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Trial registered on ANZCTR


Registration number
ACTRN12617001609347
Ethics application status
Approved
Date submitted
22/11/2017
Date registered
7/12/2017
Date last updated
23/08/2022
Date data sharing statement initially provided
21/06/2019
Date results provided
21/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Making Inroads: Trial of an online early intervention to interrupt the cycle of anxiety and drinking in young Australians
Scientific title
Making Inroads: Trial of an innovative early intervention to interrupt the cycle of anxiety and drinking in young Australians
Secondary ID [1] 291705 0
Nil
Universal Trial Number (UTN)
U1111-1195-4878
Trial acronym
Inroads
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety symptoms 302877 0
Alcohol use 302878 0
Alcohol use related harms 302879 0
Condition category
Condition code
Mental Health 302353 302353 0 0
Addiction
Mental Health 302354 302354 0 0
Anxiety

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 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.

Therapist support is provided via a weekly email with personalised feedback, trouble-shooting, and activity suggestions aligned to module content. In addition, telephone/text chat sessions following Module 1 (20-30 mins) and Module 4 (20-30 mins) will focus on motivational enhancement, developing an integrated anxiety-drinking problem formulation, trouble-shooting and tailoring behavioural experiments and cognitive therapy exercises.
Participants will also have the opportunity to submit questions or request a brief trouble-shooting session (phone/chat) via a "Therapist link up" request form. In addition, they will receive an automated email notifying them when a new module becomes accessible, and a text reminder if they have not accessed the program for 7 days. To allow some flexibility in the rate of module completion, post intervention surveys will be administered at baseline plus 8 weeks to assess short-term intervention effects, as well as 6-months post-baseline in order to examine the durability of the intervention effects.
Intervention code [1] 297789 0
Treatment: Other
Comparator / control treatment
Participants in the Inroads intervention will be compared to an alcohol information control condition. Following completion of the baseline survey, participants in the control condition will receive an alcohol information sheet including recommended NHMRC safe guidelines for alcohol use and information on the effect of alcohol and risks of overuse, as well as national telephone helplines and websites for alcohol-related problems.

Participants will complete the post-treatment surveys at 8-weeks and 6-months post-baseline. After the completion of the 6-month follow-up survey, the participants will be offered the Inroads intervention.
Control group
Active

Outcomes
Primary outcome [1] 301772 0
Alcohol consumption (total standard drinks in the past month) assessed by Timeline Follow-back.
Timepoint [1] 301772 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Primary outcome [2] 301773 0
Alcohol-related harms (past month): Assessed by the Brief Young Adult Alcohol Consequences questionnaire
Timepoint [2] 301773 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Primary outcome [3] 301774 0
Anxiety symptoms (GAD, SAD, Panic): Assessed by the GAD-7.
Timepoint [3] 301774 0
Assessed at baseline and at 8-weeks (primary time-point) and 6-months post-baseline.
Secondary outcome [1] 333820 0
Frequency of binge-drinking (past month consumption of more 5 or more standard drinks on one occasion): Assessed by Timeline Follow Back.
Timepoint [1] 333820 0
Assessed at baseline and at 8-weeks and 6-months post-baseline
Secondary outcome [2] 333821 0
Social anxiety symptoms: Assessed by the Social Phobia Scale and Social Interaction Anxiety Scale – Short form
Timepoint [2] 333821 0
Assessed at baseline and at 8-weeks and 6-months post-baseline
Secondary outcome [3] 333823 0
Anxious arousal measured by the Anxiety subscale of the Depression and Anxiety Stress Scale.
Timepoint [3] 333823 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [4] 333825 0
Depression symptoms: Measured by depression subscale of the Depression and Anxiety Stress Scale
Timepoint [4] 333825 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [5] 333826 0
Functional Impairment and quality of life will be assessed by the Sheehan disability scale.
Timepoint [5] 333826 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [6] 333827 0
Alcohol use motives: Measured by the Drinking Motives Questionnaire-Revised.
Timepoint [6] 333827 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [7] 333828 0
Positive alcohol expectancies, assessed by the Alcohol Tension-Reduction Expectancies scale
Timepoint [7] 333828 0
Assessed at baseline and at 8-weeks and 6-months post-baseline.
Secondary outcome [8] 340738 0
Emotional regulation difficulties assessed by the Managing Emotions Questionnaire
Timepoint [8] 340738 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 17-24
• 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
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Main concern related to trauma symptoms or condition other than anxiety, alcohol use or depression
• 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;
• Currently accessing psychological treatment for mental health or drug or alcohol problems
• Significant risk of complicated alcohol withdrawal

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)
Participants will be individually randomised to receive either the treatment condition (Inroads therapist-supported anxiety and alcohol intervention), or a control condition (alcohol information and guidelines leaflet). 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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power Analysis
Previous evaluations of brief, multi-session internet-delivered interventions for young adults have indicated an effect size at post-intervention of between 0.68 and 0.99 for reduction in number of drinks consumed (1,2), 0.56 for reduction in alcohol-related consequences (1), and 0.59 for reduction in anxiety symptoms (3). Optimal Design software was used to calculate the required sample size, taking into account the multi-level analysis with a nested repeated measures design (4). Using a conservative approach with intraclass correlation coefficient of 0.55 estimated based on our previous adult comorbidity trial, power calculations indicated a sample size of 90 (45 each group) would be required to detect a moderate effect size of 0.50 between the intervention and control group with power = 0.8, alpha = 0.05. To allow for data attrition at post assessment, estimated at 35%, (5) a total sample of n = 122 will be recruited to the study.

