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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
114
Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)
Access to 2 modules of the app (namely: drinkers profile and goals setting)
National Institute for Health Innovation, University of Auckland
Auckland, New Zealand
Number of days spent hazardously drinking in the last 30 days
Time frame: Measured at 6 months post-randomization
Number of days spent hazardously drinking in the last 30 days
Time frame: Measured at 3 months post-randomization
Number of days spent hazardously drinking in the last 30 days
Time frame: Measured at 1 month post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Time frame: Measured at 6 months post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Time frame: Measured at 3 months post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Time frame: Measured at 1 month post-randomization
Drinks per day over the last 30 days
Time frame: Measured at 6 months post-randomization
Drinks per day over the last 30 days
Time frame: Measured at 3 months post-randomization
Drinks per day over the last 30 days
Time frame: Measured at 1 month post-randomization
Drinking-related problems
Measured by the Short Inventory of Problems - Revised (SIP-R)
Time frame: Measured at 6 months post-randomization
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Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomizations
Measured as 'Yes' or 'No'
Time frame: Measured at 3 month post-randomization
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 1 month post-randomization
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 2 weeks post-randomization
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 6 months post-randomization
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 3 months post-randomization
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 1 month post-randomization
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 2 weeks post-randomization
Serious adverse events
Time frame: Measured at 6 months post-randomization
Serious adverse events
Time frame: Measured at 3 months post-randomization
Serious adverse events
Time frame: Measured at 1 month post-randomization
Serious adverse events
Time frame: Measured at 2 weeks post-randomization
App utlization
Time frame: Measured at 6 months post-randomization
App utlization
Time frame: Measured at 3 months post-randomization
App utlization
Time frame: Measured at 1 month post-randomization
App utlization
Time frame: Measured at 2 weeks post-randomization
Withdrawal from study
Time frame: Measured at 6 months post-randomization
Withdrawal from study
Time frame: Measured at 3 months post-randomization
Withdrawal from study
Time frame: Measured at 1 month post-randomization
Withdrawal from study
Time frame: Measured at 2 weeks post-randomization
Loss to follow-up
Time frame: Measured at 6 months post-randomization
Loss to follow-up
Time frame: Measured at 3 months post-randomization
Loss to follow-up
Time frame: Measured at 1 month post-randomization
Loss to follow-up
Time frame: Measured at 2 weeks post-randomization
Alcohol withdrawal
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.
Time frame: Measured at 6 months post-randomization
Alcohol withdrawal
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.
Time frame: Measured at 3 months post-randomization
Alcohol withdrawal
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.
Time frame: Measured at 1 month post-randomization
Alcohol withdrawal
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.
Time frame: Measured at 2 weeks post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 6 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 3 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 1 month post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 2 weeks post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 6 months post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 3 months post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 1 month post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Time frame: Measured at 2 weeks post-randomization