Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000631404p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2025
Date registered
16/06/2025
Date last updated
16/06/2025
Date data sharing statement initially provided
16/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of a blended digital mental health intervention for adult anxiety
Scientific title
Randomised controlled trial to evaluate the efficacy of a blended digital mental health intervention for adult anxiety
Secondary ID [1] 314562 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 337665 0
Depression 337666 0
Condition category
Condition code
Mental Health 333996 333996 0 0
Anxiety
Mental Health 333997 333997 0 0
Depression
Mental Health 333998 333998 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The randomized controlled trial will include three arms:
1. Blended care (Arm 1): Receives Overcome Anxiety psychological therapy program and access to myNewWay app during 12-week intervention period
2. Self-guided (Arm 2): Receives access to myNewWay app during 12-week intervention period
3. Usual care control (Arm 3): Treatment as usual during 12-week intervention period.


BLENDED CARE INTERVENTION (Arm 1: Blended care)
The Overcome Anxiety blended care intervention consists of up to 10 online (telehealth) therapy sessions delivered by a psychologist (duration up to 60 minutes). All psychologists participating in the study will hold provisional or full registration as psychologists with Australian Health Practitioner Regulation Agency (AHPRA) and will have received training in using the blended care intervention with their clients. Sessions will be delivered via telehealth on Zoom or telephone over a period of up to 12 weeks. Adherence to the sessions will be monitored using attendance checklists. During the intervention period (12 weeks), Arm 1 participants will also access the myNewWay smartphone app that will supplement in-session treatment (described below). The Overcome Anxiety program is informed primarily by CBT techniques. In each session, participants will learn about key skills to manage anxiety, practice skills over the coming week, and use the smartphone app modules between therapy sessions to consolidate learning. After each session, the participant will complete activities in the smartphone app, summarising key concepts and skills practice for the content covered in the session. The blended care intervention will cover the following topics, across the 10 sessions: 1) understanding anxiety, establishing foundations for change, and goal setting, 2) understanding anxious thinking, 3) developing healthy thinking patterns, 4) overcoming overthinking, 5) facing fears, 6) managing strong emotions, 7) staying well in the long-term.

SMARTPHONE APP (Arm 1: Blended care, Arm 2: Self-guided)
myNewWay is a free Cognitive Behavioural Therapy (CBT)-based smartphone application that provides therapeutic content and symptom management strategies for adults experiencing symptoms of anxiety and/or depression. Arm 1 & 2 participants will have access to the smartphone app for the whole study duration (24 weeks). Participants will be asked to spend 10 minutes daily completing activities within the app. All activities are delivered with short informative text, the ability to select or provide free text responses and often with engaging illustrations, photos or audio exercises. App analytics will be collected (e.g., number and type of activities completed) to monitor participant engagement and adherence with the smartphone app.
The app includes over 60 brief activities that contain the key elements of evidence-based CBT for anxiety, such as psychoeducation, behavioural experiments, exposure therapy, cognitive restructuring, emotion awareness and acceptance, relaxation techniques and mindfulness. All activities are non-sequential, self-paced, take 5 to 15 minutes to complete and are grouped into 10 programs:
1. Two core programs that target anxiety (Overcome anxiety) or depression (Improve your mood)
2. Four programs focus on shared symptoms of anxiety and depression: Healthy thinking (i.e., negative thinking), Manage strong emotions (i.e., emotional regulation), Cope with overthinking (i.e., worry/rumination) and Let go of stress (i.e., body tension).
3. Four mini-programs support long-term recovery from anxiety and depression (Build confidence, Create strong relationships, Enhance mindfulness and Staying well long-term)
myNewWay also includes a daily symptom-monitoring tool that tracks mood, anxiety and sleep over time, a quick-access section with brief activities that reduce psychological distress and a Get Help section with support service contact details (e.g., Lifeline, Beyond Blue).
Intervention code [1] 331185 0
Behaviour
Comparator / control treatment
SELF-GUIDED (Arm 2)
Arm 2 participants will have access to the myNewWay app for the whole study duration (24 weeks). Participants will be asked to spend 10 minutes daily completing activities within the app.

