Efficacy of the E-motional Training Program for Improving Social Cognition in People With Dual Pathology in a Clinical and Prison Environment

NCT06514937 | Not Yet Recruiting

• 1 other identifier: 2023I086
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Social Behavior

Keywords

dual pathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy and efficacy of ET® in patients with dual pathology

  up to 12 months

Study Arms (3)

Patients with dual pathology without social cognition damage

NO INTERVENTION

Patients with dual pathology without damage without intervention

Patients with dual pathology with Social Cognition damage control

NO INTERVENTION

Patients with dual pathology with social cognition damage with regular therapy in the centre

Patients with dual pathology with social cognition with Emotional Training

EXPERIMENTAL

Patients with dual pathology 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 with dual pathology with social cognition with Emotional Training

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participant eligibility is based of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with dual pathology 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
• 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
• Plan Nacional sobre Drogas: collaborator

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Carlos Spuch, PhD

CONTACT

0034986217466; carlos.spuch@iisgaliciasur.es

Tania Rivera, PhD

CONTACT

0034986217466; tania.rivera@iisgaliciasu.es

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: July 17, 2024
• First Posted: July 23, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share