Parkinson DiseaseCT_PDNCT05756543
Counterfactual Thinking and Decision-making in Parkinson's Disease
An observational study of Parkinson Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by Parkinson's Disease when compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Counterfactual Inference Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2022to 30 Mar 2024
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with Parkinson's Disease will be consecutively recruited at the beginning of a diagnostic recovery or rehabilitation treatment in the involved institutions.
Who may be able to join
- Diagnosis of Parkinson's disease, according to the medical assessment performed by trained neurologists.
Who cannot join
- Diagnosis of Obstructive Sleep Apnea Syndrome, according to the clinical assessment;
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders;
- Dementia, according to the clinical/neuropsychological assessment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824
About this study
Official title: Counterfactual Thinking About Clinical Decision and Decision-making in the Context of the Parkinson's Disease.
The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by Parkinson's Disease when compared to healthy individuals.
- Conditions
- Parkinson Disease
- Being tested
- Counterfactual Inference Test
- Keywords
- counterfactual thinking, decision-making, neuropsychological assessment, clinical setting
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterfactual Inference TestBehavioural
All participants were asked to complete the Counterfactual Inference Test - CIT (McNamara et al., 2003), a neuropsychological test that measures the ability to produce counterfactual-derived inferences. Moreover, the decision-making ability will be specifically tested through ad-hoc questionnaire (i.e., the Decision-Making Questionnaire). Finally, all participants will be screened with an extensive neuropsychological assessment, particularly on executive functioning.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Individuals diagnosed with Parkinson's Disease consecutively recruited at the beginning of rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Concurrent neurological, neurodevelopmental (e.g., autism), motor or psychiatric disorders were exclusion criteria. Receives: Behavioral: Counterfactual Inference Test | |
| Controls | Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth. Receives: Behavioral: Counterfactual Inference Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIT score
Score at the Counterfactual inference test (CIT). The questionnaire is a four question forced choice test based on past research regarding factors that enhance counterfactual thinking. For each of the four questions, events experienced by two individuals are presented, and three response options are given. Only one option is the valid: the score is 1. For the not valid options, the score will be 0. Overall, the score range for the questionnaire is from 0 (worse performance) to 4 (best performance).
Measured: Baseline
Secondary outcomes (1)
Decision-making index
Score at the Decision-Making Questionnaire. The self-report questionnaire assesses the decision making ability according to 7 questions, with a 5-item Likert's scale. The overall score (i.e., the sum of the scores at all questions) can range from 7 (worse decision making strategy) to 35 (best decision making strategy).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start30 Mar 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Sponsor
- Investigators
- Sofia Tagini, PhD, Principal investigator, IRCCS Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756543
- Sponsor's protocol ID
- 21C129
- Acronym
- CT_PD
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counterfactual Thinking About Clinical Decision and Decision-making in the Context of the Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05756543
- Acronym / sponsor ID
- CT_PD / 21C129
- Conditions
- Parkinson Disease
- Keywords
- counterfactual thinking, decision-making, neuropsychological assessment, clinical setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 Mar 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.
The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by Parkinson's Disease when compared to healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: Counterfactual Inference TestIndividuals diagnosed with Parkinson's Disease consecutively recruited at the beginning of rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Concurrent neurological, neurodevelopmental (e.g., autism), motor or psychiatric disorders were exclusion criteria. |
| Controls | – | Behavioral: Counterfactual Inference TestAge-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Parkinson's Disease will be consecutively recruited at the beginning of a diagnostic recovery or rehabilitation treatment in the involved institutions.
Key inclusion criteria (1 listed)
- Diagnosis of Parkinson's disease, according to the medical assessment performed by trained neurologists.
Key exclusion criteria (3 listed)
- Diagnosis of Obstructive Sleep Apnea Syndrome, according to the clinical assessment;
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders;
- Dementia, according to the clinical/neuropsychological assessment.
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 |
|---|---|---|
| Counterfactual Inference TestAll participants were asked to complete the Counterfactual Inference Test - CIT (McNamara et al., 2003), a neuropsychological test that measures the ability to produce counterfactual-derived inferences. Moreover, the decision-making ability will be specifically tested through ad-hoc questionnaire (i.e., the Decision-Making Questionnaire). Finally, all participants will be screened with an extensive neuropsychological assessment, particularly on executive functioning. | Behavioural | Cases, Controls |
Primary outcome
CIT score
Time frame: Baseline
Score at the Counterfactual inference test (CIT). The questionnaire is a four question forced choice test based on past research regarding factors that enhance counterfactual thinking. For each of the four questions, events experienced by two individuals are presented, and three response options are given. Only one option is the valid: the score is 1. For the not valid options, the score will be 0. Overall, the score range for the questionnaire is from 0 (worse performance) to 4 (best performance).
1 secondary outcome
Decision-making index
Time frame: 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 26 Aug 2025.
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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.
Sofia Tagini, PhD principal investigator
IRCCS Istituto Auxologico Italiano
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 Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
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 3 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 26 Aug 2025. 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 Italy. 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?
CIT score (time frame: 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 26 Aug 2025.