USUAL CARE CONTROL (Arm 3) - the reference comparator group
Arm 3 participants will receive treatment as usual and be placed on a 12-week waitlist for the myNewWay app. During the 12 week waiting period, participants in this group will receive 6 brief fortnightly emails with psychoeducation about anxiety and tips about self-care. Once the 12-week waiting period is complete, Arm 3 participants will have access to myNewWay for 12 weeks. Arm 3 participants will be asked to spend 10 minutes daily completing activities within the app during this time.
Control group
Active

Outcomes
Primary outcome [1] 341658 0
Changes in self-reported anxiety symptoms
Timepoint [1] 341658 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). The primary time-point is post-treatment (12 weeks post-baseline).
Secondary outcome [1] 448232 0
Changes in depression symptoms
Timepoint [1] 448232 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [2] 448233 0
Changes in self-reported suicidality
Timepoint [2] 448233 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [3] 448234 0
Changes in social anxiety
Timepoint [3] 448234 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [4] 448235 0
Changes in health anxiety
Timepoint [4] 448235 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [5] 448236 0
Changes in panic disorder symptoms
Timepoint [5] 448236 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [6] 448237 0
Changes in anhedonia
Timepoint [6] 448237 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [7] 448238 0
Changes in self-reported sleep quality
Timepoint [7] 448238 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [8] 448239 0
Changes in wellbeing
Timepoint [8] 448239 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [9] 448240 0
Changes in quality of life
Timepoint [9] 448240 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [10] 448241 0
Changes in self-reported emotion regulation
Timepoint [10] 448241 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [11] 448242 0
Changes in self-reported general self-efficacy
Timepoint [11] 448242 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [12] 448243 0
Changes in behavioural activation and avoidance (this will be a composite outcome)
Timepoint [12] 448243 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [13] 448244 0
Changes in repetitive negative thinking
Timepoint [13] 448244 0
Baseline (Week 0), mid-treatment (Week 6), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). Secondary endpoints are post-treatment (12 weeks post-baseline) and the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [14] 448245 0
Self-reported acceptability
Timepoint [14] 448245 0
Post-treatment (week 12; blended care and self-guided groups only)
Secondary outcome [15] 448246 0
Treatment satisfaction
Timepoint [15] 448246 0
Post-treatment (12 weeks post baseline)
Secondary outcome [16] 448247 0
Usability of the myNewWay app
Timepoint [16] 448247 0
Post-treatment (Week 12; blended care & self-guided groups only).
Secondary outcome [17] 448248 0
App engagement
Timepoint [17] 448248 0
Continuous from baseline (week 0) to week 12 (post-treatment).
Secondary outcome [18] 448249 0
Self-report productivity losses
Timepoint [18] 448249 0
Baseline (Week 0), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only). The secondary endpoint is the 3-month follow-up (24 weeks post-baseline).
Secondary outcome [19] 448250 0
Self-reported health service use
Timepoint [19] 448250 0
Baseline (Week 0), post-treatment (Week 12), 3-month follow-up (Week 24; blended care & self-guided groups only).

Eligibility
Key inclusion criteria
People will be eligible for the study if they meet all of the following:
1. Score above 10 on the Distress Questionnaire 5-item (DQ-5)
2. Meet diagnostic criteria for a DSM-5 Anxiety Disorder (According to ADIS-5 diagnostic interview)
3. 18 years or older
4. Currently residing in Australia
5. Fluent in English
6. Mobile number and email address
7. Own a smartphone with a supported operating system (Apple: iOS 13 released 1999 or newer; Android: 7.0 released 2016 or newer).
8. Either not taking medications for anxiety and/or depression, or on a stable dose of medications for anxiety and/or depression (no new medications or changes in the past 8 weeks)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded from the study if they meet any of the following:
1. Aged under 18 years
2. Acutely suicidal as determined by the study psychologist
3. Experiencing a psychotic disorder
4. Currently receiving psychological therapy
5. Commencement of a new mental health medication or change in dose of existing medication in the 8 weeks prior to application

