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

Not Applicable

Completed

• Conditions: Alcohol Consumption

• Registration Number: NCT03553056
• Lead Sponsor: University of Auckland, New Zealand

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-06-10
• Study First Posted: 2018-06-12
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days spent hazardously drinking in the last 30 days	Measured at 6 months post-randomization

Secondary Outcome Measures

Name	Time	Method
Drinking-related problems	Measured at 6 months post-randomization	Measured by the Short Inventory of Problems - Revised (SIP-R)
Percentage of days spent hazardously drinking in the last 30 days	Measured at 1 month post-randomization
App utlization	Measured at 2 weeks post-randomization
Number of days spent hazardously drinking in the last 30 days	Measured at 1 month post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured at 2 weeks post-randomization	Measured as 'Yes' or 'No'
Drinks per day over the last 30 days	Measured at 1 month post-randomization
Any contact with substance abuse-related health services since randomization	Measured at 2 weeks post-randomization	Measured as 'Yes' or 'No'
Withdrawal from study	Measured at 2 weeks post-randomization
Alcohol withdrawal	Measured at 2 weeks post-randomization	Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Who they have talked to about their drinking, since randomization	Measured at 2 weeks post-randomization	'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Serious adverse events	Measured at 2 weeks post-randomization
Loss to follow-up	Measured at 2 weeks post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured at 2 weeks post-randomization	Measured as 'Yes' or 'No'
Any contact with substance abuse-related health services since randomizations	Measured at 3 month post-randomization	Measured as 'Yes' or 'No'

Trial Locations

Locations (1)

National Institute for Health Innovation, University of Auckland; 🇳🇿 Auckland, New Zealand