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Therapy of Pragmatic Disorders in Brain-damaged Individuals

Primary Purpose

Brain Injuries, Traumatic, Right Hemispheric Stroke

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Speech and language therapy
Sponsored by
University of Neuchatel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have been the victim, in adulthood, of a moderate to severe traumatic brain injury (TBI) or a stroke, with at least right frontal lesions (objectified by imaging). The time between the TBI or stroke and participation in this study should be greater than six months.
  • Be of French mother tongue or have an excellent mastery of French.
  • Be between 20 and 65 years old.
  • Be right-handed
  • Present problems in the understanding of non-literal language (irony, indirect requests), objectified by a neuropsychological examination.

Exclusion Criteria:

  • Have a history of psychiatric disorder affecting social cognition (according to DSM-V criteria), and more specifically: autism, schizophrenia, bipolar disorders, major depressive disorders, borderline personality disorders, generalized anxiety disorders, obsessive-compulsive disorders, phobia social and eating disorders (anorexia, bulimia).
  • Have chronic symptoms of an alcohol or drug dependence disorder (according to DSM-V criteria).
  • Have significant uncorrected vision and/or hearing problems.
  • Have aphasia and/or significant reading and comprehension problems.
  • Present significant spatial neglect.
  • Present an impaired capacity for judgment and discernment, objectified by a neuropsychological evaluation.
  • Have been the victim of several TBI or stroke

Sites / Locations

  • Université de Neuchâtel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain-injured participants

Arm Description

Outcomes

Primary Outcome Measures

Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered twice before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered twice before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.

Secondary Outcome Measures

Change from a nonverbal test of theory of mind 48 hours after the end of the therapy
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a nonverbal test of theory of mind 1 month after the end of the therapy
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a nonverbal test of theory of mind 1 month after the end of the therapy
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a verbal test of theory of mind 48 hours after the end of the therapy
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a verbal test of theory of mind 1 month after the end of the therapy
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a verbal test of theory of mind 1 month after the end of the therapy
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a test of inhibitory control 48 hours after the end of the therapy
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a test of inhibitory control 1 month after the end of the therapy
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a test of inhibitory control 1 month after the end of the therapy
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a test of cognitive flexibility 48 hours after the end of the therapy
The test of inhibitory control (TrailMaking Test, Reitan & Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a test of cognitive flexibility 1 month after the end of the therapy
The test of inhibitory control (TrailMaking Test, Reitan & Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a test of cognitive flexibility 1 month after the end of the therapy
The test of inhibitory control (TrailMaking Test, Reitan & Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a test of working memory 48 hours after the end of the therapy
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a test of working memory 1 month after the end of the therapy
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a test of working memory 1 month after the end of the therapy
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a video task of non-literal language comprehension 48 hours after the end of the therapy
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement. The task will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a video task of non-literal language comprehension 1 month after the end of the therapy
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement. The task will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a video task of non-literal language comprehension 1 month after the end of the therapy
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement. The test task will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a daily life impact self-questionnaire 48 hours after the end of the therapy
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux & Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points. The higher the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a daily life impact self-questionnaire 1 month after the end of the therapy
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux & Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points. The higher the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a daily life impact self-questionnaire 1 month after the end of the therapy
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux & Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points.. The higher the score, the greater the impact of the disorders is considered. The questionnaire will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Change from a daily life impact hetero-questionnaire 48 hours after the end of the therapy
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from a daily life impact hetero-questionnaire 1 month after the end of the therapy
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered. The questionnaire will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.

Full Information

First Posted
January 7, 2021
Last Updated
May 17, 2022
Sponsor
University of Neuchatel
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1. Study Identification

