跳至主要内容
临床试验/NCT06470698
NCT06470698招募中不适用

Neuropsychological Assessment in Real Time of the Implicit Cognition in the Prediction of Relapse of Patients With Substance Use Disorder

University of Huelva1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
Differences between daily access scores and temptation access scores

研究概览

简要总结

This longitudinal repeated measures study will evaluate participants at the beginning of treatment through an assessment of psychological measures and craving. They will be trained to use a mobile platform, which will be available for 12 days. The assessment will be conducted via Ecological Momentary Assessment (EMA), with scheduled daily access and during situations of consumption risk. Each access will include questions on substance use, depression, anxiety, triggering situations, attitude towards drugs, and a cognitive bias test. The platform will alternate between two tests (Drug Stroop Task and WAT-DUD). Participants will follow a treatment program supervised by professionals.

The study aims to recruit 130 participants (65 for alcohol, 65 for cocaine) from the Provincial Service for Drug Dependence and Addictions in Huelva (SPDA). Participants, selected via stratified random sampling, must reside in Huelva, sign informed consent, have a compatible mobile device, and be over 18. Anonymity will be ensured through alphanumeric codes.

Upon treatment admission, selected patients will be informed of their participation in the study. Interviews, conducted by psychologists, will outline the study objectives and duration. Patients agreeing to participate will sign informed consent and receive an identification code. Baseline assessment data will be integrated into a database for subsequent statistical analysis. The assessment encompasses the collection of four blocks of information:

Block 1. Patients medical history initiated during treatment admission. Block 2. Neuropsychological battery developed by the research team for the baseline evaluation.

Block 3. Neuropsychological battery developed by the research team for the web platform measured through Ecological Momentary Assessment (EMA).

Block 4. Follow-up information at three and six months provided by SPDA professionals through the patients medical history.

To ensure compliance with participant follow-up, a mixed monitoring protocol has been developed, which includes phone calls and WhatsApp messages. This protocol is designed according to social exchange theory so that participants perceive the benefits of their participation as outweighing the costs.

The statistical analysis involves identifying outliers and trimming distributions. Data will be averaged per test per person, considering different conditions. Repeated measures ANOVA will analyze factors such as gender and substance type to address study objectives, examining interactions and conducting planned contrasts for specific comparisons.

详细描述

  1. Study design: Longitudinal study of repeated measures in which: 1) Participants will undergo a baseline assessment at the beginning of treatment, which will include psychological measures and craving assessment. During this session, they will be logged into a platform via their mobile devices and trained in its use. The platform will be available from this moment onwards and for the next 12 days. 2) At this point, the assessment begins through ecological momentary assessment (EMA). Participants will be required to access the platform once daily during a pre-set time window (Daily Assessment; DA). Participants will also be instructed to access the platform when they experience they are at risk of consuming or acquiring substances (Temptation Assessment; TA). Each access to the platform, whether DA or TA, will include questions assessing substance use, depression, subjective anxiety, triggering situations, attitude toward drugs, and a cognitive bias test. The application will be programmed to administer one of two cognitive bias tests (Drug Stroop Task and WAT-DUD) in an alternate sequence for each participant, so that each test is administered 6 times to each subject (complete within-subjects counterbalancing). Throughout the entire study and during the subsequent months, participants will engage in a substance use treatment program, and clinical professionals from the Provincial Centers for Drug Dependence and Addictions will monitor patients to prevent and/or treat potential relapses.
  2. Participants: The study targets to recruit 130 participants (65 for alcohol, 65 for cocaine) who are receiving treatment for substance use disorder at the Provincial Service for Drug Dependence and Addictions in the province of Huelva (SPDA). The sample will be selected through stratified random sampling with simple allocation based on the primary drug of consumption and gender. To anonymize participant information, the application will not collect personal data. Participants will be assigned an alphanumeric code for identification.
  3. Procedures: At the time of admission to treatment, professionals at addiction treatment centers will inform randomly selected patients that they have been chosen to participate in this study. If they agree to participate, the interview will commence in a designated room at these centers where the psychologist administering the tests will be present. At the outset of the interview, participants will be briefed on the project objectives, duration, and its independent nature from their treatment process, and will be asked if they are interested in participating. In the event that the patient agrees, they will be asked to sign the informed consent form. Additionally, they will be assigned a code that will only allow their identification by the research team personnel, in order to incorporate the gathered information into follow-up assessments. Upon completion of the baseline assessment tests, all data will be integrated with psychological and neuropsychological tests into a database for subsequent statistical analysis. This database will not contain any information enabling patient identification by individuals not involved in the research.

The assessment encompasses the collection of four blocks of information:

Block 1. Patients medical history initiated during treatment admission. The following information will be gathered:

a) Consumption pattern during the 30 days prior to treatment initiation b) Sociodemographic information collected by center professionals.

Block 2. Neuropsychological battery developed by the research team for the baseline evaluation. The estimated time is 90 minutes, including training in the use of the platform. The following tests will be used:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients initiating treatment for addiction to cocaine or alcohol as the primary substance.
  • Patients with a diagnosis of Substance Use Disorder of mild, moderate, or severe severity, according to the 5th Edition of the DSM (Diagnostic and Statistical Manual of Mental Disorders).
  • Maintaining residency in the province of Huelva during the study's follow-up period.
  • Willingness to participate in the study by providing informed consent.
  • Possessing a mobile device that meets the necessary technical requirements for the installation and operation of the application.

排除标准

  • Patients with severe, unstable mental disorders, as assessed by the clinical team at the treatment centers.
  • Patients with physical or mental disorders that hinder the execution of the tests and assessments included in the study.
  • Patients under the age of
  • Patients with opioid consumption.

结局指标

主要结局

Differences between daily access scores and temptation access scores

时间窗: Through study completion, an average of 2 years

We may find statistically significant differences between the scores obtained during episodes of temptation to consume or purchase substances and those obtained from daily measures, with higher scores during temptation episodes. These differences will be observed in both groups, among both men and women.

Relationship between number of episodes of temptations and scores in the tests

时间窗: Through study completion, an average of 2 years

It may be that during the monitoring, those participants who experience a higher number of episodes of temptation will have elevated levels in the scheduled measures. Those participants who have higher scores during episodes of temptation will have a greater number of episodes of consumption. These relationships will be observed in both groups, among both men and women.

Differences based on the type of substance

时间窗: Through study completion, an average of 2 years

There may be statistically significant differences in the test scores based on the type of substance.

Relationship between the studied variables and variables associated with gender.

时间窗: Through study completion, an average of 2 years

We may find differences in test scores based on gender-related variables.

次要结局

未报告次要终点

研究者

发起方
University of Huelva
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrique Moraleda Barreno

Principal Investigator

University of Huelva

研究点 (1)

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