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

NCT06363331 | Completed

• 1 other identifier: 2020I054
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Social Behavior

Keywords

sustance related disorder

Outcome Measures

Primary Outcomes (1)

• Assess the presence of dysfunctions in the subdomains of social cognition

  Social cognition by MASC test

  up to 12 months

Secondary Outcomes (1)

• Accuracy and efficacy of ET® in patients with SDB

  up to 12 months

Study Arms (3)

Patients TRS without social cognition damage

NO INTERVENTION

Patients TRS without damage without intervention

Patients TRS with Social Cognition control

NO INTERVENTION

Patients TRS with social cognition damage with regular therapy in the centre

Patients TRS with social cognition with Emotional Training

EXPERIMENTAL

Patients TRS with social cognition damage with Emotional Training therapy in the centre

Behavioral: Emotional Training

Interventions

Emotional Training BEHAVIORAL

Emotional Training Therapy following the programme in the computer

Patients TRS with social cognition with Emotional Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with substance-related disorders (SUD) and other addictions according to DSM-5 diagnosed by an expert clinician.
• Have the capacity to consent (competence).
• Read the project information sheet and sign the informed consent.
• Age\>18 years-old

You may not qualify if:

• Illiterate
• Intellectual deficiency defined as IQ\<70,
• History of moderate or severe neurological pathology (TBI, stroke, etc.),
• Current acute psychiatric process
• Abstinence of less than 15 days,
• Advanced cognitive impairment that does not allow evaluation.
• Have participated in another similar study

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (2)

Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

Location

Galicia Sur Health Research Institute

Vigo, Pontevedra, 36213, Spain

Location

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: April 12, 2024
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)