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

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
Sham training control
Sponsored by
Turning Point
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol, Intervention, Cognitive Bias Modification, Mobile Health Intervention, Approach Bias

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Turning PointRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Approach Bias Modification

Control: Minimal intervention

Arm Description

Participants will complete 2 x 5-7 min training sessions of approach bias modification for the period of four weeks

Participants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks.

Outcomes

Primary Outcome Measures

Change in number of standard drinks past week
Change from baseline in number of standard drinks at 4-weeks

Secondary Outcome Measures

Change in number of drinking days past week
Change from baseline in number of 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 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 in number of drinking days at follow up
Change from baseline in the 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
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
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).
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).
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 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, 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 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 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 in number of standard drinks at follow up
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 (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.

Full Information

First Posted
May 11, 2021
Last Updated
July 3, 2022
Sponsor
Turning Point
Collaborators
Monash University, Eastern Health
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1. Study Identification

Unique Protocol Identification Number
NCT04923256
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turning Point
Collaborators
Monash University, Eastern Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol, Intervention, Cognitive Bias Modification, Mobile Health Intervention, Approach Bias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Double blinded (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Approach Bias Modification
Arm Type
Experimental
Arm Description
Participants will complete 2 x 5-7 min training sessions of approach bias modification for the period of four weeks
Arm Title
Control: Minimal intervention
Arm Type
Active Comparator
Arm Description
Participants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks.
Intervention Type
Behavioral
Intervention Name(s)
AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham training control
Intervention Description
Complete an AAT on a weekly basis for four weeks
Primary Outcome Measure Information:
Title
Change in number of standard drinks past week
Description
Change from baseline in number of standard drinks at 4-weeks
Time Frame
Change from baseline standard drinks at 4-weeks
Secondary Outcome Measure Information:
Title
Change in number of drinking days past week
Description
Change from baseline in number of drinking days at 4-weeks
Time Frame
Change from baseline drinking days at 4-weeks
Title
Change in number of standard drinks consumed in the past week throughout the 4-week training program
Description
Change from baseline in number of standard drinks at the end of each week of training (i.e. week 1, week 2, week 3)
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).
Title
Change in number of drinking days past week throughout the 4-week training program
Description
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)
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).
Title
Change in number of drinking days at follow up
Description
Change from baseline in the number of drinking days at 8-weeks
Time Frame
Change from baseline number of drinking days at 8-weeks
Title
Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)
Description
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
Time Frame
Change from baseline craving frequency at 4-weeks
Title
Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up)
Description
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
Time Frame
Change from baseline craving frequency at 8-weeks
Title
Approach-avoidance behaviours (alcohol approach avoidance questionnaire)
Description
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).
Time Frame
Change from baseline approach-avoidance behaviours at 4-weeks
Title
Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up
Description
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).
Time Frame
Change from baseline approach-avoidance behaviours at 8-weeks
Title
Approach-avoidance behaviours (approach avoidance task)
Description
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).
Time Frame
Change in alcohol approach/avoidance from baseline at 4-weeks
Title
Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire
Description
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.
Time Frame
Change in quality of life from baseline at 4-weeks
Title
Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire at follow up
Description
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.
Time Frame
Change in quality of life from baseline at 8-weeks
Title
Change in subjective cognitive concerns
Description
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
Time Frame
Change from baseline in subjective cognitive concerns at 4-weeks
Title
Change in subjective cognitive concerns at follow up
Description
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
Time Frame
Change from baseline in subjective cognitive concerns at 8-weeks
Title
Change in number of standard drinks at follow up
Description
Change from baseline in number of drinking days at 8 weeks
Time Frame
Change from baseline in number of drinking days at 8 weeks
Title
Change in severity of alcohol dependence, as measured by the Severity of Dependence Scale
Description
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.
Time Frame
Change in severity of alcohol dependence at 4-weeks
Title
Change in severity of alcohol dependence (SDS) at follow up
Description
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.
Time Frame
Change in severity of alcohol dependence at 8-weeks
Other Pre-specified Outcome Measures:
Title
Task acceptability as measured by the Mobile Application Rating Scale - user version (uMARS)
Description
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
Time Frame
4-weeks
Title
Task feasibility
Description
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
Time Frame
4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Manning, PhD
Phone
+61384138724
Email
victoria.manning@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Georgia Bolt, MPsych
Phone
+61384138413
Email
georgia.bolt@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Manning, PhD
Organizational Affiliation
Turning Point
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turning Point
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Manning, PhD
Phone
+61384138724
Email
victoria.manning@monash.edu
First Name & Middle Initial & Last Name & Degree
Georgia Bolt, MPsych
Phone
+61384138413
Email
georgia.bolt@monash.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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