AAT-App Trial: A Clinical Trial of a "Brain-training" Smartphone App to Help Reduce Alcohol Use in People Accessing Outpatient Alcohol Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 12
- 主要终点
- Number of Standard Drinks Consumed Per Week
研究概览
简要总结
Cognitive biases contribute to the difficulty experienced by heavy drinkers wishing to reduce their alcohol use. Recent interventions designed to reduce cognitive biases demonstrate efficacy for Approach Bias Modification (ApBM). Reductions in the likelihood of relapse have been found after ApBM in Alcohol Use Disorder (AUD) patients during residential treatment. Current methods of ApBM are usually delivered by computer and joystick and come with several limitations, including accessibility. If ApBM could be shown to be feasible in other settings, such as outpatient treatment, it could benefit a much larger population with AUD.
This randomised controlled trial will test the efficacy of a recently-developed ApBM smartphone app called "AAT-App" ("Alcohol Avoidance Training App"). We aim to test whether AAT-App, relative to a minimal version of the app which excludes ApBM training, is effective at reducing alcohol use, cravings, severity of dependence, and approach bias (a measure of a person's automatic tendency to automatically approach alcohol-related stimuli), and to explore user experiences of AAT-App to guide future improvements to the app and its implementation.
详细描述
Aims:
We aim to determine whether providing the "active" version of AAT-App (including ApBM) to people accessing outpatient alcohol treatment from AOD services, is effective, relative to a minimal version of the app which does not include ApBM training, at reducing alcohol use, cravings, and severity of dependence. We also aim to test the psychometric properties of the mobile phone approach bias measure we developed, and whether engaging in AAT-App significantly reduces approach bias, relative to the minimal control condition. We also aim to explore user experiences of AAT-App's, perceived alignment with treatment, and suggested improvements, using qualitative interviews in a subset of participants, to guide further future improvements to the app and its implementation.
Design & Setting:
We will conduct a double-blind, randomised, parallel-group controlled superiority trial with alcohol treatment outpatients in Melbourne, Victoria. Participants will be randomised to one of 2 groups with a 1:1 allocation ratio. Both participants and researchers completing the follow-up interviews will be unaware (blinded) of the condition to which they have been randomly allocated.
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and outcomes assessors will be unaware (blinded) of the condition to which participants have been randomly allocated.
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
- •Own an Android or iOS smartphone with an Australian mobile number.
- •Be currently accessing outpatient treatment for alcohol problems. Participants with multiple drugs of concern are eligible as long as alcohol is one of the drugs of concern for the current episode of treatment.
- •Have an Alcohol Use Disorders Identification Test (AUDIT) score of at least 8.
排除标准
- •Any residential rehabilitation within the past 4 weeks.
- •Any form of inpatient treatment (e.g. hospital or residential withdrawal treatment) within the past week.
- •Scheduled to enter inpatient/residential treatment within the next month.
结局指标
主要结局
Number of Standard Drinks Consumed Per Week
时间窗: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
Participants will estimate the number of standard drinks of alcohol consumed on each day within the past week, using a timeline follow-back assessment. Participants will select a number, ranging from 0-80, to estimate how many standard drinks they consumed on each day in that week. Past-week standard drinks will be calculated using the sum of values for each of the past 7 days.
次要结局
- Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)(Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use)
- Severity of Dependence Scale (SDS) Scores(Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use)
- Total Scores on the Alcohol Use Disorders Identification Test (AUDIT)(Baseline and 16 weeks after commencing app use)
- Past-week Heavy Drinking Days (HDDs)(Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use)
- Past-Month Drinking Days(Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use)
- Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments(Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use)
- Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments(Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use)
- Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)(Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, 16 weeks after commencing app use.)
- Approach Bias(Baseline and Post-Intervention (28 days after commencing app use))