N/A
N=79
AAT-App Outpatient Trial
Alcohol Use Disorder (AUD)
Bottom Line
View on ClinicalTrials.gov: NCT05120856 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Standard Drinks Consumed Per Week — 38.469; 29.645; 33.199; 28.801 standard drinks (10 grams alcohol) — p=.026
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AAT-App (Behavioral); Minimal AAT-App (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Turning Point
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Standard Drinks Consumed Per Week |
38.469; 29.645; 33.199; 28.801; 27.929; 27.957 | .026 sig |
| SECONDARY Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F) |
4.103751; 3.957517; 3.773293; 3.689666; 3.442836; 3.421814 | .633 |
| SECONDARY Severity of Dependence Scale (SDS) Scores |
7.989; 8.752; 7.404; 7.836; 6.819; 6.919 | .207 |
| SECONDARY Total Scores on the Alcohol Use Disorders Identification Test (AUDIT) |
26.897; 26.250; 14.028; 13.796 | .876 |
| SECONDARY Past-week Heavy Drinking Days (HDDs) |
2.928; 2.195; 2.602; 2.145; 2.277; 2.095 | .064 |
| SECONDARY Past-Month Drinking Days |
14.209; 11.895; 13.087; 11.245; 11.966; 10.595 | .679 |
| SECONDARY Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments |
.256; .322; .273; .325; .291; .328 | — |
| SECONDARY Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments |
.160; .224; .232; .256; .303; .288 | .403 |
| SECONDARY Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP) |
4.912; 4.709; 4.920; 4.926; 4.928; 5.144 | .161 |
| SECONDARY Approach Bias |
-69.67; -52.16; -47.01; -44.08 | .725 |
Summary
Cognitive biases contribute to the difficulty experienced by heavy drinkers wishing to reduce their alcohol use. Recent interventions designed to reduce cognitive biases demonstrate efficacy for Approach Bias Modification (ApBM). Reductions in the likelihood of relapse have been found after ApBM in Alcohol Use Disorder (AUD) patients during residential treatment. Current methods of ApBM are usually delivered by computer and joystick and come with several limitations, including accessibility. If ApBM could be shown to be feasible in other settings, such as outpatient treatment, it could benefit a much larger population with AUD.
This randomised controlled trial will test the efficacy of a recently-developed ApBM smartphone app called "AAT-App" ("Alcohol Avoidance Training App"). We aim to test whether AAT-App, relative to a minimal version of the app which excludes ApBM training, is effective at reducing alcohol use, cravings, severity of dependence, and approach bias (a measure of a person's automatic tendency to automatically approach alcohol-related stimuli), and to explore user experiences of AAT-App to guide future improvements to the app and its implementation.
Eligibility Criteria
Inclusion Criteria
- Own an Android or iOS smartphone with an Australian mobile number.
- Be currently accessing outpatient treatment for alcohol problems. Participants with multiple drugs of concern are eligible as long as alcohol is one of the drugs of concern for the current episode of treatment.
- Have an Alcohol Use Disorders Identification Test (AUDIT) score of at least 8.
Exclusion Criteria
- Any residential rehabilitation within the past 4 weeks.
- Any form of inpatient treatment (e.g. hospital or residential withdrawal treatment) within the past week.
- Scheduled to enter inpatient/residential treatment within the next month.
Data sourced from ClinicalTrials.gov (NCT05120856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.