None listed
Conditions
Brief summary
The aim of this project is to evaluate the superiority of the Inroads integrated web-based anxiety and alcohol intervention for youth, compared to an active alcohol-feedback intervention. This trial extends an earlier trial of the Inroads program combined with psychologist support (ACTRN12617001609347), which demonstrated significant reductions in hazardous alcohol use and anxiety symptoms for up to 6 months compared to an active control condition [1]. The current trial extends this work by evaluating the efficacy of an adapted, self-guided version of the Inroads anxiety and alcohol intervention, which uses rule-based response algorithms to provide feedback, troubleshooting, accountability, and motivational support via customised, auto-messaging. To maximise adherence, the web-based program will be supplemented by low intensity technical and adherence support from a non-specialist lay technician. The proposed trial will test the efficacy of the self-guided Inroads program compared to an active alcohol control intervention. In addition, the trial will address key gaps in the existing evidence-base by investigating the long-term and cost-effectiveness of the intervention, and incorporating a standardised diagnostic assessment to examine benefits of the intervention in prevention progression from hazardous drinking to alcohol use disorder. The primary aim of this trial is to evaluate the superiority of the Inroads integrated anxiety and alcohol intervention, compared to an active online alcohol-feedback intervention. Specific hypotheses are: • Concurrently targeting anxiety, alcohol use and the interrelationship between them will achieve greater reductions in anxiety symptoms and hazardous alcohol use at 2-month (primary endpoint) and 6-month follow up, compared to an active alcohol-feedback intervention. • The integrated intervention is expected to also achieve superior improvements on secondary outcomes: frequency of binge-drinking, depression symptoms, alcohol consequences and quality of life. • The integrated Inroads intervention will prevent progression to disorder, with lower rates of anxiety and alcohol use disorders at 6-month follow-up compared to alcohol-focused intervention. References: 1. Stapinski LA, Prior K, Newton NC, Biswas RK, Kelly E, Deady M, Lees B, Teesson M, Baillie AJ. Are we making Inroads? A randomized controlled trial of a psychologist-supported, web-based, cognitive behavioral therapy intervention to reduce anxiety and hazardous alcohol use among emerging adults. EClinicalMedicine. 2021
Interventions
INROADS EARLY INTERVENTION (ANXIETY AND ALCOHOL FOCUS). Participants will receive access to the Inroads program (https://inroads.org.au/), a youth-focused, transdiagnostic adaptation of our effective social anxiety and alcohol use disorder CBT program for adults [1, 2]. The Inroads intervention has been designed for delivery via the Internet and is optimised for use on smartphones/tablets. The program combines motivational enhancement with cognitive behavioural therapy (CBT) to concurrently addresses anxiety symptoms, hazardous alcohol use, and the connections between these problems. It was co-developed with the target age group, in consultations with youth service providers. The focus of module content is: 1) Understanding patterns and reasons for alcohol use, setting drinking limits, psychoeducation about cognitive, physiological and behavioural aspects of anxiety, and the inter-relationship between anxiety and drinking; 2) Introduction to cognitive therapy and application to anxious thoughts, 3) CBT strategies for sticking to drinking limits and cognitive therapy targeting positive alcohol expectancies i.e. “drinking thinking”; 4) Understanding the link between avoidance and anxiety, gradually facing fears through behavioural experiments; 5) Social support, longer-term goal-setting, and relapse prevention The content for each module is delivered via text, images/infographics, videos, and interactive forms whereby participants are guided to identify their goals, cognitive/ behavioural responses, and to practice CBT skills by working through personal examples. Additional online forms are provided for homework practice. As participants work through the program, they follow the stories of several characters, based on real-life case-studies. This narrative is presented via text (with accompanying audio segments) to illustrate case examples aligned with the key concepts or skills in each module. A 5-item quiz at the end of each module provides the opportunity for participants to test their knowledge of the key points and receive feedback on their results. Each module takes between 30-60 minutes to complete. To allow time for skill practice and knowledge consolidation, new modules will become available at the rate of 1 module per week. The post-intervention survey is administered 2 months after Inroads program delivery. After randomisation, participants