AAT-APP+: A Novel Brain-training App to Reduce Drinking

Study Overview
=================
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.

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

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Behavioral: AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
* Behavioral: Sham training control


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Approach Bias Modification<br>Participants will complete 2 x 5-7 min training sessions of approach bias modification for the period of four weeks | Behavioral: AAT-APP: A novel smart-phone approach-avoidance bias modification intervention<br>* Participants allocated to the intervention group will be required to upload photos of drinks they wish to avoid, as well as activities they wish to engage in more, and be trained to avoid and approach by repeatedly 'swiping' images away from and towards themselves, respectively.<br>|
| Active Comparator: Control: Minimal intervention<br>Participants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks. | Behavioral: Sham training control<br>* Complete an AAT on a weekly basis for four weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of standard drinks past week | Change from baseline in number of standard drinks at 4-weeks | Change from baseline standard drinks at 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of drinking days past week | Change from baseline in number of drinking days at 4-weeks | Change from baseline drinking days at 4-weeks | 
| Change in number of standard drinks consumed in the past week throughout the 4-week training program | Change from baseline in number of standard drinks at the end of each week of training (i.e. week 1, week 2, week 3) | 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). | 
| Change in number of drinking days past week throughout the 4-week training program | Change from baseline in the number of drinking days at the end of each week of training (i.e. week 1, week 2, week 3) | 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). | 
| Change in number of drinking days at follow up | Change from baseline in the number of drinking days at 8-weeks | Change from baseline number of drinking days at 8-weeks | 
| Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency) | Change from baseline craving, as measured by the Craving Experience Questionnaire, at 4-weeks. The Craving Experience Questionnaire - frequency consists of an 11-point visual analogue scale, anchored 0 = not at all, to 10 = extremely/constantly, assessing craving frequency, whereby higher scores are suggestive of greater craving frequency | Change from baseline craving frequency at 4-weeks | 
| Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up) | Change from baseline craving, as measured by the Craving Experience Questionnaire, at 8-weeks. The Craving Experience Questionnaire - frequency consists of an 11-point visual analogue scale, anchored 0 = not at all, to 10 = extremely/constantly, assessing craving frequency, whereby higher scores are suggestive of greater craving frequency | Change from baseline craving frequency at 8-weeks | 
| Approach-avoidance behaviours (alcohol approach avoidance questionnaire) | Change from baseline in self-report of approach and avoidance towards alcohol, as measured by the alcohol approach avoidance questionnaire, at 4-weeks. This is a 20-item self report measure with two primary dimensions of alcohol craving (i.e. approach and avoidance), where higher scores are suggestive of greater approach or avoidance behaviours (rated on a 9-point scale, 0 = not at all, 8 = very strongly). | Change from baseline approach-avoidance behaviours at 4-weeks | 
| Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up | Change from baseline in self-report of approach and avoidance towards alcohol, as measured by the alcohol approach avoidance questionnaire, at 8-weeks. This is a 20-item self report measure with two primary dimensions of alcohol craving (i.e. approach and avoidance), where higher scores are suggestive of greater approach or avoidance behaviours (rated on a 9-point scale, 0 = not at all, 8 = very strongly). | Change from baseline approach-avoidance behaviours at 8-weeks | 
| Approach-avoidance behaviours (approach avoidance task) | Change in alcohol approach/avoidance behaviours from baseline at 4-weeks, as calculated by([reaction time for pushing alcohol stimuli] - [reaction time for pulling alcohol related stimuli]) - ([reaction time for pushing neutral objects] - [reaction time for pulling neutral objects]). Higher positive values indicate a tendency to approach alcohol faster (i.e. faster reaction times for pulling as opposed to pushing), whereas negative values indicate a tendency to avoid alcohol (i.e. slower reactions times for pulling compared to pushing alcohol). | Change in alcohol approach/avoidance from baseline at 4-weeks | 
| Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire | Change in self report of quality of life from baseline, as measured by the quality of life items from the Australian Treatment Outcomes Profile, at 4-weeks. This is a score ranging from 0-10, whereby higher scores are indicative of greater quality of life. | 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 self report of quality of life from baseline, as measured by the quality of life items from the Australian Treatment Outcomes Profile, at 8-weeks. This is a score ranging from 0-10, whereby higher scores are indicative of greater quality of life. | Change in quality of life from baseline at 8-weeks | 
| Change in subjective cognitive concerns | Change from baseline in subjective ratings of cognitive concerns, as measured by responses to the question How concerned are you about changes in your thinking, attention, or memory skills, at 4 weeks. Participants will respond on a 5-point visual analogue scale ranging from 0 = not at all to 5 = extremely concerned, whereby higher scores indicate a greater degree of concern in relation to cognition | Change from baseline in subjective cognitive concerns at 4-weeks | 
| Change in subjective cognitive concerns at follow up | Change from baseline in subjective ratings of cognitive concerns, as measured by responses to the question How concerned are you about changes in your thinking, attention, or memory skills, at 8 weeks. Participants will respond on a 5-point visual analogue scale ranging from 0 = not at all to 5 = extremely concerned, whereby higher scores indicate a greater degree of concern in relation to cognition | Change from baseline in subjective cognitive concerns at 8-weeks | 
| Change in number of standard drinks at follow up | Change from baseline in number of drinking days at 8 weeks | Change from baseline in number of drinking days at 8 weeks | 
| Change in severity of alcohol dependence, as measured by the Severity of Dependence Scale | Change from baseline in severity of alcohol dependence, as measured by the Severity of Dependence Scale, at 4 weeks. Participants respond to five items on a 4-point scale (each scored from 0-3), with total scores ranging from 0-15 where higher scores indicate greater severity of alcohol dependence. | Change in severity of alcohol dependence at 4-weeks | 
| Change in severity of alcohol dependence (SDS) at follow up | Change from baseline in severity of alcohol dependence, as measured by the Severity of Dependence Scale, at 8-weeks. Participants respond to five items on a 4-point scale (each scored from 0-3), with total scores ranging from 0-15 where higher scores indicate greater severity of alcohol dependence. | Change in severity of alcohol dependence at 8-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, Intervention, Cognitive Bias Modification, Mobile Health Intervention, Approach Bias