Alcohol Use DisorderNCT04923256
AAT-APP+: A Novel Brain-training App to Reduce Drinking
A study testing AAT-APP: A novel smart-phone approach-avoidance bias modification intervention in people with Alcohol Use Disorder, run by Turning Point at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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+
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- AAT-APP: A novel smart-phone approach-avoidance bias modification intervention, Sham training control
- Keywords
- Alcohol, Intervention, Cognitive Bias Modification, Mobile Health Intervention, Approach Bias
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAT-APP: A novel smart-phone approach-avoidance bias modification interventionBehavioural
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.
Sham training controlBehavioural
Complete an AAT on a weekly basis for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Approach Bias Modification | Experimental | Participants will complete 2 x 5-7 min training sessions of approach bias modification for the period of four weeks Receives: Behavioral: AAT-APP: A novel smart-phone approach-avoidance bias modification intervention |
| Control: Minimal intervention | Active comparator | Participants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks. Receives: Behavioral: Sham training control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of standard drinks past week
Change from baseline in number of standard drinks at 4-weeks
Measured: Change from baseline standard drinks at 4-weeks
Secondary outcomes (16)
Change in number of drinking days past week
Change from baseline in number of drinking days at 4-weeks
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change in severity of alcohol dependence at 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start30 Jun 2022
- Primary completion1 Apr 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turning Point
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Eastern Health
- Responsible party
- Sponsor
- Investigators
- Victoria Manning, PhD, Principal investigator, Turning Point
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923256
- Sponsor's protocol ID
- 73140
- Status last verified
- Jul 2022
- First submitted
- 11 May 2021
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04923256
- Acronym / sponsor ID
- 73140
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Intervention, Cognitive Bias Modification, Mobile Health Intervention, Approach Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Turning PointUniversity, hospital or other
- Collaborators
- Monash University, Eastern Health
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Approach Bias Modification | Experimental | Behavioral: AAT-APP: A novel smart-phone approach-avoidance bias modification interventionParticipants will complete 2 x 5-7 min training sessions of approach bias modification for the period of four weeks |
| Control: Minimal intervention | Active comparator | Behavioral: Sham training controlParticipants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAT-APP: A novel smart-phone approach-avoidance bias modification interventionParticipants 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. | Behavioural | Experimental: Approach Bias Modification |
| Sham training controlComplete an AAT on a weekly basis for four weeks | Behavioural | Control: Minimal intervention |
Primary outcome
Change in number of standard drinks past week
Time frame: Change from baseline standard drinks at 4-weeks
Change from baseline in number of standard drinks at 4-weeks
16 secondary outcomes
Change in number of drinking days past week
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline number of drinking days at 8-weeks
Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)
Time frame: Change from baseline craving frequency at 4-weeks
Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up)
Time frame: Change from baseline craving frequency at 8-weeks
Approach-avoidance behaviours (alcohol approach avoidance questionnaire)
Time frame: Change from baseline approach-avoidance behaviours at 4-weeks
Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up
Time frame: Change from baseline approach-avoidance behaviours at 8-weeks
Approach-avoidance behaviours (approach avoidance task)
Time frame: Change in alcohol approach/avoidance from baseline at 4-weeks
Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire
Time frame: 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
Time frame: Change in quality of life from baseline at 8-weeks
Change in subjective cognitive concerns
Time frame: Change from baseline in subjective cognitive concerns at 4-weeks
Change in subjective cognitive concerns at follow up
Time frame: Change from baseline in subjective cognitive concerns at 8-weeks
Change in number of standard drinks at follow up
Time frame: 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
Time frame: Change in severity of alcohol dependence at 4-weeks
Change in severity of alcohol dependence (SDS) at follow up
Time frame: Change in severity of alcohol dependence at 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Manning, PhD principal investigator
Turning Point
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAT-APP: A novel smart-phone approach-avoidance bias modification intervention in people with Alcohol Use Disorder, run by Turning Point at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of standard drinks past week (time frame: Change from baseline standard drinks at 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.