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)
There will be a two-stage screening process for confirming study eligibility. Stage 1 will involve completing an online screening questionnaire via a secure research platform, and Stage 2 will include a 30-minute phone interview with a member of the research team. Once eligibility is confirmed, the participant will be sent a link to the baseline survey for the study and, once complete, will be immediately and randomly allocated to the blended care, self-guided, or usual care group using a 1:1:1 ratio. Participants will be automatically allocated using a computerised randomisation procedure within a bespoke and secure research platform (the Black Dog Institute Research Engine). No research personnel will be involved in the randomisation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be fully automated and conducted by the Black Dog Institute Research Engine, with no interference from the research team. The participant will be informed which group they have been randomly assigned to on the last screen of the baseline survey and via an automated email and SMS. This ensures that the research team, any clinicians with the research team, and the participants remain blinded to group allocation until the allocation is revealed to the participant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE
The target sample size is 120 participants. No past RCTs have compared blended care for anxiety disorders versus a usual care control group. Therefore, our power calculations for the sample size are informed by meta-analyses of face-to-face CBT for anxiety disorders relative to usual care and studies with a similar trial design. With a large 0.8 effect size, a priori power analyses show that a minimum of 26 participants per group for blended care and the usual care group will produce a power of .8. If a 20% attrition rate is incorporated, this increases the number of participants required to be a minimum of 34/group. This has been rounded up to 40 participants/group to account for drop-out due to the trial being a longitudinal study. The same number of participants will be recruited for the self-guided group, resulting in a target sample size of 120 participants, with 40 participants allocated to each of the three trial arms.
ANALYSIS PLAN
Analyses will be undertaken on an intention-to-treat basis with all randomised participants, regardless of their group allocation or treatment received. If needed, attrition analyses will be run to check if missing data is associated with any baseline demographics (e.g., age, gender) or mental health status (e.g., symptom severity). Descriptive statistics will be calculated for cross-sectional data at baseline, 12-week, 24-week and other assessment points as needed. Linear mixed modelling will be used to analyse longitudinal questionnaire data collected via surveys. System log data from myNewWay will index participants’ app use during the trial. This data will be extracted automatically from individuals’ smartphones, transferred to the Black Dog Institute Research Engine, and downloaded and connected to participants’ study assessments using their unique participant identification code. After trial completion, the system log data will be cleaned, prepared and then analysed with descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319113 0
Government body
Name [1] 319113 0
NHMRC
Country [1] 319113 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321575 0
None
Name [1] 321575 0
Address [1] 321575 0
Country [1] 321575 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317707 0
The University of New South Wales Committee B
Ethics committee address [1] 317707 0
Ethics committee country [1] 317707 0
Australia
Date submitted for ethics approval [1] 317707 0
02/06/2025
Approval date [1] 317707 0
Ethics approval number [1] 317707 0

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

Contacts
Principal investigator
Name 141882 0
Prof Jill Newby
Address 141882 0
Black Dog Institute Hospital Rd Randwick NSW 2031
Country 141882 0
Australia
Phone 141882 0
+612 9065 9108
Fax 141882 0
Email 141882 0
[email protected]
Contact person for public queries
Name 141883 0
Dr Rosemaree Miller
Address 141883 0
Black Dog Institute Hospital Rd Randwick NSW 2031 Australia
Country 141883 0
Australia
Phone 141883 0
+612 9065 9354
Fax 141883 0
Email 141883 0
[email protected]
Contact person for scientific queries
Name 141884 0
Jill Newby
Address 141884 0
Black Dog Institute Hospital Rd Randwick NSW 2031
Country 141884 0
Australia
Phone 141884 0
+612 9065 9108
Fax 141884 0
Email 141884 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Professor Jill Newby, [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Requires ethics approval, data sharing agreement, and approval by trial custodian.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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