NCT06363331

Efficacy of the Social Cognition Rehabilitation Program E-motional Training in the Treatment of Patients With Substance-related Disorders

Completed NA Last updated 12 April 2024

What this trial tests

NA trial testing Emotional Training in Social Behavior in 231 participants. Completed in 30 December 2023.

Timeline

1 March 2022

Primary endpoint
1 December 2022

30 December 2023

Quick facts

Lead sponsor	Fundacin Biomedica Galicia Sur
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	231
Start date	1 March 2022
Primary completion	1 December 2022
Estimated completion	30 December 2023
Sites	2 locations across Spain

Drugs / interventions tested

• Emotional Training

Conditions studied

• Social Behavior — all drugs for Social Behavior →

Sponsor

Fundacin Biomedica Galicia Sur — full company profile →

Who can join

18 and older, any sex, with Social Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. MS/MS 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 user's 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impairment in social cognition in people with substance use disorders.
   Piñón-Blanco A, Rodrigues S, Teixeira J, Coutinho C, et al · · 2025 · PMID 40496828 · DOI 10.3389/fpsyt.2025.1574483