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

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

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+

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: AAT-APP: A novel smart-phone approach-avoidance bias modification intervention; Behavioral: Sham training control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Manning, PhD; Phone Number: +61384138724; Email: victoria.manning@monash.edu
• Study Contact Backup: Name: Georgia Bolt, MPsych; Phone Number: +61384138413; Email: georgia.bolt@monash.edu

Study Locations

• Australia
  • Victoria
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Turning Point
      • Contact: Victoria Manning, PhD; Phone Number: +61384138724; Email: victoria.manning@monash.edu
      • Contact: Georgia Bolt, MPsych; Phone Number: +61384138413; Email: georgia.bolt@monash.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental: Approach Bias Modification; 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; 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.
ACTIVE_COMPARATOR: Control: Minimal intervention; Participants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks.	Behavioral: Sham training control; Complete an AAT on a weekly basis for four weeks

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task acceptability as measured by the Mobile Application Rating Scale - user version (uMARS)	Acceptability of the SWIPE app, as measured by the user version of the Mobile Application Rating Scale (uMARS). Participants will respond on a scale of 1-5, whereby higher scores indicate greater acceptability	4-weeks
Task feasibility	Feasibility of SWIPE app, as measured by recruitment and completion rates of at least 100 older adults within 6-months of advertising, with 50% of participants completing at least four sessions	4-weeks

Collaborators and Investigators

• Sponsor: Turning Point
• Collaborators: Monash University; Eastern Health
• Investigators: Principal Investigator: Victoria Manning, PhD, Turning Point

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2022
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (ACTUAL): June 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 3, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Alcohol; Intervention; Cognitive Bias Modification; Mobile Health Intervention; Approach Bias
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 73140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A layman summary of the research findings will be made available on the Turning Point website. Participants are told in the explanatory statement that if they would like to be informed of the research findings directly, they will need to contact the researchers via email. Should participants request results of research, this will be in aggregate form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No