NEUROPSYCHOLOGICAL REHABILITATION OF EXECUTIVE FUNCTIONS IN ALCOHOL USE DISORDER: RANDOMIZED PILOT CLINICAL TRIAL PROTOCOL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Frontal Assessment Battery - FAB (total score) (Lima, Meireles, Fonseca, Castro, Garrett; 2008).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
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
- •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.
排除标准
- •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.
结局指标
主要结局
Frontal Assessment Battery - FAB (total score) (Lima, Meireles, Fonseca, Castro, Garrett; 2008).
时间窗: Baseline, one, three and six months
* 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).
次要结局
- Letter-number sequence subscale of the Wechsler Adult Intelligence Scale - WAIS-III (Weschler et al, 2017)(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)
- Verbal Fluency Test (Cavaco et al, 2013a)(Baseline, 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)
研究者
Sónia Ferreira
Psychologist- Principal Investigator
University of Lisbon