Efficacy of the E-motional Training Program for Improving Social Cognition in People With Dual Pathology in a Clinical and Prison Environment
NCT Number: NCT06514937
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Behavior
Interventions: BEHAVIORAL: Emotional Training
Sponsor: Fundacin Biomedica Galicia Sur
Collaborators: Plan Nacional sobre Drogas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-06

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.

Primary Outcome Measures: Assess the presence of dysfunctions in the subdomains of social cognition, Social cognition by Ekman 60 Faces Test minimum and maximum values: 0 - 60 higher scores mean a better outcome., up to 12 months
Secondary Outcome Measures: Accuracy and efficacy of ET® in patients with dual pathology, Social cognition by Movie for Assessment Social Cognition (MASC) minimum and maximum values: 0 - 51 higher scores mean a better outcome., up to 12 months