NEUROPSYCHOLOGICAL REHABILITATION FOR ALCOHOL USE DISORDERS

NCT06933186 | Active Not Recruiting

• 1 other identifier: 105/21
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder Cognitive Decline

Keywords

Executive functioning; Neuropsychological Rehabilitation; Alcohol Use Disorder; Working memory; Inhibition; Cognitive Flexibility; Planning

Outcome Measures

Primary Outcomes (1)

• Frontal Assessment Battery - FAB (total score) (Lima, Meireles, Fonseca, Castro, Garrett; 2008).

  * assessment general executive functioning * divided into six subscales: abstract thinking (test of similarities); mental flexibility (phonemic fluency); motor programming (Luria motor series - fist-edge-palm patterns); sensitivity to interference (antagonistic instructions); inhibitory control (go-no-go) and environment independence (suppression of grasping behavior); * minimum score: 0; maximum score: 18; * a higher score indicates better cognitive function; * cutoff point: ≥14 (without prejudice to function).

  Baseline, one, three and six months

Secondary Outcomes (5)

• Letter-number sequence subscale of the Wechsler Adult Intelligence Scale - WAIS-III (Weschler et al, 2017)

  Baseline, three and six months

• Verbal Fluency Test (Cavaco et al, 2013a)

  Baseline, three and six months

• World Health Organization Quality of Life - BREF - WHOQOL-BREF (WHOQOL Group;1998; Skevington et al, 2004)

  Baseline, one, three and six months

• Trail Making Test - TMT (Cavaco et al, 2013)

  Baseline, three and six months

• Stroop Color and Word Test (Fernandes, 2013)

  Baseline, three and six months

Other Outcomes (4)

• Severity of Alcohol Dependence Questionnaire -SADQ (Breda et al., 2018)

  one, three and six months

• Hospital Anxiety and Depression Scale- HADS (McIntyre et al, 1999)

  one, three and six months

• Montreal Cognitive Assessment - MOCA (Simões, Freitas, Santana, Firmino, Martins, Nasreddine, Vilar; 2008)

  one moth

Study Arms (2)

Experimental Group

OTHER

This group, in addition to weekly therapeutic groups (usual treatment), will attend neuropsychological rehabilitation. This will last for 3 months, starting after alcohol detoxification, three times a week. It includes three components: cognitive training, psychoeducation and social skills/emotional management training. The cognitive training consists of 36 sessions, each lasting approximately 1h30 and will focus on the various components of EF (basic EF: working memory, inhibition, cognitive flexibility and complex functions: planning) and other cognitive domains (attention, memory, language), including different pencil and paper exercises and an online cognitive training platform Cogweb (Neuroinova, 2007), in which the exercises progress automatically through levels, becoming progressively more difficult.

Behavioral: Neuropsychological rehabilitation; Behavioral: Weekly therapeutic groups

Control Group

OTHER

The control group will attend weekly therapeutic groups, which consist of open groups, aimed to promote abstinence and relapse prevention, supporting the management of difficulties in the person's daily life related to consumption, promoting psychoeducation about the disease and coping strategies to deal with craving. At the end of the investigation, the possibility of completing the RN program will be made available to all participants in the control group, which the experimental group accessed.

Behavioral: Weekly therapeutic groups

Interventions

Neuropsychological rehabilitation BEHAVIORAL

Neuropsychological rehabilitation includes an integrated approach, consisting of three components: cognitive training; psychoeducation; and social skills/emotional management training. Cognitive training uses a combination of different tasks (always covering attention, memory and executive functions exercises), with a 30-minute session on the online cognitive training platform and 1 hour of pencil and paper exercises in a group, in a total of 36 sessions . Psychoeducation addresses specific topics related to Alcohol Use Disorder and its cognitive impact. Social skills/emotional management training includes problem-solving exercises, assertiveness training, emotion identification and management, among others. These sessions will be held once a week, for a total of 12 sessions.

Experimental Group

Weekly therapeutic groups BEHAVIORAL

The control group will attend weekly therapeutic groups, which consist of open groups, aimed to promote abstinence and relapse prevention, supporting the management of difficulties in the person's daily life related to consumption, promoting psychoeducation about the disease and coping strategies to deal with craving

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lisbon: lead
• ULSSJOSÉ: collaborator

Study Sites (1)

UTRA and Clinica 4, at ULSSJOSÉ

Lisbon, Lisbon District, 1749-002, Portugal

Location

MeSH Terms

Conditions

Alcoholism; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Sónia Ferreira, MSc

  Unidade de Tratamento e Reabilitação de Alcoólicos (UTRA), na Unidade de Local de São José. Lisboa; Faculdade de Medicina. Universidade de Lisboa.

  PRINCIPAL INVESTIGATOR

• Cristina Ribeiro, PhD

  Faculdade de Medicina. Universidade de Lisboa. Lisboa; Instituto de Medicina Preventiva e Saúde Pública. Clínica Universitária de Medicina Geral e Familiar

  STUDY CHAIR

• Samuel Pombo, PhD

  Serviço de Psiquiatria e Saúde Mental do Hospital de Santa Maria/Clinica Universitária de Psiquiatria e Psicologia Médica da Faculdade de Medicina.

  STUDY CHAIR

• Leonor Bacelar-Nicolau, PhD

  Instituto de Saúde Ambiental e Instituto de Medicina Preventiva e Saúde Pública - Faculdade de Medicina. Universidade de Lisboa.

  STUDY CHAIR

• Enrique Vásquez-Justo, PhD

  Escola Superior de Educação de Fafe. Braga. Universidad Camilo José Cela: Villafranca del Castillo, Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: To ensure that the attribution of interventions is hidden from researchers, the collaboration of a nursing member, not involved in the research, will be used to carry out the random distribution of the sample, using a random number generator, after recruitment and the first assessment. A psychologist will be included to exclusively carry out the Neuropsychological Rehabilitation program. The collection, recording, processing and analysis of data from the different phases of the research collection process will be exclusive to the researcher, and the anonymization of participants and the non-identification of group allocation will be guaranteed until the end of the research.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist- Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 18, 2025
• Study Start: September 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)