Unique Protocol Identification Number
NCT04708561
Brief Title
Therapy of Pragmatic Disorders in Brain-damaged Individuals
Official Title
Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Neuchatel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. We also explore whether the observed progress is maintained one month after the end of treatment and whether it is generalized to neuropsychological tests, video material, and the participants' daily lives. This therapy will be administered to four individuals with brain lesions, for six weeks, at the rate of two weekly sessions of one hour.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Right Hemispheric Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain-injured participants
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Speech and language therapy
Intervention Description
The intervention focuses on understanding the thoughts of the characters. Twenty written stories will be used, which end with statements that can be interpreted literally, ironically, as a lie, a request or a faux-pas (maladroitness). At the end of each story, the participant should explain what the characters want to mean by their statement. To help the participant in his understanding of the character's intention, he will be asked: 1) To mention as many intentions as possible that can be associated with the target statement presented out of context (eg: "it's hot here" that can be interpreted literally, ironically, as a lie or a request) and to imagine contexts in connection with interpretation; 2. Analyze the relevant elements of the context (environment, the relationship between the characters, knowledge of the characters); 3. To judge the probability of the possible interpretations (pt 1) by justifying using the elements of the context analyzed previously (pt 2).
Primary Outcome Measure Information:
Title
Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy
Description
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered twice before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
Description
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered twice before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
Description
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary Outcome Measure Information:
Title
Change from a nonverbal test of theory of mind 48 hours after the end of the therapy
Description
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a nonverbal test of theory of mind 1 month after the end of the therapy
Description
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a nonverbal test of theory of mind 1 month after the end of the therapy
Description
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a verbal test of theory of mind 48 hours after the end of the therapy
Description
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a verbal test of theory of mind 1 month after the end of the therapy
Description
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a verbal test of theory of mind 1 month after the end of the therapy
Description
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a test of inhibitory control 48 hours after the end of the therapy
Description
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a test of inhibitory control 1 month after the end of the therapy
Description
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a test of inhibitory control 1 month after the end of the therapy
Description
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a test of cognitive flexibility 48 hours after the end of the therapy
Description
The test of inhibitory control (TrailMaking Test, Reitan & Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a test of cognitive flexibility 1 month after the end of the therapy
Description
The test of inhibitory control (TrailMaking Test, Reitan & Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a test of cognitive flexibility 1 month after the end of the therapy
Description
The test of inhibitory control (TrailMaking Test, Reitan & Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a test of working memory 48 hours after the end of the therapy
Description
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one. The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a test of working memory 1 month after the end of the therapy
Description
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one. The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a test of working memory 1 month after the end of the therapy
Description
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one. The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a video task of non-literal language comprehension 48 hours after the end of the therapy
Description
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement. The task will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a video task of non-literal language comprehension 1 month after the end of the therapy
Description
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement. The task will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a video task of non-literal language comprehension 1 month after the end of the therapy
Description
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement. The test task will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a daily life impact self-questionnaire 48 hours after the end of the therapy
Description
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux & Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points. The higher the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a daily life impact self-questionnaire 1 month after the end of the therapy
Description
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux & Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points. The higher the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a daily life impact self-questionnaire 1 month after the end of the therapy
Description
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux & Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points.. The higher the score, the greater the impact of the disorders is considered. The questionnaire will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up
Title
Change from a daily life impact hetero-questionnaire 48 hours after the end of the therapy
Description
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Time Frame
Baselines, 24-48 hours after the last session of the therapy
Title
Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy
Description
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered. The questionnaire will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Time Frame
Baselines, 1 month-follow-up
Title
Maintenance from a daily life impact hetero-questionnaire 1 month after the end of the therapy
Description
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered. The questionnaire will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Time Frame
24-48 hours after the last session of the therapy, 1 month-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been the victim, in adulthood, of a moderate to severe traumatic brain injury (TBI) or a stroke, with at least right frontal lesions (objectified by imaging). The time between the TBI or stroke and participation in this study should be greater than six months. Be of French mother tongue or have an excellent mastery of French. Be between 20 and 65 years old. Be right-handed Present problems in the understanding of non-literal language (irony, indirect requests), objectified by a neuropsychological examination. Exclusion Criteria: Have a history of psychiatric disorder affecting social cognition (according to DSM-V criteria), and more specifically: autism, schizophrenia, bipolar disorders, major depressive disorders, borderline personality disorders, generalized anxiety disorders, obsessive-compulsive disorders, phobia social and eating disorders (anorexia, bulimia). Have chronic symptoms of an alcohol or drug dependence disorder (according to DSM-V criteria). Have significant uncorrected vision and/or hearing problems. Have aphasia and/or significant reading and comprehension problems. Present significant spatial neglect. Present an impaired capacity for judgment and discernment, objectified by a neuropsychological evaluation. Have been the victim of several TBI or stroke
Facility Information:
Facility Name
Université de Neuchâtel
City
Neuchâtel
Country
Switzerland

12. IPD Sharing Statement

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Therapy of Pragmatic Disorders in Brain-damaged Individuals

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