We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001195943
Ethics application status
Approved
Date submitted
29/09/2020
Date registered
10/11/2020
Date last updated
25/02/2021
Date data sharing statement initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An open, naturalistic trial of the Inroads program, an internet-delivered early intervention to reduce anxiety and alcohol use among young people
Scientific title
An open trial of the self-guided Inroads intervention to reduce anxiety and alcohol use among young people
Secondary ID [1] 302321 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
Inroads
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety symptoms 319084 0
Alcohol use 319085 0
Harms relating to alcohol use 319086 0
Condition category
Condition code
Mental Health 317035 317035 0 0
Addiction
Mental Health 317036 317036 0 0
Anxiety
Public Health 317037 317037 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Inroads intervention is an online, youth-focused, therapist-supported transdiagnostic adaptation of our effective social anxiety and alcohol disorder CBT program for adults (Stapinski, Rapee, Sannibale, Teesson, Haber & Baillie, 2015). Participants are guided through five sequential online modules over a 5-week period, with automated email and text reminders to complete program modules and monitoring of drinking and anxiety. that focus on enhancing motivation to change and developing CBT strategies to manage anxiety and alcohol use problems.

Each module should take approximately 30-60 minutes to complete, and to allow time for skill practice and consolidation, new modules will become available at a rate of 1 module each week, irrespective of whether the previous module has been completed. .

The focus of online module content is as follows:
1) Understanding patterns of alcohol use, reasons for use, and setting drinking goals, psychoeducation about cognitive, physiological and behavioural aspects of anxiety, and the inter-relationship with drinking;
2) Understanding the ABC model, cognitive therapy targeting anxious thoughts,
3) Making Choices, setting limits, and handling group dynamics;
4) Understanding avoidance and anxiety, learning techniques to manage anxiety;
5) Finding support, goal-setting and relapse prevention.

The content for each module is delivered via text, images/infographics, 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. In Modules 2,3 and 4, a brief 3-minute animated video illustrates the key skills introduced in the module (Module 2 - Realistic Thinking, Module 3 - Strategies to reduce or avoid drinking, Module 4 - Facing fears to overcome anxiety). In addition, as participants work through the program they follow the stories of two characters. This narrative is presented via audio segments (with accompanying text) 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.

In previous versions of the program, therapist support was provided via two phone sessions and a weekly email with personalised feedback, trouble-shooting, and activity suggestions aligned to module content. As recent evidence suggests that self-guided electronic health (eHealth) treatments can be just as effective as therapist-supported treatments, provided the intervention is carefully designed for self-guided delivery with features such as automatic emails (Dear et al., 2015; Carlbring et al., 2005; Berger et al., 2011; Mayo-Wilson & Montgomery 2013), we recently revised the effective Inroads program to be a fully self-guided program (i.e. without therapist support). The self-guided version of the program incorporates additional eHealth features to provide troubleshooting, accountability and motivational support via customised, responsive auto-messaging in place of therapist involvement.
Intervention code [1] 318608 0
Treatment: Other
Intervention code [2] 318609 0
Behaviour
Intervention code [3] 318610 0
Lifestyle
Comparator / control treatment
There is no control group.
The present study is a single-group open-naturalistic trial (i.e., a non-controlled clinical trial) of a 5-session cognitive behavioural therapy (CBT)-based self-guided version of the Inroads program. Effect sizes from baseline to immediately post-intervention (2-months post-baseline) and 6-months post-baseline will be compared to effect sizes in our previous randomised controlled trial of the therapist-supported version of the Inroads program.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325135 0
Hazardous drinking, assessed by the Alcohol Use Disorder Identification Test (AUDIT)
Timepoint [1] 325135 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Primary outcome [2] 325136 0
Frequency of binge-drinking (past month consumption of more 5 or more standard drinks on one occasion): Assessed by Timeline Follow Back.
Timepoint [2] 325136 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Primary outcome [3] 325137 0
Social anxiety (interaction and performance fears): Assessed by the Social Interaction Anxiety Scale SIAS-6 and the Social Phobia Scale SPS-6.
Timepoint [3] 325137 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Secondary outcome [1] 386968 0
Anxiety symptoms (GAD, SAD, Panic): Assessed by the Generalised Anxiety Disorder-7 (GAD-7)
Timepoint [1] 386968 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Secondary outcome [2] 386969 0
Alcohol consumption, assessed by Timeline Follow Back.
Timepoint [2] 386969 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [3] 386970 0
Alcohol-related harms (past month): Assessed by the Brief Young Adult Alcohol Consequences questionnaire.
Timepoint [3] 386970 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [4] 386972 0
Depression symptoms, as assessed by subscale of the Depression and Anxiety Stress Scales.
Timepoint [4] 386972 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [5] 386973 0
Worry in relation to the COVID-19 pandemic, assessed by the Matilda Centre "COVID-19 concern" measure
Timepoint [5] 386973 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [6] 386974 0
Functional Impairment assessed by the Sheehan Disability Scale
Timepoint [6] 386974 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [7] 386975 0
Anxiety about existence and the future, as assessed by total score of the Existential Anxiety Questionnaire.
Timepoint [7] 386975 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.

