National Institute for Health Innovation, University of Auckland
Auckland, 1142, New Zealand
NCT Number: NCT03553056
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Auckland, 1142, New Zealand
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 6 months post-randomization
Measured by the Short Inventory of Problems - Revised (SIP-R)
Time frame: Measured at 6 months post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 3 month post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 1 month post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 2 weeks post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 6 months post-randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 3 months post-randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 1 month post-randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 2 weeks post-randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 2 weeks post-randomization
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 2 weeks post-randomization
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 2 weeks post-randomization
Time frame: Measured at 6 months post-randomization
Time frame: Measured at 3 months post-randomization
Time frame: Measured at 1 month post-randomization
Time frame: Measured at 2 weeks post-randomization
Time frame: Measured at 6 months 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.
Time frame: Measured at 3 months 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.
Time frame: Measured at 1 month 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.
Time frame: 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.
Time frame: Measured at 6 months post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 3 months post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 1 month post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 2 weeks post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 6 months post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 3 months post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 1 month post-randomization
Measured as 'Yes' or 'No'
Time frame: Measured at 2 weeks post-randomization
Measured as 'Yes' or 'No'
University of Auckland, New Zealand
Other
Acronym: NZStepAway
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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