Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514937
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Efficacy of the E-motional Training Program for Improving Social Cognition in People With Dual Pathology in a Clinical and Prison Environment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of the E-motional Training Program for Improving Social Cognition in People With Dual Pathology in a Clinical and Prison Environment Neuropsychological and Proteomic Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drug use substance-related disorders SUD other addictive behaviors or from a broader perspective dual pathology are problems of enormous socio-health impact that still require a great research effort to improve diagnostic and therapeutic procedures employed in healthcare practice
Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions it is necessary to be able to detect evaluate and have specific therapies for these dysfunctions and investigate among other issues the role they play in the onset and course of evolution After implementing neuropsychological evaluation techniques for diagnostic improvement the search addresses procedures that allow working on cognitive and executive deficits as a specific therapeutic target
In a previous project the investigators studied the presence of social cognition SC dysfunctions in a clinical sample of patients treated in drug addiction care facilities The investigators evaluated the therapeutic efficacy of the ET program in those who presented difficulties in SC and analyzed molecular patterns in saliva that could be associated with SC dysfunctions and predict therapeutic response The ET program is an online self-training program for SC rehabilitation that includes modules for emotion recognition ER Theory of Mind ToM and attributional style AS
To replicate the RCT carried out in patients with SUD in patients with dual pathology with difficulties in ER or ToM in addition to including a gender perspective tele-neuropsychology and searching for a biomarker or a pattern of them that predicts the patient profile that will benefit from the training using advanced LC-ESI proteomics techniques It is also intended to subsequently improve the instrument ET through the implementation of a gender perspective and big data analysis and machine learning and the introduction of automated user management
From the perspective of the STATE PLAN FOR SCIENTIFIC AND TECHNICAL RESEARCH AND INNOVATION the project combines clinical and translational research based on evidence of scientific and technological knowledge and the use of e-health enabling technologies in the area of Health Services Health for people with dual pathology with special attention to the gender perspective
Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions it is necessary to be able to detect evaluate and have specific therapies for these dysfunctions and investigate among other issues the role they play in the onset and course of evolution After implementing neuropsychological evaluation techniques for diagnostic improvement the search addresses procedures that allow working on cognitive and executive deficits as a specific therapeutic target
In a previous project the investigators studied the presence of social cognition SC dysfunctions in a clinical sample of patients treated in drug addiction care facilities The investigators evaluated the therapeutic efficacy of the ET program in those who presented difficulties in SC and analyzed molecular patterns in saliva that could be associated with SC dysfunctions and predict therapeutic response The ET program is an online self-training program for SC rehabilitation that includes modules for emotion recognition ER Theory of Mind ToM and attributional style AS
To replicate the RCT carried out in patients with SUD in patients with dual pathology with difficulties in ER or ToM in addition to including a gender perspective tele-neuropsychology and searching for a biomarker or a pattern of them that predicts the patient profile that will benefit from the training using advanced LC-ESI proteomics techniques It is also intended to subsequently improve the instrument ET through the implementation of a gender perspective and big data analysis and machine learning and the introduction of automated user management
From the perspective of the STATE PLAN FOR SCIENTIFIC AND TECHNICAL RESEARCH AND INNOVATION the project combines clinical and translational research based on evidence of scientific and technological knowledge and the use of e-health enabling technologies in the area of Health Services Health for people with dual pathology with special attention to the gender perspective
Detailed Description:
HYPOTHESIS There is evidence of the existence of social cognition SC dysfunctions in patients with SUD and its potential implications in the etiopathogenesis clinical course and response to treatment have been postulated At the healthcare level SC should be taken into account in diagnostic and therapeutic procedures
The detection of SC dysfunctions and the implementation of specific treatment for them will contribute to improving the therapeutic response of patients with SUD
