NEUROPSYCHOLOGICAL REHABILITATION FOR ALCOHOL USE DISORDERS

The aim is to carry out a pilot randomized clinical trial, blinded to the researchrs (from September 2024 to June 2025), with two arms: an experimental group and a control group. The experimental group will have access to the Neuropsychological Rehabilitation program and weekly therapeutic groups. The Neuropsychological Rehabilitation program will last three months and includes three components: psychoeducation, cognitive training and social skills/emotional management training. Cognitive training will use different strategies such as: pencil and paper exercises and an online cognitive training platform - Cogweb (Neuroinova, 2007). The control group will only participate in weekly therapy groups, which consist of open groups that aim to help people manage everyday difficulties related to alcohol consumption, providing psychoeducation on coping strategies to deal with cravings.Participants will be recruited from the Alcohol and New Addictions Service (inpatient) and the Alcohol Treatment and Rehabilitation Unit (outpatient), at Hospital Júlio de Matos, ULSSJOSÉ.

In the first phase, participants will be recruited in this Service, carrying out a prior analysis, taking into account the inclusion/exclusion criteria, carried out by the treatment team,and the Montreal Cognitive Assessment - MoCA (Simões, Freitas, Santana, Firmino, Martins, Nasreddine, Vilar, 2008) also being applied, to assess whether they do not present cognitive impairment. . After this recruitment, information about the study will be provided and all doubts will be clarified, to complete the informed consent. The first assessment will take place from the 10th day of abstinence. This will involve the application of a battery of tests that includes a semi-structured interview (evaluating sociodemographic information and characterization of consumption), clinical tests (evaluating degree of dependence; anxiety and depression; quality of life) and neuropsychological tests to evaluate executive functions. One month later, an assessment will be carried out, including only the Frontal Assessment Battery - FAB and a description of consumption, as a way of monitoring progress in these components. Subsequently, two evaluations will be carried out with the complete battery, described in the outcome measures, one at three months and the other at six months. Throughout the assessment sessions or intervention sessions, users will have their consumption monitored with the alcohol test.

The primary outcome was defined as performance regarding general executive functioning, assessed with the total FAB score, comparing the baseline with the result at one, three and six months, in both groups.

As secondary outcomes the investigators intend to analyze:

• Performance in working memory, cognitive flexibility, inhibition and planning, measured by scoring the letters and numbers test of the Wechsler Intelligence Scale for adults - WAIS-III, Wisconsin Card Test ,Trail Making Test- TMT, Stroop Color and Word Test, Zoo Map and Search for Keys from the Behavioral Assessment of the Dysexecutive Syndrome (BADS) , respectively, comparing the baseline with the results at three and six months, in both groups performance in other cognitive domains such as verbal fluency (verbal fluency test score) and information processing speed (code test score), measured between the two groups, after three and six months, comparing with baseline data, in both groups;
• changes in the level of alcohol consumption (analyzed through the variables number of relapses, number of detoxifications, consumption time, abstinence time in days, number of standard drinks), comparing the baseline results with those of three and six months, in both groups;
• changes in quality of life, comparing the baseline with the results at three and six months, (World Health Organization quality of life (WHOQOL) - BREF score), in both groups.
• Performance in the cognitive domains studied, comparing the results of the baseline, three and six months between genders.

In statistical terms, univariate and bivariate descriptive analysis methodologies will be applied. In the analysis of baseline results, chi-square tests will be used to study the association of qualitative variables and t-tests for independent samples or nonparametric Mann-Whitney tests to compare two groups in quantitative variables. The aim is to compare two or three evaluation moments, using t-tests for paired samples or nonparametric Friedman tests. Additionally, for each group separately, the association between the main outcome variables and the sociodemographic characteristics of the individuals will be analyzed (applying the appropriate tests for the types of variables studied). The application of mixed ANOVA with repeated measures will be considered to compare the groups across the evaluation moments. The application of Logistic Regression will also be considered using FAB performance above or equal to the threshold of 14 as a dependent variable and associating it with potential risk and protective factors (identified as relevant by bivariate analysis). A characterization of the individuals who abandon the study (dropouts) will be performed. Whenever necessary, a significance level of 5% and a confidence level of 95% will be considered.

The study was approved by the Scientific Pedagogical Committee and the Ethics Committee for Health of the institution where it will be carried out, and by the Ethics Committee of the CAML of the Faculty of Medicine of Lisbon. Results will be disseminated in peer-reviewed publications and conference presentations.