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Trial registered on ANZCTR


Registration number
ACTRN12623000935639
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
29/08/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Nipping it in the bud: Trial of the Inroads self-guided early intervention for anxiety and drinking among young adults.
Scientific title
Nipping it in the bud: Randomised Controlled Trial (RCT) of the Inroads self-guided early intervention for anxiety and drinking among young adults.
Secondary ID [1] 309939 0
Nil known
Universal Trial Number (UTN)
U1111-1294-1298
Trial acronym
Inroads
Linked study record
This study extends a previous RCT (ACTRN12617001609347) which trialled a psychologist-supported version of the Inroads online early intervention for anxiety and drinking among young adults.

Health condition
Health condition(s) or problem(s) studied:
Anxiety symptoms 330703 0
Alcohol use 330704 0
Alcohol use related harms 330705 0
Condition category
Condition code
Mental Health 327544 327544 0 0
Addiction
Mental Health 327545 327545 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 326539 0
Treatment: Other
Intervention code [2] 326801 0
Behaviour
Comparator / control treatment
CONTROL INTERVENTION: ACTIVE ALCOHOL-FEEDBACK INTERVENTION (ALCOHOL FOCUS).
Participants in the control condition will receive personalised feedback about their alcohol use and risk level, based on the format and content of brief alcohol feedback interventions with evidence of efficacy among youth samples [1]. Using information gathered during the baseline survey, participants will also be provided with computer-generated tailored feedback about their level of drinking risk, based on scores from the Alcohol Use Disorders Identification Test for consumption (AUDIT-C)[2]. Feedback will be colour-coded (green, yellow, red) to reflect their risk level (low-risk, risky, harmful drinking, respectively). Participants will also be provided a summary of their drinking patterns, with regards to number of drinking days in the past month, number of standard drinks in the past year, total amount of money spent on alcohol in the past year, and how many calories were consumed in the past year. They will also be provided normative information about how their drinking (quantity and frequency) compares to others of a similar age (i.e., 17-30 years), and will be provided with information about alcohol-related harms, recommended NHMRC guidelines (derived from the 2020 ‘Australian Guidelines to Reduce Health Risks from Drinking’) and tips for safe alcohol use derived from a previous efficacious brief intervention [1]. They will also be provided with links to national telephone helplines and websites should they require additional or urgent support in future.

Control participants will also receive automated email/SMS reminders to complete their baseline and follow-up surveys (estimated to take 30-45 minutes at each timepoint), and prompts to access their personalised feedback and information about safe alcohol use. 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.

Reference:
1. Kypri, K., Vater, T., Bowe, S. J., Saunders, J. B., Cunningham, J. A., Horton, N. J., & McCambridge, J. (2014). Web-based alcohol screening and brief intervention for university students: a randomized trial. JAMA, 311(12), 1218–1224. https://doi.org/10.1001/jama.2014.2138
2. Bush, K., Kivlahan, D.R., McDonell, M.B. et al. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Archives of Internal Medicine, 1998. 158(16): 1789- 1795
Control group
Active

Outcomes
Primary outcome [1] 335398 0
Hazardous Drinking, assessed by the Alcohol Use Disorder Identification Test
Timepoint [1] 335398 0
Assessed at baseline and 2-months, 6-months (primary end-point), 12-months, and 18-months post baseline.
Primary outcome [2] 335399 0
Anxiety symptoms, assessed by a composite of the Social Phobia Scale and Social Interaction Anxiety Scale–short forms and the Generalised Anxiety Disorder-7. The composite Social Phobia Scale/Social Interaction Anxiety Scale measure captures anxiety symptoms for both social and performance situations. The Generalised Anxiety Disorder-7 measure captures anxiety symptoms spanning generalised anxiety, social anxiety, and panic disorder.
Timepoint [2] 335399 0
Assessed at baseline and 2-months, 6-months (primary end-point), 12-months, and 18-months post baseline.
Secondary outcome [1] 424360 0
Frequency of binge-drinking (past month consumption of >5 standard drinks on one occasion), assessed by the Timeline Follow Back procedure.
Timepoint [1] 424360 0
Assessed at baseline and 2-months, 6-months, 12-months, and 18-months post baseline.
Secondary outcome [2] 424361 0
Depression symptoms, assessed by the Depression and Anxiety Stress Scale
Timepoint [2] 424361 0
Assessed at baseline and 2-months, 6-months, 12-months, and 18-months post baseline.
Secondary outcome [3] 424362 0
Alcohol related consequences, assessed by the Brief-Young Adult Alcohol Consequence Questionnaire
Timepoint [3] 424362 0
Assessed at baseline and 2-months, 6-months, 12-months, and 18-months post baseline.
Secondary outcome [4] 424363 0
Clinical diagnosis of alcohol use disorder, as assessed by a structured diagnostic assessment, the Anxiety and Related Disorders Interview Schedule (ADIS-5), administered over the phone by trained interviewers.
Timepoint [4] 424363 0
Assessed at 6-months post baseline.
Secondary outcome [5] 424446 0
Clinical diagnosis, of any anxiety disorder (generalised anxiety disorder, social anxiety disorder, panic disorder) assessed by a structured diagnostic assessment, the Anxiety and Related Disorders Interview Schedule (ADIS-5), administered over the phone by trained interviewers.
Timepoint [5] 424446 0
Assessed at baseline and 2-months, 6-months, 12-months and 18-months post baseline
Secondary outcome [6] 424447 0
Quality of life, assessed by the Assessment of Quality of Life-4D
Timepoint [6] 424447 0
Assessed at baseline and 2-months, 6-months, 12-months and 18-months post baseline.
Secondary outcome [7] 425865 0
Mental health impact on educational/workforce participation and service utilisation, assessed by an adapted version of the Resource Use Questionnaire
Timepoint [7] 425865 0
Assessed at 6-months post baseline.