Eligibility
Key inclusion criteria
• Currently experiencing mild (or greater) symptoms of anxiety (General Anxiety Disorder-7 [GAD-7] >=5 or Mini-Social Phobia Inventory [Mini-SPIN] >=6), plus currently experiencing potentially risky or harmful alcohol use (Alcohol Use Disorders Identification Test [AUDIT] >=8)
• Age 17-30
• Lives in Australia
• Literate in English
• Ability to access the Internet (either in the private residence of the participant, or willingness to use the public library/other suitable venue with Internet access
• Willing to provide locator info (i.e., phone and/or address)
Minimum age
17 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Primary current concern as identified by the participant is related to trauma symptoms or substance use other than alcohol.
• Active suicidal ideation in the past two weeks (Beck Depression Inventory [BDI-II] Q9 >=2)
• Active symptoms of psychosis (Psychosis Screening Questionnaire >=3)
• Daily use of cannabis or benzodiazepines, or weekly use of psychostimulants (assessed by the National Institute on Drug Abuse quick screen questions);
• Significant risk of complicated alcohol withdrawal (indicated by past experience of severe alcohol withdrawal symptoms such as seizures, hallucinations or high fever)

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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a naturalistic trial that does not involve randomisation, no allocation concealment will be required. All participants enrolled in the trial will received the Inroads intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable, participants are not randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Sample size calculations
Power calculations were conducted to ensure adequate sample size for primary and secondary analyses. Power calculations for primary analyses and secondary moderator analyses were calculated using Optimal Design software and taking into account the multilevel analysis with a nested repeated measures design. Power calculations assumed intraclass correlation coefficients for outcomes ranging from 0.44 to 0.71 using estimates based on our previous RCT. As unguided interventions typically produce smaller effect sizes that psychologist supported interventions, estimates of within group change on outcome variables were based on previous trials of unguided multisession internet-delivered interventions for anxiety or alcohol use. Estimates of effect sizes ranged from 0.38 to 1.17 across outcomes. Power calculations indicated a sample size of 179 would be required to detect a small within group size of effect (0.38) with power=0.8 and alpha=.05. Estimates of effects of hypothesised moderators were smaller effect sizes (e.g., 0.26 for therapeutic alliance) requiring a target sample of n = 379. Sample size estimates for mediation analyses were based on simulations described by Fritz and colleagues for mediation analyses using bootstrap estimates. Assuming a moderate size of effect for the a path (based on our previous trial) and a moderate-small ß path, a target sample size of 124 would be adequate to assess mediation effects with power=0.8 and alpha=.05. To allow for data attrition at post assessment, estimated at 30% based on our previous trial, a total sample of 541 individuals (allowing for n=162 lost to follow-up) will be recruited to achieve a target sample of n = 379 and power the study for all primary and secondary analyses.

Statistical Analysis
Descriptive statistics of baseline characteristics will be conducted based on frequencies and cross-tabulations. Primary efficacy analyses will be completed after all follow-up surveys are finalised. Primary analyses will use multi-level mixed effects analysis for repeated measures (MMRM). and will apply an intention to treat (ITT) design, with all enrolled participants included in the analyses. All models will use baseline measurements as the reference point to estimate participant-specific starting points and change over time. Missing data will be accommodated in these models using maximum likelihood (ML) estimation. All models will include a random intercept and preliminary models will be estimated and model fit statistics examined to determine the most appropriate model and covariance structure. For outcomes with evidence of significant intervention effects, Cohen’s d within-group effect sizes and 95% confidence intervals will be calculated from model estimated marginal means and standard errors to determine the size of effect in terms of change on each outcome from baseline to each endpoint (2 months and 6 months post baseline).

Clinically significant change will be assessed based on criteria set out by Jacobson and Truax (1991). An estimate of clinically significant recovery or remission will be made by identifying the proportion of participants who demonstrated a significant reduction or increase in their symptoms from baseline to post test. Clinical remission will be examined by comparing baseline and follow-up alcohol and anxiety symptom measures with clinical cut-offs. We will report the proportion of participants who initially scored at or above the clinical cut-offs, and then subsequently scored below these clinical cut-offs. The first available data (i.e. baseline-observation-carried-forward; BOCF) will be carried forward for participants who did not complete post-treatment or follow-up questionnaires to provide a conservative estimate of remission.

