Counterfactual Thinking and Decision-making in Parkinson's Disease

Recruiting

• Conditions: Parkinson Disease
• Interventions: Behavioral: Counterfactual Inference Test

• Registration Number: NCT05756543
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-30
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Counterfactual Inference Test	Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth.
Cases	Counterfactual Inference Test	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.

Primary Outcome Measures

Name	Time	Method
CIT score	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).

Secondary Outcome Measures

Name	Time	Method
Decision-making index	Baseline	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).

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe; 🇮🇹 Piancavallo, VCO, Italy