Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000637448p
Ethics application status
Submitted, not yet approved
Date submitted
20/05/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Trial of a Transdiagnostic Blended Care Group for Anxiety in Adults
Scientific title
Pilot Trial of the Effect of a Transdiagnostic Blended Care Group for Anxiety in Adults
Secondary ID [1] 314488 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 337527 0
Social anxiety disorder 337528 0
Illness anxiety disorder 337529 0
Panic Disorder 337530 0
Condition category
Condition code
Mental Health 333895 333895 0 0
Anxiety
Mental Health 333896 333896 0 0
Depression
Mental Health 333995 333995 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The transdiagnostic blended care group program will comprise of 8 sessions across 8 weeks, delivered via telehealth, by psychologists. The program is derived by cognitive behavioural therapy and includes psychoeducation about anxiety and management of physical symptoms of anxiety, graded exposure to overcome avoidance, behavioural experiments to test maladaptive beliefs, thought challenging to address unhelpful thoughts, communication skills to address assertiveness, distress tolerance, mindfulness and acceptance, and relapse prevention. Each week a new module will be presented during the group session and each session will take approximately 90 minutes. Participants will also have access to a smartphone application, myNewWay, and the group sessions have been designed to refer to activities and exercises in myNewWay for the participants to use the app in their own time between sessions. Participants will be encouraged to use the app between sessions to consolidate learning and practice new skills introduced during the group sessions.
Participants will complete a measure of anxiety prior to the first weekly session, during week 4, and at the completion of the 8 weeks. Participants will also complete measures of social anxiety, panic, illness anxiety, depression, work and social functioning, and self-efficacy prior to the first week, during week 4, and at the completion of the 8 weeks. A group session rating scale and a measure of psychological distress will be completed each week by participants. These weekly scores will be monitored by clinicians and if a participant has an elevated score of distress, if it is clinically justified, the clinician may communicate with the participant to determine if additional support is needed.
Strategies used to improve adherence to the intervention procedures include: automated email reminders, and verbal check-ins at each group session.
Intervention code [1] 331111 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341538 0
Changes in generalised anxiety symptoms
Timepoint [1] 341538 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8). Primary time-point is post-treatment.
Secondary outcome [1] 447877 0
Changes in depression symptoms
Timepoint [1] 447877 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
Secondary outcome [2] 447878 0
Changes in social anxiety symptoms.
Timepoint [2] 447878 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
Secondary outcome [3] 447879 0
Changes in panic symptoms
Timepoint [3] 447879 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
Secondary outcome [4] 447880 0
Changes in illness anxiety symptoms
Timepoint [4] 447880 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
Secondary outcome [5] 447881 0
Changes in perceived self-efficacy
Timepoint [5] 447881 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
Secondary outcome [6] 447882 0
Changes in perceived functioning
Timepoint [6] 447882 0
Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
Secondary outcome [7] 447913 0
Changes in depression symptoms
Timepoint [7] 447913 0
Baseline (week 0), each week during treatment phase (week 0 to week 8).
Secondary outcome [8] 447914 0
Changes in anxiety symptoms
Timepoint [8] 447914 0
Baseline (week 0), each week during treatment phase (week 0 to week 8).
Secondary outcome [9] 447915 0
Changes in stress symptoms
Timepoint [9] 447915 0
Baseline (week 0), each week during treatment phase (week 0 to week 8).
Secondary outcome [10] 447916 0
Change in satisfaction with group program
Timepoint [10] 447916 0
Each week during treatment phase (week 0 to week 8).
Secondary outcome [11] 447917 0
Treatment acceptability
Timepoint [11] 447917 0
Post-treatment (week 8)
Secondary outcome [12] 447918 0
Treatment satisfaction
Timepoint [12] 447918 0
Post-treatment (week 8)
Secondary outcome [13] 447919 0
Client engagement (app usage)
Timepoint [13] 447919 0
Continuously from baseline (week 0) to week 8.
Secondary outcome [14] 448230 0
Client engagement (group)
Timepoint [14] 448230 0
From baseline (week 0) to week 8. Measured weekly.
Secondary outcome [15] 448231 0
Unwanted negative side effects
Timepoint [15] 448231 0
Post-treatment (week 8).

Eligibility
Key inclusion criteria
Key Inclusion Criteria
1. Aged 18 years or over
2. Australian resident
3. Proficient in English language
4. Have access to the internet
5. Have access to a smartphone with a supported operating system (Apple: iOS 13 released 1999 or newer; Android: 7.0 released 2016 or newer).
6. Have elevated scores on the General Anxiety Disorder 7-item Scale (total of 10 or above)
7. Meet criteria for generalised anxiety disorder, social anxiety disorder, panic disorder and/or illness anxiety disorder
8. Willing to provide demographic information (name, age, gender, address, phone number), details of an emergency contact and their GP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under the age of 18 years
2. General Anxiety Disorder 7-item Scale score of 9 or below
3. Self-reported diagnosis of schizophrenia, bipolar disorder, or current psychotic symptoms
4. Current frequent suicidal ideation (score of 3 on Item 9 of the PHQ-9) or acutely suicidal (current suicide plan or intent)
5. Self-reported substance use issues as measured by the CAGE-AID screener (total score of 2 or above)
6. Very severe depression (PHQ-9 scores of 24 and above)
7. Commencement of a new mental health medication or change in dose of existing medication in the two months prior to application
8. Currently engaged in Cognitive behavioural therapy for anxiety


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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intention-to-treat linear mixed models will be used to analyse the pre to post changes in symptoms (e.g., anxiety) and other outcomes (e..g, depression severity). A random intercept for participant will be included, along with fixed effects of time, with separate mixed models conducted for each outcome variable. Effect sizes (Hedges' g, with 95% confidence intervals) for the pre to post-treatment change in outcomes will be calculated. To compare the difference between program completers (all 8 sessions completed) versus non-completers (less than 8 sessions attended), we will conduct independent samples t tests, and chi square analyses on key variables (e.g., age, symptom severity). Other variables (e.g., treatment satisfaction) will be reported using descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319029 0
Government body
Name [1] 319029 0
NHMRC
Country [1] 319029 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 321494 0
None
Name [1] 321494 0
Address [1] 321494 0
Country [1] 321494 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317638 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 317638 0
Ethics committee country [1] 317638 0
Australia
Date submitted for ethics approval [1] 317638 0
19/05/2025
Approval date [1] 317638 0
Ethics approval number [1] 317638 0

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

Contacts
Principal investigator
Name 141650 0
Prof Jill Newby
Address 141650 0
Black Dog Institute, Hospital Road Randwick, NSW 2031
Country 141650 0
Australia
Phone 141650 0
+61 29065 9108
Fax 141650 0
Email 141650 0
[email protected]
Contact person for public queries
Name 141651 0
Jill Newby
Address 141651 0
Black Dog Institute, Hospital Road Randwick, NSW 2031
Country 141651 0
Australia
Phone 141651 0
+61 29065 9108
Fax 141651 0
Email 141651 0
[email protected]
Contact person for scientific queries
Name 141652 0
Prof Jill Newby
Address 141652 0
Black Dog Institute, Hospital Road Randwick, NSW 2031
Country 141652 0
Australia
Phone 141652 0
+61 29065 9108
Fax 141652 0
Email 141652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.