have 2 months to work through the program prior to the post-intervention survey, allowing flexibility in the rate of program completion. To maximise participant engagement and adherence, Participants will receive automated email/SMS prompts to encourage completion of modules. After each module, participants will receive an email/SMS summary, with tailored feedback (generated using rule-based response algorithms) based on their responses within the modules, and suggestions to encourage practice of the skills in daily life. Email addresses will be validated to ensure accuracy at enrolment in the trial. Project staff will monitor the delivery of emails and SMS. In the case of undelivered emails, staff will automatically receive a bounce-back email, and for undelivered SMS , the SMS delivery software will send a failure notification via email. When messages are undelivered, staff will attempt to resend messages via alternate contact information, when available. In addition to automated emails and SMS, participants will receive two brief (15-30 minutes) phone calls from an “Inroads support team member” coinciding with web-based modules 1 and 4. These phone calls will be delivered by a non-clinician team member, and will follow a guideline script, focussing on trouble shooting any tech issues, encouraging module completion and practice of the key program skills. The lay technician is not permitted to give clinical advice. Lay technicians will receive training in delivery of the lay-support sessions (a half-day workshop) approximately two weeks prior to enrolment of the first participant. During the trial lay technicians will receive regular supervision from clinical psychologists . Any concerns about the participants’ wellbeing or symptom deterioration will be discussed with a clinical psychologist and if indicated, participants will receive additional follow-up by a clinician and referral to alternative support services where there is indication of risk (e.g., active suicidal intent, emergence of new symptoms that are likely to interfere with treatment). Prior to the technical support calls, participants will receive a welcome email that introduces their designated lay technician and outlines their role and the purpose of the calls. They will also be informed that they are able to contact their designated lay technician if they encounter any issues with the program and will receive a reply within 7 days. For urgent or emergency support, they will be encouraged to contact 24-hour crisis services and will be provided with a list of options. References: 1. Stapinski, L. A., Sannibale, C., Subotic, M., Rapee, R. M., Teesson, M., Haber, P. S., & Baillie, A. J. (2021). Randomised controlled trial of integrated cognitive behavioural treatment and motivational enhancement for comorbid social anxiety and alcohol use disorders. The Australian and New Zealand journal of psychiatry, 55(2), 207–220. https://doi.org/10.1177/0004867420952539 2. Stapinski, L. A., Prior, K., Newton, N. C., Biswas, R. K., Kelly, E., Deady, M., Lees, B., Teesson, M., & Baillie, A. J. (2021). Are we making Inroads? A randomized controlled trial of a psychologist-supported, web-based, cognitive behavioral therapy intervention to reduce anxiety and hazardous alcohol use among emerging adults. EClinicalMedicine, 39, 101048. https://doi.org/10.1016/j.eclinm.2021.101048
Sponsors
Study design
Eligibility
Inclusion criteria
• Australian resident • Aged 17-30 years • Currently experiencing at least mild symptoms of anxiety (social anxiety: Mini Social Phobia Inventory greater than or equal to a score of 6, or transdiagnostic/general anxiety: Generalised Anxiety Disorder-7 greater than or equal to a score of 5) • Currently reporting hazardous levels of alcohol use (Alcohol Use Disorders Identification Test score greater than or equal to a score of 8) • Willingness to give written informed consent • Willingness to comply with the study.
Exclusion criteria
• Active symptoms of psychosis (Psychosis Screening Questionnaire greater than or equal to a score of 3) • Active suicidal ideation in past two weeks • Self-identified primary concern is related to trauma symptoms or substance use other than alcohol • Significant risk of complicated alcohol withdrawal requiring medical support for detoxification • Inability or unwillingness to provide contact information (i.e. phone and address) • Insufficient English literacy • Inability to access the internet to participate in the program (either in the private residence of the participant, or willingness to use the public library/other suitable venue with Internet access) • Currently accessing ongoing psychological treatment for alcohol or anxiety • Daily use of cannabis or benzodiazepines or weekly use of psychostimulants (assessed by the National Institute on Drug Abuse quick screen questions). Participants who do not meet eligible criteria will be provided with alternative help seeking options.