Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06363331 |
| Other study ID # |
2020I054 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Fundacin Biomedica Galicia Sur |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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:
1. To study the presence of CS dysfunctions in a clinical sample of patients treated in
drug addiction care facilities.
2. To study the therapeutic efficacy of the ET® program in patients with SUD who present SC
dysfunctions.
3. 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.
4. 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:
1.1 Evaluate the presence of dysfunctions in the subdomains of the CS 1.2 Evaluate gender
differences in the presence of SC dysfunctions 2.1 Evaluate the effectiveness of ET® to
improve CS in patients with SUD. 2.2 Evaluate the effectiveness of ET® on the therapeutic
response: adherence, quality of life, symptomatological perception, relapses.
2.3 Gender differences in the efficacy of ET® treatment 3.1 Identify molecular patterns in
saliva that are associated with SC dysfunctions 3.2 Identify biomarkers that predict
therapeutic response. 3.1 Evaluate gender differences in the study of biomarkers 4.1 Collect
observations and suggestions from participating researchers to improve the ET® 4.2 Collect
observations and suggestions from participating patients for the improvement of the ET®
Methodology (subjects, variables, data collection, analysis plan):
To study the presence of SC dysfunctions in a clinical sample of patients treated in drug
addiction care facilities, patients with a diagnosis of SUD who begin treatment in care
centers in Galicia, the Valencian Community and Portugal will be recruited to carry out the
phase of collecting sociodemographic variables. , descriptive and psychometric evaluation
using the battery described below.
To study the therapeutic efficacy of the ET® program in patients with SUD who present SC
dysfunctions, a multicenter, longitudinal, prospective, controlled and randomized multimodal
(proteomic, neurocognitive and clinical) study phase on the effectiveness of ET® will be
carried out. Early prediction of response in patients with SUD requiring social cognition
rehabilitation treatment. The response will be evaluated after 3 months (short term), after
12 sessions where activities on emotions and theory of mind are combined, and a follow-up
will be carried out after 12 months (long term).
To identify new biomarkers in saliva, using mass spectrometry techniques (LC-ESI-MS/MS),
which contribute to predicting patients who would benefit from receiving therapy with the ET®
program, saliva samples will be collected to carry out the proteomic study in all
participants in the ET® efficacy trial To improve the ET® instrument to serve new types of
users, both in the healthcare and educational environment, and for its future adaptation for
commercial exploitation, observations and evaluations of researchers and patients will be
recorded in order to implement potential future ET® improvements STUDY POPULATION: Patients
who begin treatment in care facilities of the drug addiction network, who meet the selection
criteria specified in the inclusion criteria section and who do not meet any of the exclusion
criteria.
NEUROPSYCHOLOGICAL ASSESSMENT (pre and post):
The neuropsychological evaluation time is estimated at 180 minutes. For the proposed
protocol, at least 3 evaluation sessions are required:
- The assessment of cognitive/executive functioning requires a 30-minute session.
- The assessment of social cognition requires 2 sessions of 75 minutes
Patients will be evaluated before and after the intervention, and the evaluation will be
repeated after 12 months, using the instruments described below:
Cognitive functioning
- Wechsler Scale for the Measurement of Intelligence in Adults and Adolescents (WAIS III)
- STROOP test
- D2 Attention Test Social cognition
- Innuendo test
- Ekman 60 Faces Test
- Happé's strange stories
- Movie for the Assessment of Social Cognition (MASC)
- Ambiguous Intentions Hostility Questionnaire (AIHQ)