Eligibility
Key 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.
Minimum age
17 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Immediately after completely the baseline assessment, eligible participants will be individually randomised to receive either the treatment condition (Inroads self-guided anxiety and alcohol intervention), or a control condition (active alcohol-feedback). Allocation will be concealed via independent randomisation using computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be conducted independently through the trial website using a computer-generated randomisation sequence. This process removes the potential for researcher involvement.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
POWER ANALYSIS:
Expected effect sizes were drawn from our previous RCT [1], where we observed a minimum between-group effect size of d=0.35 for primary outcomes (hazardous alcohol use and anxiety composite) for the Inroads alcohol program compared to a low intensity alcohol control intervention. Given the inclusion in this trial of an alcohol feedback comparator condition with established efficacy, we conservatively power the current study for a small size of effect. Optimal Design software [2] was used to calculate the required sample size for the current trial, accounting for the multilevel analysis and assuming an intra-class correlation between nested repeated measurements of 0.66, based on our Inroads trial. This indicated a required sample size of 350 to detect a between-group effect size of d=0.30 with power=0.9 and alpha=.05. To allow for data attrition across follow-ups, estimated at 30% based on our Inroads trial, a total sample of 500 youth (250 per group) will be recruited to the study.

STATISTICAL ANALYSIS:
The primary analyses will be Mixed Models Repeated Measures (MMRM) to assess intervention effects on outcome measures within an intention-to-treat framework. Hypothesised intervention effects will be assessed by examining group by time interaction effects modelled across the 2-month and 6-month follow up assessment. Long-term sustainability of intervention effects will be assessed within secondary repeated measures mixed models once 12- and 18-month follow-ups are complete. For all analyses, missing data will be accounted for using full information maximum likelihood estimation.

Secondary analyses will examine moderators of intervention effects using MMRM analyses testing group by hypothesised moderator interaction effects. Mechanisms of change will be examined by mediation models incorporating the outcome variable, intervention condition and hypothesised mediators. Using the Mplus software “Model Constraint” command, new parameters and standard errors will be estimated representing causally defined direct and indirect effects.

Secondary analyses will also examine cost-effectiveness of the interventions. The economic evaluation will use a within-trial design analysing individual-level costs and outcomes of randomised participants across each trial arm. It will comprise both a cost-utility analysis and cost-consequences analysis, following established economic evaluation methods. The cost-utility analysis will evaluate the Inroads intervention in terms of its incremental cost per QALY gained, relative to control. The cost-consequences analysis will compare the incremental costs of the intervention to the full spectrum of outcomes included in the study (e.g., hazardous alcohol use, anxiety symptoms, etc). This will produce a dashboard summarising all relevant costs and outcomes, an approach considered useful by decision-makers. The economic evaluation will be primarily conducted using the health sector perspective, while a broader societal perspective will be implemented in a secondary analysis. Standardised economic evaluation techniques including incremental analysis of mean differences and bootstrapping to determine confidence intervals will be employed. If the intervention is found to be effective, the lifetime and population budgetary impacts of the intervention will be examined using modelling techniques.

Interim descriptive analysis and demographic profiling will be conducted following the collection of baseline data. Primary analyses will be conducted following completion of the 2- and 6-month follow-up assessment (primary-end point). Long-term follow up analyses will be conducted after each wave of follow-up data (12-months, 18-months) is finalised.

References:
1. 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
2. Spybrook. J., Bloom, H., Congdon, R., Hill, C., Martinez. A., Raudenbush. S. (2011). Optimal design plus empirical evidence: Documentation for the “Optimal Design” software. New York. : William T. Grant Foundation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/10/2023
Actual
30/10/2023
Date of last participant enrolment
Anticipated
15/08/2025
Actual
Date of last data collection
Anticipated
15/05/2027
Actual
Sample size
Target
500
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314118 0
Government body
Name [1] 314118 0
National Health and Medical Research Council (NHMRC)
Country [1] 314118 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 316267 0
None
Name [1] 316267 0
Address [1] 316267 0
Country [1] 316267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313255 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313255 0
The University of Sydney, NSW, 2006
Ethics committee country [1] 313255 0
Australia
Date submitted for ethics approval [1] 313255 0
01/05/2023
Approval date [1] 313255 0
28/06/2023
Ethics approval number [1] 313255 0
2023/348

Summary
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
Trial website
https://inroads.org.au/
Trial related presentations / publications
Public notes
Inroads Psychologist-supported Trial Paper
https://pubmed.ncbi.nlm.nih.gov/34622183/

Contacts
Principal investigator
Name 127494 0
A/Prof Lexine Stapinski
Address 127494 0
Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney,
Sydney, NSW 2006
Country 127494 0
Australia
Phone 127494 0
+61 2 8627 9039
Fax 127494 0
Email 127494 0
[email protected]
Contact person for public queries
Name 127495 0
Katrina Prior
Address 127495 0
Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney
Sydney, NSW 2006
Country 127495 0
Australia
Phone 127495 0
+61 2 8627 9032
Fax 127495 0
Email 127495 0
[email protected]
Contact person for scientific queries
Name 127496 0
Lexine Stapinski
Address 127496 0
Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney
Sydney, NSW 2006
Country 127496 0
Australia
Phone 127496 0
+61 2 8627 9039
Fax 127496 0
Email 127496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics considerations given the sensitive nature of the data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19782Study protocol    The study protocol is currently being prepared for... [More Details]
19783Informed consent form https://inroads.org.au/information-consent  Once trial is active, this link will provide the u... [More Details]
19784Ethical approval    386109-(Uploaded-24-07-2023-12-47-52)-Study-related document.pdf



Results publications and other study-related documents

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