AAT-App Outpatient Trial

NCT05120856 | Completed Results

• 1 other identifier: ADRIA045
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Approach Bias Modification; Alcohol; Alcohol Use Disorder; Addiction; Cognitive Bias Modification; mHealth; Smartphone App

Outcome Measures

Primary Outcomes (1)

• Number of Standard Drinks Consumed Per Week

  Participants will estimate the number of standard drinks of alcohol consumed on each day within the past week, using a timeline follow-back assessment. Participants will select a number, ranging from 0-80, to estimate how many standard drinks they consumed on each day in that week. Past-week standard drinks will be calculated using the sum of values for each of the past 7 days.

  Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Secondary Outcomes (9)

• Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)

  Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

• Severity of Dependence Scale (SDS) Scores

  Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

• Total Scores on the Alcohol Use Disorders Identification Test (AUDIT)

  Baseline and 16 weeks after commencing app use

• Past-week Heavy Drinking Days (HDDs)

  Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

• Past-Month Drinking Days

  Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use

Study Arms (2)

Active AAT-App

EXPERIMENTAL

Participants will receive the active AAT-App.

Behavioral: AAT-App

Minimal AAT-App

SHAM COMPARATOR

Participants will receive the minimal version of AAT-App.

Behavioral: Minimal AAT-App

Interventions

AAT-App BEHAVIORAL

Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.

Active AAT-App

Minimal AAT-App BEHAVIORAL

Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.

Minimal AAT-App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turning Point: lead
• Monash Health: collaborator
• St Vincent's Hospital Melbourne: collaborator
• Uniting Vic Tas: collaborator
• Star Health: collaborator
• Odyssey House: collaborator

Study Sites (6)

Uniting Vic Tas

Coburg, Victoria, 3058, Australia

Location

Monash Health (Addiction Medicine Unit)

Dandenong, Victoria, 3175, Australia

Location

St. Vincent's Hospital Melbourne (Department of Addiction Medicine)

Fitzroy, Victoria, 3065, Australia

Location

Odyssey House Victoria

Richmond, Victoria, 3121, Australia

Location

Turning Point

Richmond, Victoria, 3121, Australia

Location

Star Health

South Melbourne, Victoria, 3205, Australia

Location

Related Publications (7)

• Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.

  PMID: 23218805 BACKGROUND

• Manning V, Staiger PK, Hall K, Garfield JB, Flaks G, Leung D, Hughes LK, Lum JA, Lubman DI, Verdejo-Garcia A. Cognitive Bias Modification Training During Inpatient Alcohol Detoxification Reduces Early Relapse: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2016 Sep;40(9):2011-9. doi: 10.1111/acer.13163. Epub 2016 Aug 4.

  PMID: 27488392 BACKGROUND

• Manning V, Garfield JBB, Staiger PK, Lubman DI, Lum JAG, Reynolds J, Hall K, Bonomo Y, Lloyd-Jones M, Wiers RW, Piercy H, Jacka D, Verdejo-Garcia A. Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Feb 1;78(2):133-140. doi: 10.1001/jamapsychiatry.2020.3446.

  PMID: 33146693 BACKGROUND

• Rinck M, Wiers RW, Becker ES, Lindenmeyer J. Relapse prevention in abstinent alcoholics by cognitive bias modification: Clinical effects of combining approach bias modification and attention bias modification. J Consult Clin Psychol. 2018 Dec;86(12):1005-1016. doi: 10.1037/ccp0000321.

  PMID: 30507226 BACKGROUND

• Salemink E, Rinck M, Becker E, Wiers RW, Lindenmeyer J. Does comorbid anxiety or depression moderate effects of approach bias modification in the treatment of alcohol use disorders? Psychol Addict Behav. 2022 Aug;36(5):547-554. doi: 10.1037/adb0000642. Epub 2021 Jun 10.

  PMID: 34110839 BACKGROUND

• Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.

  PMID: 21389338 BACKGROUND

• Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006; 3(2): 77-101.

  BACKGROUND

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Results Point of Contact

• Title: Dr Joshua B. B. Garfield
• Organization: Monash University

joshuag@turningpoint.org.au

+61 3 8413 8711

Study Officials

• Victoria Manning

  Turning Point

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcomes assessors will be unaware (blinded) of the condition to which participants have been randomly allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind, randomised, parallel-group controlled superiority trial with alcohol treatment outpatients will be conducted. Participants will be randomised to one of 2 groups with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 15, 2021
• Study Start: May 25, 2022
• Primary Completion: February 21, 2024
• Study Completion: May 15, 2024
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Researchers interested in accessing individual participant data may contact the coordinating principal investigator after the primary outcome has been published. Note that data will only be stored for 7 years following publication of the last peer-reviewed publication arising from this study, or 7 years after the final report to the ethics committee, or 7 years after final reporting of outcomes on the clinical trials registry, whichever occurs latest. After this 7 year retention period, individual participant data may not be available.
• Access Criteria: Reasonable requests to access individual participant data will be considered by the coordinating principal investigator

Locations

AU (6)