Secondary analyses will explore moderators and mediators of treatment effects. Hypothesised moderators will be explored within the multi-level mixed effects analysis, by including a moderator by time interaction term to examine any effects of the moderator on change over time following treatment. To examine secondary hypotheses regarding mechanisms of change, mediation models incorporating outcome variable, intervention dose and hypothesised mediators will be fit using Mplus software. Using the “Model Constraint” command, new parameters and standard errors will be estimated representing causally-defined direct and indirect effects. To account for non-normality in outcome variables, standard errors and confidence intervals will be derived using 1,000 bootstrap samples.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306747 0
Government body
Name [1] 306747 0
Australian Government Department of Health
Address [1] 306747 0
Sirius Building, Furzer Street,
Woden Town Centre, ACT 2606
Country [1] 306747 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 307299 0
None
Name [1] 307299 0
Address [1] 307299 0
Country [1] 307299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306919 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306919 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 306919 0
Australia
Date submitted for ethics approval [1] 306919 0
13/04/2020
Approval date [1] 306919 0
10/08/2020
Ethics approval number [1] 306919 0
2020/319

Summary
Brief summary
This project builds on a previous randomised controlled trial (RCT), which demonstrated beneficial alcohol and anxiety outcomes compared to control following delivery of the therapist-supported "Inroads" CBT-based early intervention program. This study seeks to extend those findings to evaluate the acceptability and preliminary efficacy of a self-guided version of the Inroads program, which provides automated, personalised eHealth features in place of therapist support.


The present study will conduct a large, single-group naturalistic trial (i.e., a noncontrolled clinical trial) of a 5-session cognitive behavioural therapy (CBT)-based self-guided early intervention for anxiety and alcohol use. The self-guided version of the Inroads program incorporates additional eHealth features to provide troubleshooting, accountability and motivational support via customised, responsive auto-messaging in place of therapist involvement. In view of increasing rates of anxiety and concerning levels of binge-drinking among young Australians (AIHW 2017; Dooley et al., 2018), it is critical that we provide young people with effective tools to help them manage anxiety and alcohol use, when problematic symptoms first emerge. This is particularly important at present, as experts predict there will be further increases in the incidence and severity of anxiety and hazardous alcohol use as the result of recent and ongoing global crises, such as bushfires, droughts and the COVID-19 pandemic.

Benefits associated with the self-guided Inroads program will be measured immediately post-intervention (2-months post-baseline) to assess short-term intervention effects and at 6-months post-baseline to examine the durability of the intervention effects. Primary outcomes will include symptoms of anxiety (social anxiety, generalised anxiety) and alcohol use (frequency of binge drinking and hazardous consumption). Secondary outcomes will include alcohol consumption and negative consequences from drinking, existential anxiety and anxiety about global threats (e.g. COVID-19), depression, and functional impairment.
We hypothesise that:
1. Participants will show significant reductions in primary anxiety and alcohol use outcomes from baseline to 2-months post-baseline;
2. Participants will show sustained improvements in these outcomes until 6-month follow-up (primary end point);
3. These changes will be reflected in clinically significant improvements on alcohol and anxiety symptom measures; and
4. Participants will rate the Inroads program as acceptable.
Trial website
https://inroads.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105446 0
Dr Lexine Stapinski
Address 105446 0
Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 105446 0
Australia
Phone 105446 0
+61 2 8627 9039
Fax 105446 0
Email 105446 0
lexine.stapinski@sydney.edu.au
Contact person for public queries
Name 105447 0
Dr Lexine Stapinski
Address 105447 0
Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 105447 0
Australia
Phone 105447 0
+61 2 8627 9039
Fax 105447 0
Email 105447 0
lexine.stapinski@sydney.edu.au
Contact person for scientific queries
Name 105448 0
Dr Lexine Stapinski
Address 105448 0
Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 105448 0
Australia
Phone 105448 0
+61 2 8627 9039
Fax 105448 0
Email 105448 0
lexine.stapinski@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In view of the sensitive nature of the data collected we do not have ethics approval to share individual participant data.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 9171 0
Study protocol
Citation [1] 9171 0
Link [1] 9171 0
Email [1] 9171 0
lexine.stapinski@sydney.edu.au
Other [1] 9171 0
Attachment [1] 9171 0
Type [2] 9331 0
Statistical analysis plan
Citation [2] 9331 0
Link [2] 9331 0
Email [2] 9331 0
lexine.stapinski@sydney.edu.au
Other [2] 9331 0
Attachment [2] 9331 0
Type [3] 9332 0
Informed consent form
Citation [3] 9332 0
Link [3] 9332 0
Email [3] 9332 0
lexine.stapinski@sydney.edu.au
Other [3] 9332 0
Attachment [3] 9332 0
Type [4] 9333 0
Ethical approval
Citation [4] 9333 0
Link [4] 9333 0
Email [4] 9333 0
lexine.stapinski@sydney.edu.au
Other [4] 9333 0
Attachment [4] 9333 0
Summary results
No Results