The general hypotheses of the study will be
1 A high percentage of people with dual pathology and impairment of social cognition will be detected
2 People with dual pathology and impairment of social cognition will improve after the intervention with the updated version of ET
3 A panel of potential biomarkers that predict therapeutic response can be identified
GENERAL OBJECTIVES
1 Determine the prevalence of dual pathology in clinical and prison samples of people with SUD
2 Evaluate the presence of alterations in the domains that make up social cognition SC in people with dual pathology in clinical and prison samples
3 Check the effectiveness of a computerized rehabilitation program for SC the ET program in people with dual pathology who present SC dysfunctions
4 Develop a panel of biomarkers in saliva that predicts which people with dual pathology will benefit from training using shotgun mass spectrometry techniques LC-ESI-MSMS
5 Conduct the study taking into account the gender perspective
SPECIFIC OBJECTIVES
11 Assess the prevalence of mental disorders in people with an addictive disorder
12 Evaluate the differences in clinical and penitentiary environments of mental disorders in people with an addictive disorder
13 Assess sex differences in the prevalence of mental disorders in people with an addictive disorder
21 Evaluate the presence of dysfunctions in the SC of people with dual pathology
22 Evaluate the dysfunctions in the subdomains of SC of people with dual pathology
23 Evaluate the differences in clinical and penitentiary environments in SC dysfunctions in dual pathology
24 Evaluate sex differences in SC dysfunctions in dual pathology
31 Evaluate the effectiveness of the new version of the ET program in people with dual pathology
32 Evaluate the effectiveness of the new version of the ET program on therapeutic response adherence quality of life symptom perception and relapses
33 Evaluate the differences in clinical and prison settings in the effectiveness of treatment with ET
34 Assess gender differences in the efficacy of ET treatment
41 Increase the bank of saliva samples for proteomic studies 42 Identify molecular patterns in saliva that are associated with SC dysfunctions
43 Identify biomarkers that predict therapeutic response 44 Evaluate gender differences in the study of biomarkers
Methodology subjects variables data collection analysis plan
To study the presence of SC dysfunctions in a clinical sample of patients treated in drug addiction care facilities patients with a diagnosis of SUD who begin treatment in care centers in Galicia Madrid and Portugal and in the prison in Cuenca will be recruited to carry out the phase of collecting sociodemographic variables descriptive data and psychometric evaluation using the battery described below
To study the therapeutic efficacy of the ET program in patients with dual pathology who present SC dysfunctions a multicenter longitudinal prospective controlled and randomized multimodal proteomic neurocognitive and clinical study phase on the effectiveness of ET will be carried out Early prediction of response in patients with dual pathology requiring social cognition rehabilitation treatment The response will be evaluated after 3 months short term after 12 sessions where activities on emotions and theory of mind are combined and a follow-up will be carried out after 12 months long term
To identify new biomarkers in saliva using mass spectrometry techniques LC-ESI-MSMS which contribute to predicting which patients would benefit from receiving therapy with the ET program saliva samples will be collected to carry out the proteomic study in all participants in the ET efficacy trial To improve the ET instrument to serve new types of users both in healthcare and educational environments and for its future adaptation for commercial exploitation observations and evaluations of researchers and patients will be recorded to implement potential future ET improvements
STUDY POPULATION
Patients who begin treatment in care facilities of the drug addiction network and prison who meet the selection criteria specified in the inclusion criteria section and who do not meet any of the exclusion criteria
NEUROPSYCHOLOGICAL ASSESSMENT pre and post
The neuropsychological evaluation time is estimated at 120 minutes For the proposed protocol at least 2 evaluation sessions are required
The assessment of dual pathology requires a 30-minute session
The assessment of social cognition requires 1 session of 30 minutes and 1 session of 60 minutes
Patients will be evaluated before and after the intervention and the evaluation will be repeated after 12 months using the instruments described below
Clinical evaluation
Dual Pathology Screening Interview ECDD
Symptom Checklist-90-R SCL-90-R
Assessment of Social Cognition
The Interpersonal Reactivity Index IRI
Ekman 60 Faces Test
Movie for the Assessment of Social Cognition MASC
Marlowe-Crowne Social Desirability Scale MCSDS
Ambiguous Intentions Hostility Questionnaire AIHQ
The detection of SC dysfunctions and the implementation of specific treatment for them will contribute to improving the therapeutic response of patients with SUD
