AAT-APP+: A Pilot RCT of a Novel Smart-phone App to Reduce Alcohol Consumption Among Middle to Older Adults in the Eastern Health Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Change in number of standard drinks past week
研究概览
简要总结
This study will explore the feasibility, acceptability, and preliminary effectiveness of a smart phone delivered form of cognitive training intervention (Approach Bias Modification (ABM)) in a non-clinical community sample of middle to older adults (>55 years) reporting hazardous alcohol use in a pilot randomised controlled trial (RCT). This app is called AAT-APP+
详细描述
Alcohol use in older adults is of particular concern, with the 55-74 year old cohort most likely to exceed lifetime alcohol risk. Approach Bias Modification (ABM) is a form of computerised cognitive training that is an efficacious intervention for alcohol use disorder. Previous studies are limited in that the stimuli are not personalised, nor are interventions readily accessible to non-treatment seeking problem drinkers. This has led to the development of a world-first, smart phone version of ABM called AAT-APP+
The current study aims to explore the feasibility, acceptability, and preliminary effectiveness of AAT-APP+ in reducing alcohol consumption and cravings in a pilot RCT with a non-clinical community sample of 100 older adults (aged 55+ years) reporting hazardous alcohol use (i.e. a score of 8+ on the AUDIT), recruited via targeted advertising. Participants in active training will upload (or select pre-selected) photos of beverages and meaningful activities, which will form the 'avoid' and 'approach' stimuli, respectively, then complete two training sessions per week for four weeks, with results compared to controls. AAT-APP+ holds promise as an innovate, cost-effective, and remotely accessible adjunctive support tool.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 55+ years
- •Score 8 or higher on the Alcohol Use Disorders Identification Test (indicates 'hazardous' levels of alcohol use).
- •Access to an Android or Apple smart phone and Australian contact number
- •Wish to reduce their drinking
- •Live within the Eastern Health Primary and Secondary Catchment (see map below)
排除标准
- •Under age 55
- •Not concerned about their drinking
- •Do not wish to reduce their alcohol use in the next 4-6 weeks
- •Do not reside with the appropriate catchment will be excluded.
- •Experiencing severe alcohol problems likely to need professional treatment (i.e. presence of withdrawal symptoms in the past year)
结局指标
主要结局
Change in number of standard drinks past week
时间窗: Change from baseline standard drinks at 4-weeks
Change from baseline in number of standard drinks at 4-weeks
次要结局
- Change in number of standard drinks consumed in the past week throughout the 4-week training program(Change from baseline standard drinks consumed in the week prior to training compared to each week of training (i.e. week 1, week 2, week 3).)
- Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)(Change from baseline craving frequency at 4-weeks)
- Approach-avoidance behaviours (approach avoidance task)(Change in alcohol approach/avoidance from baseline at 4-weeks)
- Change in number of drinking days at follow up(Change from baseline number of drinking days at 8-weeks)
- Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up)(Change from baseline craving frequency at 8-weeks)
- Approach-avoidance behaviours (alcohol approach avoidance questionnaire)(Change from baseline approach-avoidance behaviours at 4-weeks)
- Change in severity of alcohol dependence, as measured by the Severity of Dependence Scale(Change in severity of alcohol dependence at 4-weeks)
- Change in number of drinking days past week throughout the 4-week training program(Change from baseline number of drinking days in the week prior to training compared to each week of training (i.e. week 1, week 2, week 3).)
- Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up(Change from baseline approach-avoidance behaviours at 8-weeks)
- Change in number of standard drinks at follow up(Change from baseline in number of drinking days at 8 weeks)
- Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire(Change in quality of life from baseline at 4-weeks)
- Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire at follow up(Change in quality of life from baseline at 8-weeks)
- Change in subjective cognitive concerns(Change from baseline in subjective cognitive concerns at 4-weeks)
- Change in number of drinking days past week(Change from baseline drinking days at 4-weeks)
- Change in subjective cognitive concerns at follow up(Change from baseline in subjective cognitive concerns at 8-weeks)
- Change in severity of alcohol dependence (SDS) at follow up(Change in severity of alcohol dependence at 8-weeks)