Counterfactual Thinking and Decision-making in Parkinson's Disease (CT_PD)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Counterfactual Inference Test

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • VCO
    • Piancavallo, VCO, Italy, 28824
      • IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
Controls; Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth.	Behavioral: Counterfactual Inference Test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: Istituti Clinici Scientifici Maugeri SpA
• Investigators: Principal Investigator: Sofia Tagini, PhD, IRCCS Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: decision-making; neuropsychological assessment; clinical setting; counterfactual thinking
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 21C129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No