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An open, naturalistic trial of the Inroads program, an internet-delivered early intervention to reduce anxiety and alcohol use among young people

An open trial of the self-guided Inroads intervention to reduce anxiety and alcohol use among young people

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001195943
Acronym
Inroads
Enrollment
116
Registered
2020-11-10
Start date
2021-04-21
Completion date
2023-07-22
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 str

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
17 Years to 30 Years
Healthy volunteers
No

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)

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026