Counterfactual Thinking and Decision-making in Parkinson's Disease

NCT05756543 | Completed

• 1 other identifier: 21C129
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

counterfactual thinking; decision-making; neuropsychological assessment; clinical setting

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline

Secondary Outcomes (1)

• Decision-making index

  Baseline

Study Arms (2)

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.

Behavioral: Counterfactual Inference Test

Controls

Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth.

Behavioral: Counterfactual Inference Test

Interventions

Counterfactual Inference Test BEHAVIORAL

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.

Cases; Controls

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosis of Parkinson's disease, according to the medical assessment performed by trained neurologists.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sofia Tagini, PhD

  IRCCS Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: March 30, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

IT (1)