The general hypotheses of the study will be
1 A high percentage of people with dual pathology and impairment of social cognition will be detected
2 People with dual pathology and impairment of social cognition will improve after the intervention with the updated version of ET
3 A panel of potential biomarkers that predict therapeutic response can be identified
GENERAL OBJECTIVES
1 Determine the prevalence of dual pathology in clinical and prison samples of people with SUD
2 Evaluate the presence of alterations in the domains that make up social cognition SC in people with dual pathology in clinical and prison samples
3 Check the effectiveness of a computerized rehabilitation program for SC the ET program in people with dual pathology who present SC dysfunctions
4 Develop a panel of biomarkers in saliva that predicts which people with dual pathology will benefit from training using shotgun mass spectrometry techniques LC-ESI-MSMS
5 Conduct the study taking into account the gender perspective
SPECIFIC OBJECTIVES
11 Assess the prevalence of mental disorders in people with an addictive disorder
12 Evaluate the differences in clinical and penitentiary environments of mental disorders in people with an addictive disorder
13 Assess sex differences in the prevalence of mental disorders in people with an addictive disorder
21 Evaluate the presence of dysfunctions in the SC of people with dual pathology
22 Evaluate the dysfunctions in the subdomains of SC of people with dual pathology
23 Evaluate the differences in clinical and penitentiary environments in SC dysfunctions in dual pathology
24 Evaluate sex differences in SC dysfunctions in dual pathology
31 Evaluate the effectiveness of the new version of the ET program in people with dual pathology
32 Evaluate the effectiveness of the new version of the ET program on therapeutic response adherence quality of life symptom perception and relapses
33 Evaluate the differences in clinical and prison settings in the effectiveness of treatment with ET
34 Assess gender differences in the efficacy of ET treatment
41 Increase the bank of saliva samples for proteomic studies 42 Identify molecular patterns in saliva that are associated with SC dysfunctions
43 Identify biomarkers that predict therapeutic response 44 Evaluate gender differences in the study of biomarkers
Methodology subjects variables data collection analysis plan
To study the presence of SC dysfunctions in a clinical sample of patients treated in drug addiction care facilities patients with a diagnosis of SUD who begin treatment in care centers in Galicia Madrid and Portugal and in the prison in Cuenca will be recruited to carry out the phase of collecting sociodemographic variables descriptive data and psychometric evaluation using the battery described below
To study the therapeutic efficacy of the ET program in patients with dual pathology who present SC dysfunctions a multicenter longitudinal prospective controlled and randomized multimodal proteomic neurocognitive and clinical study phase on the effectiveness of ET will be carried out Early prediction of response in patients with dual pathology requiring social cognition rehabilitation treatment The response will be evaluated after 3 months short term after 12 sessions where activities on emotions and theory of mind are combined and a follow-up will be carried out after 12 months long term
To identify new biomarkers in saliva using mass spectrometry techniques LC-ESI-MSMS which contribute to predicting which patients would benefit from receiving therapy with the ET program saliva samples will be collected to carry out the proteomic study in all participants in the ET efficacy trial To improve the ET instrument to serve new types of users both in healthcare and educational environments and for its future adaptation for commercial exploitation observations and evaluations of researchers and patients will be recorded to implement potential future ET improvements
STUDY POPULATION
Patients who begin treatment in care facilities of the drug addiction network and prison who meet the selection criteria specified in the inclusion criteria section and who do not meet any of the exclusion criteria
NEUROPSYCHOLOGICAL ASSESSMENT pre and post
The neuropsychological evaluation time is estimated at 120 minutes For the proposed protocol at least 2 evaluation sessions are required
The assessment of dual pathology requires a 30-minute session
The assessment of social cognition requires 1 session of 30 minutes and 1 session of 60 minutes
Patients will be evaluated before and after the intervention and the evaluation will be repeated after 12 months using the instruments described below
Clinical evaluation
Dual Pathology Screening Interview ECDD
Symptom Checklist-90-R SCL-90-R
Assessment of Social Cognition
The Interpersonal Reactivity Index IRI
Ekman 60 Faces Test
Movie for the Assessment of Social Cognition MASC
Marlowe-Crowne Social Desirability Scale MCSDS
Ambiguous Intentions Hostility Questionnaire AIHQ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None