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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 4
- 主要终点
- Assess the presence of dysfunctions in the subdomains of social cognition
研究概览
简要总结
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.
详细描述
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:
- To study the presence of CS dysfunctions in a clinical sample of patients treated in drug addiction care facilities.
- To study the therapeutic efficacy of the ET® program in patients with SUD who present SC dysfunctions.
- Identify new biomarkers in saliva, using mass spectrometry techniques (LC-ESI-MS/MS), that contribute to predicting patients who would benefit from receiving therapy with the ET® program.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assess the presence of dysfunctions in the subdomains of social cognition
时间窗: up to 12 months
Social cognition by MASC test
次要结局
- Accuracy and efficacy of ET® in patients with SDB(up to 12 months)