Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 10, 2018
Open Peer Review Period: Oct 25, 2018 - Nov 8, 2018
Date Accepted: Jan 9, 2019
(closed for review but you can still tweet)
Making Inroads: Protocol for a randomized controlled trial of an online early intervention to address anxiety and alcohol use among young people
ABSTRACT
Background:
The transition from adolescence to adulthood is a unique developmental period, characterized by numerous personal and social role changes, and increased opportunities for alcohol consumption. Using alcohol to cope with anxiety symptoms is commonly reported, and young people who experience anxiety are at greater risk of hazardous alcohol use and progression to alcohol use disorder. Anxiety and alcohol use tend to fuel each other in an exacerbating feed-forward cycle, leading to chronic problems that are difficult to treat. The peak in onset of anxiety and alcohol disorders suggests this developmental window represents a promising opportunity for early intervention, before these problems become entrenched.
Objective:
This study aims to evaluate the efficacy of the Inroads program, a therapist-supported, internet-delivered early intervention for young adults that targets alcohol use, anxiety symptoms, and the interconnections between these problems.
Methods:
A randomized controlled trial will be conducted nationally across Australia among young adults (aged 17-24) who experience anxiety symptoms and drink alcohol at hazardous or harmful levels. Participants will be individually randomized on a 1:1 basis to receive the Inroads early intervention or assessment plus alcohol guidelines and information. Participants randomized to the Inroads intervention will receive access to five online Cognitive Behavioral Therapy (CBT) modules and weekly therapist support via email or phone. The primary endpoint for outcome assessment will be 8 weeks post-baseline, with follow-up assessment 6 months post-baseline to determine sustainability of the intervention effects. Primary outcomes will be total number of standard drinks consumed in the past month (assessed by the Timeline Follow-back Procedure), severity of alcohol-related harms (assessed by the Brief Young Adult Alcohol Consequences questionnaire), and anxiety symptoms across multiple disorders (assessed by the Generalized Anxiety Disorder-7 Questionnaire). Secondary outcomes will include alcohol outcome expectancies, functional impairment and quality of life, and symptoms of social anxiety, anxious arousal and depression. Results will be analysed by intention-to-treat using multi-level mixed effects analysis for repeated measures.
Results:
The study is funded from 2017-2020 by Australian Rotary Health. Recruitment is expected to be complete by late 2018, with the 6-month follow-ups to be completed by mid-2019. Results are expected to be submitted for publication in 2020.
Conclusions:
The study will be the first to evaluate the benefits of a youth-focussed early intervention that simultaneously targets anxiety and hazardous alcohol use. By explicitly addressing the interconnections between anxiety and alcohol use, and enhancing CBT coping skills, the Inroads program has the potential to interrupt the trajectory towards co-occurring anxiety and alcohol use disorders. The online format of the program combined with minimal therapist support via phone/email/chat means that if effective, the program could be widely disseminated to reach young people who are not currently able or willing to access face-to-face treatment. Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001609347.
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.