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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
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Trial registered on ANZCTR
Registration number
ACTRN12625000637448
Ethics application status
Approved
Date submitted
20/05/2025
Date registered
17/06/2025
Date last updated
6/09/2025
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
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Scientific title
Pilot Trial of the Effect of a Transdiagnostic Blended Care Group for Anxiety in Adults
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Secondary ID [1]
314488
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder
337527
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Social anxiety disorder
337528
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Illness anxiety disorder
337529
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Panic Disorder
337530
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Condition category
Condition code
Mental Health
333895
333895
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0
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Anxiety
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Mental Health
333896
333896
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0
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Depression
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Mental Health
333995
333995
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
331111
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Behaviour
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Changes in generalised anxiety symptoms
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Assessment method [1]
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Scores on the 7-item Generalised Anxiety Disorder Scale (GAD-7).
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Timepoint [1]
341538
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8). Primary time-point is post-treatment.
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Secondary outcome [1]
447877
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Changes in depression symptoms
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Assessment method [1]
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Scores on the Patient Health Questionnaire-9 (PHQ-9)
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Timepoint [1]
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
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Secondary outcome [2]
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Changes in social anxiety symptoms.
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Assessment method [2]
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The Social Phobia Inventory – Short Form (Mini-SPIN)
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Timepoint [2]
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
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Secondary outcome [3]
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Changes in panic symptoms
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Assessment method [3]
447879
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Scores on the Panic Disorder Screener (PADIS).
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Timepoint [3]
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
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Secondary outcome [4]
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Changes in illness anxiety symptoms
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Assessment method [4]
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Scores on the Whiteley Index-6 (WI-6)
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Timepoint [4]
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
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Secondary outcome [5]
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Changes in perceived self-efficacy
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Assessment method [5]
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Scores on the General Self-Efficacy Scale (GSES).
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Timepoint [5]
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
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Secondary outcome [6]
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Changes in perceived functioning
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Assessment method [6]
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Scores on the Work and Social Functioning Scale (WSAS)
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Timepoint [6]
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Baseline (week 0), mid-treatment (week 4), post-treatment (week 8).
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Secondary outcome [7]
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Changes in depression symptoms
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Assessment method [7]
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Scores on the depression subscale of the 21-item Depression, Anxiety, Stress Scales (DASS-21)
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Timepoint [7]
447913
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Baseline (week 0), each week during treatment phase (week 0 to week 8).
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Secondary outcome [8]
447914
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Changes in anxiety symptoms
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Assessment method [8]
447914
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Scores on the anxiety subscale of the 21-item Depression, Anxiety, Stress Scales (DASS-21)
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Timepoint [8]
447914
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Baseline (week 0), each week during treatment phase (week 0 to week 8).
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Secondary outcome [9]
447915
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Changes in stress symptoms
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Assessment method [9]
447915
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Scores on the stress subscale of the 21-item Depression, Anxiety, Stress Scales (DASS-21)
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Timepoint [9]
447915
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Baseline (week 0), each week during treatment phase (week 0 to week 8).
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Secondary outcome [10]
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Change in satisfaction with group program
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Assessment method [10]
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Scores on the Group Session Rating Scale (GSRS) taken each week
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Timepoint [10]
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Each week during treatment phase (week 0 to week 8).
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Secondary outcome [11]
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Treatment acceptability
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Assessment method [11]
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Bespoke survey on overall experience and acceptability of the intervention.
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Timepoint [11]
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Post-treatment (week 8)
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Secondary outcome [12]
447918
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Treatment satisfaction
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Assessment method [12]
447918
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Scores on the Treatment Satisfaction Questionnaire (TSQ)
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Timepoint [12]
447918
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Post-treatment (week 8)
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Secondary outcome [13]
447919
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Client engagement (app usage)
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Assessment method [13]
447919
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App usage metrics as a composite secondary outcome (e.g., time spent using app, number and type of modules completed, number of days using app, number of repeat uses of app)
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Timepoint [13]
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Continuously from baseline (week 0) to week 8.
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Secondary outcome [14]
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Client engagement (group)
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Assessment method [14]
448230
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Number of group sessions attended, determined by session attendance checklists.
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Timepoint [14]
448230
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From baseline (week 0) to week 8. Measured weekly.
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Secondary outcome [15]
448231
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Unwanted negative side effects
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Assessment method [15]
448231
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Bespoke measure of unwanted side effects of the intervention.
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Timepoint [15]
448231
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Post-treatment (week 8).
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
319029
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Government body
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Name [1]
319029
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NHMRC
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Address [1]
319029
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Country [1]
319029
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Australia
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Primary sponsor type
University
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Name
UNSW Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321494
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Address [1]
321494
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Country [1]
321494
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317638
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
317638
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
317638
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Australia
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Date submitted for ethics approval [1]
317638
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19/05/2025
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Approval date [1]
317638
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01/08/2025
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Ethics approval number [1]
317638
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Summary
Brief summary
This pilot trial will explore the acceptability, feasibility and outcomes of a blended care group program which combines 8 group therapy sessions with a smartphone app, called MyNewWay. The purpose is to evaluate the short-term outcomes of this new blended care intervention for adults with anxiety disorders.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jill Newby
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Address
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Black Dog Institute, Hospital Road Randwick, NSW 2031
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Country
141650
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Australia
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Phone
141650
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+61 29065 9108
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Fax
141650
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Email
141650
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[email protected]
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Contact person for public queries
Name
141651
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Jill Newby
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Address
141651
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Black Dog Institute, Hospital Road Randwick, NSW 2031
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Country
141651
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Australia
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Phone
141651
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+61 29065 9108
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Fax
141651
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Email
141651
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[email protected]
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Contact person for scientific queries
Name
141652
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Prof Jill Newby
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Address
141652
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Black Dog Institute, Hospital Road Randwick, NSW 2031
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Country
141652
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Australia
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Phone
141652
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+61 29065 9108
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Fax
141652
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Email
141652
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[email protected]
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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.
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