scholarly journals 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 (Preprint)

2018 ◽  
Author(s):  
Lexine A Stapinski ◽  
Katrina Prior ◽  
Nicola C Newton ◽  
Mark Deady ◽  
Erin Kelly ◽  
...  

BACKGROUND 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. 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 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. RESULTS 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. CONCLUSIONS 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. CLINICALTRIAL 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 REPOR DERR1-10.2196/12370

2008 ◽  
Vol 12 (05) ◽  
pp. 589 ◽  
Author(s):  
Stephanie S. O'Malley ◽  
Suchitra Krishnan-Sarin ◽  
Sherry A. McKee ◽  
Robert F. Leeman ◽  
Ned L. Cooney ◽  
...  

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022412 ◽  
Author(s):  
John A Cunningham ◽  
Christian S Hendershot ◽  
Frances Kay-Lambkin ◽  
Clayton Neighbors ◽  
Kathleen M Griffiths ◽  
...  

IntroductionHazardous alcohol consumption is common among people experiencing depression, often acting to exacerbate depressive symptoms. While many people with these co-occurring disorders do not seek face-to-face treatment, they do seek help online. There are effective internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist. In order to realise the potential of internet interventions, we need to develop an evidence base supporting the efficacy of internet interventions for co-occurring depression and hazardous alcohol use without any therapist involvement. This study aims to evaluate the effects on drinking, and on depressive symptoms, of combining an internet intervention targeting hazardous alcohol consumption with one for depression.Methods and analysisA double blinded, parallel group randomised controlled trial will be used. Participants with current depression who also drink in a hazardous fashion (n=986) will be recruited for a study to ‘help improve an online intervention for depression’. Participants will be randomised either to receive an established online intervention for depression (MoodGYM) or to receive MoodGYM plus a brief internet intervention for hazardous alcohol consumption (Check Your Drinking; CYD). Participants will be contacted 3 and 6 months after receiving the interventions to assess changes in drinking and depression symptoms. It is predicted that participants receiving the CYD intervention in addition to MoodGYM will report greater postintervention reductions in alcohol consumption and depressive symptoms compared with those who received MoodGYM only. Hypothesised mediation and moderation effects will also be investigated. Using an intention-to-treat basis for the analyses, the hypotheses will be tested using a generalised linear hypothesis framework, and longitudinal analyses will use either generalised linear mixed modelling or generalised estimating equation approach where appropriate.Ethics and disseminationThis research comprises the crucial first steps in developing lower-cost and efficacious internet interventions for people suffering from depression who also drink in a hazardous fashion—promoting the widespread availability of care for those in need. This study has been approved by the standing ethics review committee of the Centre for Addiction and Mental Health, and findings will be disseminated in the form of at least one peer-reviewed article and presentations at conferences.Trial registration numberNCT03421080; Pre-results.


2021 ◽  
Author(s):  
Katrina Prior ◽  
Elske Salemink ◽  
Reinout W Wiers ◽  
Bethany A Teachman ◽  
Monique Piggott ◽  
...  

BACKGROUND Alcohol use and anxiety disorders commonly co-occur, resulting in a more severe clinical presentation and poorer response to single-disorder treatments. Research has shown that Approach Bias Modification (ApBM) and Interpretation Bias Modification (IBM) cognitive re-training interventions can be efficacious adjunctive treatments that improve outcomes for alcohol use and social anxiety symptoms, respectively. However, the acceptability, feasibility and clinical utility of combining ApBM and IBM programs to optimise standard treatments among comorbid samples is unknown. It is also unclear as to whether integrating ApBM and IBM within each training session, or alternating them between each session, is more acceptable and efficacious. OBJECTIVE This paper describes the study protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the ‘Re-Train Your Brain’ intervention – an adjunct web-based ApBM+IBM program – among a clinical sample of emerging adults with hazardous alcohol use and social anxiety. METHODS The study involves a 3-arm randomized controlled pilot trial in which treatment-seeking emerging adults (18-30 years) with co-occurring hazardous alcohol use and social anxiety disorder symptoms will be individually randomized to receive: (1) the Re-Train Your Brain ‘integrated’ program, delivered with 10 bi-weekly sessions focusing on both social anxiety and alcohol each week (50:50 ratio), plus treatment as usual (TAU i.e., the model of care provided in accordance with standard practice at their service; n=30); (2) the Re-Train Your Brain ‘alternating’ program, delivered with 10 bi-weekly sessions focusing on social anxiety one week and alcohol the next week in an alternating pattern, plus TAU (n=30); or (3) TAU only (n=30). Primary outcomes include feasibility (uptake, follow-up rates, treatment adherence, attrition, adverse events) and acceptability (system usability, client satisfaction, user experience, training format preference). Secondary efficacy outcomes include changes in alcohol approach and interpretation biases, social anxiety symptoms, and alcohol use (e.g., average drinks per day, binge-drinking, alcohol use motives, severity of alcohol dependence, alcohol craving). The primary endpoint will be post-treatment (6 weeks post-baseline), with a secondary endpoint at 3 months post-baseline. Descriptive statistics will be conducted for primary outcomes, while intention-to-treat multi-level mixed effects analysis for repeated measures will be performed for secondary outcomes. RESULTS The study is funded from 2019―2023 by Australian Rotary Health. Recruitment is expected to be complete by mid―late 2022, with follow-ups completed by early 2023. CONCLUSIONS The study will be the first to evaluate whether an ApBM+IBM program is acceptable to treatment-seeking emerging adults and whether it is feasible to deliver it online, in settings where it will ultimately be used (e.g., at home). The findings will broaden our understanding of the types of programs that emerging adults will engage with, and whether there is preliminary evidence of it being an efficacious treatment option for this comorbidity. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001273976


2019 ◽  
Vol 42 (3) ◽  
pp. 305-313 ◽  
Author(s):  
Kyle Possemato ◽  
Emily M. Johnson ◽  
J. Bronte Emery ◽  
Michael Wade ◽  
Michelle C. Acosta ◽  
...  

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