Clinical trial NCT06933186: NEUROPSYCHOLOGICAL REHABILITATION FOR ALCOHOL USE DISORDERS
Official title: NEUROPSYCHOLOGICAL REHABILITATION OF EXECUTIVE FUNCTIONS IN ALCOHOL USE DISORDER: RANDOMIZED PILOT CLINICAL TRIAL PROTOCOL
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder Cognitive Decline
Keywords: Executive functioning
Neuropsychological Rehabilitation
Alcohol Use Disorder
Working memory
Inhibition
Cognitive Flexibility
Planning
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: ULSSJOSÉ
First posted: 2025-04-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Two-arm pilot clinical trial; two groups (control and experimental), with different interventions, compared at the same time, to evaluate the effectiveness of neuropsychological rehabilitation
Primary purpose: TREATMENT

Brief summary: This investigation will take place between September 2024 and June 2025, with the objective of analyzing executive deficits and the impact of Neuropsychological Rehabilitation on Alcohol Use Disorder, comparing different evaluation moments. Data will be collected at UTRA and Clinica 4, at ULSSJOSÉ, from a total of 48 participants at the end of three months, using a semi-structured interview, in order to obtain sociodemographic data and information related to alcohol consumption, as well as the application of a set of clinical and neuropsychological tests. This first assessment will be carried out after medically assisted detoxification (from the 10th day of abstinence), and subsequently the participants will be randomly distributed into two groups, a control group that will carry out the therapeutic groups (usual treatment) and a group experimental group that, in addition to these groups, will attend the Neuropsychological Rehabilitation Program. All participants will be assessed again, one, three and six months after the first assessment. This research will have the benefit of structuring interventions that are more tailored to the needs of people with AUD, seeking to minimize the impact of cognitive deficits on their physical and mental health. Participation in the study will be voluntary, and the risks for participants will be non-existent. No payment will be made to participants for their collaboration in the study. The confidentiality and anonymity of participants will be guaranteed, as well as the security of personal and clinical data, safeguarding the rights and freedoms of the data holder. The data collected will be used only for this purpose, with access to them being exclusive to the researcher, who has sole responsibility for processing and publishing the data, always seeking to preserve the identity of the participants. The data will only be kept for the time necessary to carry out the purpose of the investigation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* People who attend the Alcoholics and New Addictions Services and the Alcoholics Treatment and Rehabilitation Unit (UTRA), of the S. José Local Unit (ULSSJosé),
* undergoing medically assisted detoxification, inpatient or outpatient.
* diagnosis of PUA; be abstinent for at least 10 days; both genders;
* sign informed consent.

Exclusion Criteria:

* no indication of cognitive deterioration in the Montreal Cognitive Assessment (MOCA ≥ 26)
* severe neurological disease (stroke; traumatic brain injury; epilepsy; alcoholic dementia; Wernicke-Korsakoff condition, major neurological condition)
* severe mental disorder (psychosis; severe personality disorder);
* consumption of other toxic substances at the time of assessment;
* age under 18;
* serious physical illness;
* acute alcohol intoxication
* refusal to participate.

Primary outcomes:
measure: Frontal Assessment Battery - FAB (total score) (Lima, Meireles, Fonseca, Castro, Garrett; 2008).
timeFrame: Baseline, one, three and six months
Secondary outcomes:
measure: Letter-number sequence subscale of the Wechsler Adult Intelligence Scale - WAIS-III (Weschler et al, 2017)
timeFrame: Baseline, three and six months
measure: Verbal Fluency Test (Cavaco et al, 2013a)
timeFrame: Baseline, three and six months
measure: World Health Organization Quality of Life - BREF - WHOQOL-BREF (WHOQOL Group;1998; Skevington et al, 2004)
timeFrame: Baseline, one, three and six months
measure: Trail Making Test - TMT (Cavaco et al, 2013)
timeFrame: Baseline, three and six months
measure: Stroop Color and Word Test (Fernandes, 2013)
timeFrame: Baseline, three and six months
Other outcomes:
measure: Severity of Alcohol Dependence Questionnaire -SADQ (Breda et al., 2018)
timeFrame: one, three and six months
measure: Hospital Anxiety and Depression Scale- HADS (McIntyre et al, 1999)
timeFrame: one, three and six months
measure: Montreal Cognitive Assessment - MOCA (Simões, Freitas, Santana, Firmino, Martins, Nasreddine, Vilar; 2008)
timeFrame: one moth
measure: Sociodemographic questionnaire
timeFrame: Baseline, one, three and six months
Locations:
city: Lisbon
country: Portugal
facility: UTRA and Clinica 4, at ULSSJOSÉ
Study officials:
affiliation: Unidade de Tratamento e Reabilitação de Alcoólicos (UTRA), na Unidade de Local de São José. Lisboa; Faculdade de Medicina. Universidade de Lisboa.
name: Sónia Ferreira, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina. Universidade de Lisboa. Lisboa; Instituto de Medicina Preventiva e Saúde Pública. Clínica Universitária de Medicina Geral e Familiar
name: Cristina Ribeiro, PhD
role: STUDY_CHAIR
affiliation: Serviço de Psiquiatria e Saúde Mental do Hospital de Santa Maria/Clinica Universitária de Psiquiatria e Psicologia Médica da Faculdade de Medicina.
name: Samuel Pombo, PhD
role: STUDY_CHAIR
affiliation: Instituto de Saúde Ambiental e Instituto de Medicina Preventiva e Saúde Pública - Faculdade de Medicina. Universidade de Lisboa.
name: Leonor Bacelar-Nicolau, PhD
role: STUDY_CHAIR
affiliation: Escola Superior de Educação de Fafe. Braga. Universidad Camilo José Cela: Villafranca del Castillo, Madrid
name: Enrique Vásquez-Justo, PhD
role: STUDY_CHAIR
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