NCT04923256

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+

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

May 11, 2021

Last Update Submit

July 29, 2025

Conditions

Keywords

AlcoholInterventionCognitive Bias ModificationMobile Health InterventionApproach Bias

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Change in number of drinking days past week

    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 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 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 number of drinking days at 8-weeks

  • Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)

    Change from baseline craving frequency at 4-weeks

  • +11 more secondary outcomes

Other Outcomes (2)

  • Task acceptability as measured by the Mobile Application Rating Scale - user version (uMARS)

    4-weeks

  • Task feasibility

    4-weeks

Study Arms (2)

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

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.

Behavioral: Sham training control

Interventions

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.

Experimental: Approach Bias Modification

Complete an AAT on a weekly basis for four weeks

Control: Minimal intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turning Point

Richmond, Victoria, 3121, Australia

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Victoria Manning, PhD

    Turning Point

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinded (Participant, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

June 11, 2021

Study Start

June 30, 2022

Primary Completion

April 1, 2023

Study Completion

March 1, 2024

Last Updated

August 1, 2025

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

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.

Locations