Counterfactual Thinking and Decision-making in Parkinson's Disease

Parkinson Disease Clinical Trial

— CT_PD  

Official title:

Counterfactual Thinking About Clinical Decision and Decision-making in the Context of the Parkinson's Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756543
• Other study ID #: 21C129
• Status: Recruiting
• Start date: March 30, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Federica Scarpina, PhD
• Phone: +39032351
• Email: f.scarpina[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe	Piancavallo	VCO

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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