Clinical trial NCT04923256: AAT-APP+: A Novel Brain-training App to Reduce Drinking
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol
Intervention
Cognitive Bias Modification
Mobile Health Intervention
Approach Bias
Lead sponsor: Turning Point
Sponsor class: OTHER
Collaborators: name: Monash University
name: Eastern Health
First posted: 2021-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: 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+

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in number of standard drinks past week
timeFrame: Change from baseline standard drinks at 4-weeks
Secondary outcomes:
measure: Change in number of drinking days past week
timeFrame: Change from baseline drinking days at 4-weeks
measure: Change in number of standard drinks consumed in the past week throughout the 4-week training program
timeFrame: 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).
measure: Change in number of drinking days past week throughout the 4-week training program
timeFrame: 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).
measure: Change in number of drinking days at follow up
timeFrame: Change from baseline number of drinking days at 8-weeks
measure: Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)
timeFrame: Change from baseline craving frequency at 4-weeks
measure: Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up)
timeFrame: Change from baseline craving frequency at 8-weeks
measure: Approach-avoidance behaviours (alcohol approach avoidance questionnaire)
timeFrame: Change from baseline approach-avoidance behaviours at 4-weeks
measure: Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up
timeFrame: Change from baseline approach-avoidance behaviours at 8-weeks
measure: Approach-avoidance behaviours (approach avoidance task)
timeFrame: Change in alcohol approach/avoidance from baseline at 4-weeks
measure: Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire
timeFrame: Change in quality of life from baseline at 4-weeks
measure: Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire at follow up
timeFrame: Change in quality of life from baseline at 8-weeks
measure: Change in subjective cognitive concerns
timeFrame: Change from baseline in subjective cognitive concerns at 4-weeks
measure: Change in subjective cognitive concerns at follow up
timeFrame: Change from baseline in subjective cognitive concerns at 8-weeks
measure: Change in number of standard drinks at follow up
timeFrame: Change from baseline in number of drinking days at 8 weeks
measure: Change in severity of alcohol dependence, as measured by the Severity of Dependence Scale
timeFrame: Change in severity of alcohol dependence at 4-weeks
measure: Change in severity of alcohol dependence (SDS) at follow up
timeFrame: Change in severity of alcohol dependence at 8-weeks
Other outcomes:
measure: Task acceptability as measured by the Mobile Application Rating Scale - user version (uMARS)
timeFrame: 4-weeks
measure: Task feasibility
timeFrame: 4-weeks
Locations:
city: Richmond
country: Australia
facility: Turning Point
state: Victoria
Study officials:
affiliation: Turning Point
name: Victoria Manning, PhD
role: PRINCIPAL_INVESTIGATOR
References: