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      Protocol for the Inroads Study: A Randomized Controlled Trial of an Internet-Delivered, Cognitive Behavioral Therapy–Based Early Intervention to Reduce Anxiety and Hazardous Alcohol Use Among Young People


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          The transition 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 with anxiety are at a 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 difficult-to-treat chronic problems. 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.


          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.


          A randomized controlled trial will be conducted nationally among young Australians (aged 17-24 years) 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 intervention or assessment plus alcohol guidelines. Participants randomized to the Inroads intervention will receive access to 5 Web-based cognitive behavioral therapy (CBT) modules and weekly therapist support via email and/or phone. The primary outcome assessment will be 8 weeks post baseline, with follow-up assessment 6 months post baseline to determine the sustainability of the intervention effects. Primary outcomes will be the 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). 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 analyzed by intention-to-treat using multilevel mixed effects analysis for repeated measures.


          The study is funded from 2017 to 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 published in 2020.


          The study will be the first to evaluate the benefits of a youth-focused 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 toward co-occurring anxiety and alcohol use disorders. The Web-based format of the program combined with minimal therapist support 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.

          Trial Registration

          Australian New Zealand Clinical Trials Registry ACTRN12617001609347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372748&isReview=true (Archived by WebCite at http://www.webcitation.org/77Au19jmf)

          International Registered Report Identifier (IRRID)


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          Most cited references51

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          Construction and factorial validation of a short form of the Self-Compassion Scale.

          The objective of the present study was to construct and validate a short-form version of the Self-Compassion Scale (SCS). Two Dutch samples were used to construct and cross-validate the factorial structure of a 12-item Self-Compassion Scale-Short Form (SCS-SF). The SCS-SF was then validated in a third, English sample. The SCS-SF demonstrated adequate internal consistency (Cronbach's alpha ≥ 0.86 in all samples) and a near-perfect correlation with the long form SCS (r ≥ 0.97 all samples). Confirmatory factor analysis on the SCS-SF supported the same six-factor structure as found in the long form, as well as a single higher-order factor of self-compassion. The SCS-SF thus represents a reliable and valid alternative to the long-form SCS, especially when looking at overall self-compassion scores. Copyright © 2010 John Wiley & Sons, Ltd.
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            Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry.

            The analysis of repeated-measures data presents challenges to investigators and is a topic for ongoing discussion in the Archives of General Psychiatry. Traditional methods of statistical analysis (end-point analysis and univariate and multivariate repeated-measures analysis of variance [rANOVA and rMANOVA, respectively]) have known disadvantages. More sophisticated mixed-effects models provide flexibility, and recently developed software makes them available to researchers. To review methods for repeated-measures analysis and discuss advantages and potential misuses of mixed-effects models. Also, to assess the extent of the shift from traditional to mixed-effects approaches in published reports in the Archives of General Psychiatry. The Archives of General Psychiatry from 1989 through 2001, and the Department of Veterans Affairs Cooperative Study 425. Studies with a repeated-measures design, at least 2 groups, and a continuous response variable. The first author ranked the studies according to the most advanced statistical method used in the following order: mixed-effects model, rMANOVA, rANOVA, and end-point analysis. The use of mixed-effects models has substantially increased during the last 10 years. In 2001, 30% of clinical trials reported in the Archives of General Psychiatry used mixed-effects analysis. Repeated-measures ANOVAs continue to be used widely for the analysis of repeated-measures data, despite risks to interpretation. Mixed-effects models use all available data, can properly account for correlation between repeated measurements on the same subject, have greater flexibility to model time effects, and can handle missing data more appropriately. Their flexibility makes them the preferred choice for the analysis of repeated-measures data.
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              Emerging Adulthood: What Is It, and What Is It Good For?


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                April 2019
                12 April 2019
                : 8
                : 4
                : e12370
                [1 ] Centre of Research Excellence in Mental Health and Substance Use National Drug & Alcohol Research Centre University of New South Wales Sydney Australia
                [2 ] The Matilda Centre University of Sydney Sydney Australia
                [3 ] Black Dog Institute University of New South Wales Sydney Australia
                [4 ] Faculty of Health Sciences University of Sydney Sydney Australia
                Author notes
                Corresponding Author: Lexine A Stapinski lexine.stapinski@ 123456sydney.edu.au
                Author information
                ©Lexine A Stapinski, Katrina Prior, Nicola C Newton, Mark Deady, Erin Kelly, Briana Lees, Maree Teesson, Andrew J Baillie. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 12.04.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                : 10 October 2018
                : 19 December 2018
                : 9 January 2019
                : 9 January 2019

                alcohol abuse,alcohol-related disorders,anxiety,comorbidity,early medical intervention,cognitive behavioral therapy,young adult


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