Feasibility of a Smart-phone Based Support System for Hazardous Drinkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-12-07

Brief Summary

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A feasibility trial to determine whether six months access to the New Zealand 'Step Away' app can reduce the frequency of alcohol abuse and increase engagement with substance abuse-related health services by hazardous drinkers

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Detailed Description

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Rationale: Hazardous drinking is an established drinking pattern that carries a risk of harming the drinker's physical and psychological health, and/or having a harmful social effect on the drinker, their families and the community. Interventions to support people who are drinking at hazardous levels are proven to be beneficial and cost-effective at both individual and population levels. However, very few people report having received help to reduce their alcohol consumption, despite support being available. Those who do seek help predominantly talk to their GP first, who then refers them for specialist support. Consequently, there remains a significant gap between the population 'in need' of treatment and those actually engaged in treatment. Mobile-phone based alcohol interventions have the potential to function as a stand-alone intervention to help people address their alcohol problem, and/or act as a conduit to more intensive treatment. 'Step Away' is a smartphone-delivered health intervention designed in the USA to help individuals moderate or abstain completely from drinking alcohol. It is the only alcohol-related mobile app whose development was informed by an empirically-supported intervention grounded in a psychological theory. While the app has shown promise in a North American sample, a well-powered clinical trial of the intervention has yet to be undertaken. In its current form the app is not suitable for adoption in New Zealand as it uses North American drinking norms and safe drinking guidelines, numerous "Americanisms" and the imperial measurement system, and it focuses on US care services. However, a New Zealand version of 'Step Away' could easily be developed, with input from New Zealand stakeholders and end-users.

Aims: To 1) adapt the "Step Away' app for New Zealand, then 2) undertake a feasibility study to determine whether six months access to the app can reduce the frequency of alcohol abuse and increase engagement with substance abuse-related health services in adult, hazardous drinkers in Auckland.

Design: Double-blind, randomised-controlled trial.

Recruitment: Community advertising, including social media.

Sample size: As a feasibility study, no sample size calculation was undertaken. However, 200 people (100 in each arm) will provide sufficient data to ascertain the direction and likely effect size for the various alcohol-related outcomes, the likely recruitment rate, and estimates around participant retention.

Conditions

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Alcohol Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

NZ Step Away app

Group Type EXPERIMENTAL

NZ Step Away app

Intervention Type OTHER

Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)

Control

Modified NZ Step Away app

Group Type ACTIVE_COMPARATOR

Modified NZ Step Away app

Intervention Type OTHER

Access to 2 modules of the app (namely: drinkers profile and goals setting)

Interventions

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NZ Step Away app

Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)

Intervention Type OTHER

Modified NZ Step Away app

Access to 2 modules of the app (namely: drinkers profile and goals setting)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* reside in Auckland, New Zealand
* at least 18 years of age
* have access to a smartphone
* report that they currently drink alcohol
* have had at least two episodes of binge drinking (defined as six or more drinks on one occasion) in the past 30 days
* meet the criteria for hazardous drinking (i.e. 8-19 on the AUDIT)
* express motivation to moderate or abstain from drinking.

Exclusion Criteria

* Identified during screening as having moderate to severe alcohol dependence (≥20 score on the AUDIT)
* Currently enrolled in an alcohol programme
* Another person in the household is already a participant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes