain stimulation. |
| Arm2 | Experimental | Other: Medical visit for specific questionnairespatients with Parkinson's disease treated without deep brain stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Medical visit for specific questionnairesAmbiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007) | Other | Arm1, Arm2 |
Primary outcome
Attributional style
Time frame: Day 0
The Ambiguous Intentions Hostility Questionnaire (Combs et al., 2006) will be used to assess attributional style
1 secondary outcome
depression
Time frame: Day 0
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 21 Jan 2026.
- Background: PubMed 34959046Decombe L, Henry A, Decombe R, Tir M, Doe de Maindreville A, Galland Hairabedian L, Kaladjian A, Raucher-Chene D. "Accidental, really?" Attributional bias in patients with Parkinson's disease. Parkinsonism Relat Disord. 2022 Feb;95:18-22. doi: 10.1016/j.parkreldis.2021.12.013. Epub 2021 Dec 23.
- 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?
A study testing Medical visit for specific questionnaires in people with Parkinson's Disease, run by CHU de Reims 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 6 inclusion and 5 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 21 Jan 2026. 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?
Attributional style (time frame: Day 0). 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 NCT03371277, 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 21 Jan 2026.