Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363331
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2024-01-31
Brief Title:
Efficacy of the Social Cognition Rehabilitation Program E-motional Training in the Treatment of Patients With Substance-related Disorders
Sponsor:
Fundacin Biomedica Galicia Sur
Organization:
Fundacin Biomedica Galicia Sur
Study Overview
Official Title:
Efficacy of the Social Cognition Rehabilitation Program E-motional Training ET in the Treatment of Patients With Substance-related Disorders and Development of Biomarkers Predicting Response Through Proteomics
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drug use substance use disorders SUD and other addictive behaviors are problems of enormous socio-health impact that still require a great research effort to improve the diagnostic and therapeutic procedures used 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 evolutionary After implementing neuropsychological evaluation techniques for diagnostic improvement addresses the search for procedures that allow working on cognitive and executive deficits as a specific therapeutic target
To characterize the presence of alterations in the domains that make up social cognition SC in patients with SUD and test in our healthcare units the ET program already tested both experimentally and at beta level It is an online self-training program for CS rehabilitation that includes modules for emotion recognition RE Theory of Mind ToM and attributional style AS
To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training using advanced LC-ESI proteomics techniques MSMS in saliva since previous studies in a population with schizophrenia subjected to different neurorehabilitation therapies It is also intended to subsequently improve the instrument ET through the implementation of big data analysis and machine learning and the introduction of automated user management At this level the objective is to determine after the first games the type of game and the intensity required to improve the users performance until it reaches normality
From the perspective of the State Plan for Scientific and Technical Research and Innovation this project combines CLINICAL AND TRANSLATIONAL RESEARCH based on the evidence of scientific and technological knowledge and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services Health for people with SUD
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 evolutionary After implementing neuropsychological evaluation techniques for diagnostic improvement addresses the search for procedures that allow working on cognitive and executive deficits as a specific therapeutic target
To characterize the presence of alterations in the domains that make up social cognition SC in patients with SUD and test in our healthcare units the ET program already tested both experimentally and at beta level It is an online self-training program for CS rehabilitation that includes modules for emotion recognition RE Theory of Mind ToM and attributional style AS
To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training using advanced LC-ESI proteomics techniques MSMS in saliva since previous studies in a population with schizophrenia subjected to different neurorehabilitation therapies It is also intended to subsequently improve the instrument ET through the implementation of big data analysis and machine learning and the introduction of automated user management At this level the objective is to determine after the first games the type of game and the intensity required to improve the users performance until it reaches normality
From the perspective of the State Plan for Scientific and Technical Research and Innovation this project combines CLINICAL AND TRANSLATIONAL RESEARCH based on the evidence of scientific and technological knowledge and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services Health for people with SUD
Detailed Description:
HYPOTHESIS There is evidence on 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 CS 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
GENERAL OBJECTIVES
1 To study the presence of CS dysfunctions in a clinical sample of patients treated in drug addiction care facilities
2 To study the therapeutic efficacy of the ET program in patients with SUD who present SC dysfunctions
3 Identify new biomarkers in saliva using mass spectrometry techniques LC-ESI-MSMS that contribute to predicting patients who would benefit from receiving therapy with the ET program
4 Improve the ET instrument to serve new types of users both in the healthcare and educational environments and for future adaptation to commercial exploitation
SPECIFIC OBJECTIVES
11 Evaluate the presence of dysfunctions in the subdomains of the CS 12 Evaluate gender differences in the presence of SC dysfunctions 21 Evaluate the effectiveness of ET to improve CS in patients with SUD 22 Evaluate the effectiveness of ET on the therapeutic response adherence quality of life symptomatological perception relapses
23 Gender differences in the efficacy of ET treatment 31 Identify molecular patterns in saliva that are associated with SC dysfunctions 32 Identify biomarkers that predict therapeutic response 31 Evaluate gender differences in the study of biomarkers 41 Collect observations and suggestions from participating researchers to improve the ET 42 Collect observations and suggestions from participating patients for the improvement of the ET
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 the Valencian Community and Portugal will be recruited to carry out the phase of collecting sociodemographic variables descriptive and psychometric evaluation using the battery described below
To study the therapeutic efficacy of the ET program in patients with SUD 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 SUD 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 patients who 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 the healthcare and educational environment and for its future adaptation for commercial exploitation observations and evaluations of researchers and patients will be recorded in order to implement potential future ET improvements STUDY POPULATION Patients who begin treatment in care facilities of the drug addiction network 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 180 minutes For the proposed protocol at least 3 evaluation sessions are required
The assessment of cognitiveexecutive functioning requires a 30-minute session
The assessment of social cognition requires 2 sessions of 75 minutes
Patients will be evaluated before and after the intervention and the evaluation will be repeated after 12 months using the instruments described below
Cognitive functioning
Wechsler Scale for the Measurement of Intelligence in Adults and Adolescents WAIS III
STROOP test
D2 Attention Test Social cognition
Innuendo test
Ekman 60 Faces Test
Happés strange stories
Movie for the Assessment of Social Cognition MASC
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
GENERAL OBJECTIVES
1 To study the presence of CS dysfunctions in a clinical sample of patients treated in drug addiction care facilities
2 To study the therapeutic efficacy of the ET program in patients with SUD who present SC dysfunctions
3 Identify new biomarkers in saliva using mass spectrometry techniques LC-ESI-MSMS that contribute to predicting patients who would benefit from receiving therapy with the ET program
4 Improve the ET instrument to serve new types of users both in the healthcare and educational environments and for future adaptation to commercial exploitation
SPECIFIC OBJECTIVES
11 Evaluate the presence of dysfunctions in the subdomains of the CS 12 Evaluate gender differences in the presence of SC dysfunctions 21 Evaluate the effectiveness of ET to improve CS in patients with SUD 22 Evaluate the effectiveness of ET on the therapeutic response adherence quality of life symptomatological perception relapses
23 Gender differences in the efficacy of ET treatment 31 Identify molecular patterns in saliva that are associated with SC dysfunctions 32 Identify biomarkers that predict therapeutic response 31 Evaluate gender differences in the study of biomarkers 41 Collect observations and suggestions from participating researchers to improve the ET 42 Collect observations and suggestions from participating patients for the improvement of the ET
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 the Valencian Community and Portugal will be recruited to carry out the phase of collecting sociodemographic variables descriptive and psychometric evaluation using the battery described below
To study the therapeutic efficacy of the ET program in patients with SUD 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 SUD 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 patients who 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 the healthcare and educational environment and for its future adaptation for commercial exploitation observations and evaluations of researchers and patients will be recorded in order to implement potential future ET improvements STUDY POPULATION Patients who begin treatment in care facilities of the drug addiction network 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 180 minutes For the proposed protocol at least 3 evaluation sessions are required
The assessment of cognitiveexecutive functioning requires a 30-minute session
The assessment of social cognition requires 2 sessions of 75 minutes
Patients will be evaluated before and after the intervention and the evaluation will be repeated after 12 months using the instruments described below
Cognitive functioning
Wechsler Scale for the Measurement of Intelligence in Adults and Adolescents WAIS III
STROOP test
D2 Attention Test Social cognition
Innuendo test
Ekman 60 Faces Test
Happés strange stories
Movie for the Assessment of Social Cognition MASC
Ambiguous Intentions Hostility Questionnaire AIHQ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None