Statistical Analysis
Descriptive statistics will be conducted based on frequencies and cross-tabulations. Primary analyses will use multi-level mixed effects analysis for repeated measures (MMRM) which has a number of advantages over traditional approaches, including better treatment of missing data and flexible modelling of variance at the individual level, time effects and the within-subject covariance structure. All models will use baseline measurements as the reference point to estimate participant-specific starting points and change over time. Intervention condition will be represented by a dummy-coded variable, and the condition by time interaction was examined to assess between-group differences in treatment response over time. Treatment dose (therapist contact and module completion) will be entered as an independent variable in secondary analyses in order to examine moderation of treatment effects.

Analyses will be consistent with an intention-to-treat framework, with all randomised participants included in analysis models. 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 will be calculated from model estimated marginal means and standard errors to determine the size of effect between conditions at the relevant endpoint.

Interim descriptive analyses will be conducted following collection of baseline data. All other analyses including primary efficacy analyses will be completed after all post-treatment and 6-month follow-up assessments are finalised.


References:
1. Hustad JT, Barnett NP, Borsari B, Jackson KM. Web-based alcohol prevention for incoming college students: a randomized controlled trial. Addict Behav. 2010;35(3):183-9.
2.. Deady M, Mills KL, Teesson M, Kay-Lambkin F. An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial. Journal of medical Internet research. 2016;18(3):e71.
3. Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: A randomized controlled clinical trial. Behaviour Research and Therapy. 2013;51(7):344-51.
4. Spybrook J, Bloom H, Congdon R, Hill C, Martinez A, Raudenbush S. Optimal design plus empirical evidence: Documentation for the “Optimal Design” software. New York. : William T. Grant Foundation; 2011.
5. Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015;83(6):1108-22.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/12/2017
Actual
19/12/2017
Date of last participant enrolment
Anticipated
3/12/2018
Actual
11/09/2018
Date of last data collection
Anticipated
30/08/2019
Actual
8/04/2019
Sample size
Target
122
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296203 0
Charities/Societies/Foundations
Name [1] 296203 0
Australian Rotary Health
Country [1] 296203 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
High Street
Kensignton, NSW 2052
Country
Australia
Secondary sponsor category [1] 295111 0
University
Name [1] 295111 0
Macquarie University
Address [1] 295111 0
Balaclava Road, North Ryde
NSW, 2109, Australia
Country [1] 295111 0
Australia
Secondary sponsor category [2] 303099 0
University
Name [2] 303099 0
University of Sydney
Address [2] 303099 0
University of Sydney, NSW 2006
Country [2] 303099 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297442 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 297442 0
Ethics committee country [1] 297442 0
Australia
Date submitted for ethics approval [1] 297442 0
29/03/2017
Approval date [1] 297442 0
21/04/2017
Ethics approval number [1] 297442 0
HC17185

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74050 0
Dr Lexine Stapinski
Address 74050 0
Matilda Centre for Research in Mental Health and Substance Use
Sydney Medical School,
The University of Sydney,
Sydney, NSW 2006
Country 74050 0
Australia
Phone 74050 0
+61 2 8627 9039
Fax 74050 0
Email 74050 0
lexine.stapinski@sydney.edu.au
Contact person for public queries
Name 74051 0
Katrina Prior
Address 74051 0
Matilda Centre for Research in Mental Health and Substance Use
Sydney Medical School,
The University of Sydney
Sydney, NSW 2006
Country 74051 0
Australia
Phone 74051 0
+61 2 8627 9032
Fax 74051 0
Email 74051 0
katrina.prior@sydney.edu.au
Contact person for scientific queries
Name 74052 0
Lexine Stapinski
Address 74052 0
Matilda Centre for Research in Mental Health and Substance Use
Sydney Medical School,
The University of Sydney
Sydney, NSW 2006
Country 74052 0
Australia
Phone 74052 0
+61 2 8627 9039
Fax 74052 0
Email 74052 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
Ethics considerations given the sensitive nature of the data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2405Study protocol    https://www.researchprotocols.org/2019/4/e12370/
2406Informed consent form    https://inroads.org.au/information-consent



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAre 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.2021https://dx.doi.org/10.1016/j.eclinm.2021.101048
N.B. These documents automatically identified may not have been verified by the study sponsor.