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

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05756543
Collaborator
Istituti Clinici Scientifici Maugeri SpA (Other)
102
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Counterfactual Inference Test

Study Design

Study Type:
Observational
Anticipated Enrollment :
102 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Counterfactual Thinking About Clinical Decision and Decision-making in the Context of the Parkinson's Disease.
Actual Study Start Date :
Mar 30, 2022
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe Piancavallo VCO Italy 28824

Sponsors and Collaborators

  • Istituto Auxologico Italiano
  • Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Principal Investigator: Sofia Tagini, PhD, IRCCS Istituto Auxologico Italiano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05756543
Other Study ID Numbers:
  • 21C129
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2023