Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000615684
Ethics application status
Approved
Date submitted
22/05/2023
Date registered
5/06/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
5/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A One Day Expedited Treatment for Adults with Anxiety Disorders
Scientific title
A One Day Expedited Treatment for Anxiety Disorders: A Feasibility Study
Secondary ID [1] 309713 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety disorders 330102 0
Condition category
Condition code
Mental Health 326988 326988 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Due to the high rates of comorbidity between the anxiety disorders, the intervention will be transdiagnostic, meaning it will target multiple anxiety disorders simultaneously. Participants will receive 6 hours of treatment in a single day (10am-6pm with a 1 hour lunch break, and two 30 minute breaks (morning tea and afternoon tea; not provided). The treatment will be manualised/standardised and include standard cognitive and behavioural interventions that have been found to be efficacious in other studies (Norton, 2008; Titov et al., 2010; Norton et al., 2012). The treatment will be delivered face-to-face by Master of Clinical Psychology students in the purpose-built clinical psychology facilities at the University of Technology Sydney. All sessions will be audio-recorded. A minimum of 10% of all treatment sessions will be reviewed to ensure fidelity to the treatment manual.

Participants will receive psychoeducation on the nature of anxiety disorders, the cognitive-behavioural model, and cognitive behavioural therapy. Using the information obtained during the diagnostic interview, the therapist will assist participants in identifying unhelpful thoughts/beliefs and unhelpful behaviours and assist the client in putting these in to the CBT model. Unhelpful beliefs will be challenged via two cognitive techniques – examining the evidence for and against the thought and behavioural experiments, both are standard and commonly used cognitive interventions delivered as part of CBT. Examining the evidence involves looking at each thought/belief and looking at the evidence to support and contradict it. The goal of this intervention is to help the client to see their thought/belief in a more realistic way. Behavioural experiments help the client to test out their thinking by making predictions about what they think will happen when they do something they fear (i.e., talk to a stranger for someone with social anxiety disorder) and then do the task and observe the outcome. This technique helps client to see that they are generally over-estimating the likelihood of bad things happening, and even if something they predict does happen (i.e., the person is not nice to them) that they can cope with this. Worksheets will be used to assist in the delivery of this intervention. Relapse prevention involves summarising the interventions and setting up a plan to prevent any future relapse. The therapist and participant will also set up homework that the participant can continue to work on during the follow up period.
Intervention code [1] 326152 0
Treatment: Other
Comparator / control treatment
This is an open trial where all participants are provided the treatment. This is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334831 0
Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [1] 334831 0
Pre-treatment
Post-treatment (primary end-point) (within one-week post-treatment)
1-month follow up
3-month follow up
Primary outcome [2] 334832 0
Clinical Global Impression (CGI) scale (measuring overall severity of anxiety symptoms)
Timepoint [2] 334832 0
Pre-treatment
Post-treatment (primary end-point) (within one-week post-treatment)
1-month follow up
3-month follow up
Primary outcome [3] 334833 0
Client Satisfaction Questionnaire (CSQ)
Timepoint [3] 334833 0
Post-treatment (within one-week post-treatment)
Secondary outcome [1] 422207 0
Social Anxiety Disorder Dimensional Scale (SAD-D)
Timepoint [1] 422207 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [2] 422208 0
Panic Disorder Dimensional Scale (PD-D)
Timepoint [2] 422208 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [3] 422209 0
Agoraphobia Dimensional Scale (AG-D)
Timepoint [3] 422209 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [4] 422210 0
Generalised Anxiety Disorder Dimensional Scale (GAD-D)
Timepoint [4] 422210 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [5] 422211 0
Specific Phobia Dimensional Scale (SP-D)
Timepoint [5] 422211 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [6] 422212 0
Separation Anxiety Disorder Dimensional Scale
Timepoint [6] 422212 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [7] 422213 0
Patient Health Questionnaire – 9 item (PHQ-9)
Timepoint [7] 422213 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up
Secondary outcome [8] 422214 0
Sheehan Disability Scale (SDS)
Timepoint [8] 422214 0
Pre-treatment
Post-treatment (within one-week post-treatment)
1-month follow up
3-month follow up

Eligibility
Key inclusion criteria
(1) Australian resident;
(2) 18-years-of-age or above;
(3) Able to read and write English;
(4) Meet criteria for an anxiety disorder as their primary mental health condition on the Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive and other Neuropsychiatric Disorders (DIAMOND);
(5) Medication free or on a stable dose of psychotropic medication for at least 8 weeks, and;
(6) Not currently receiving regular psychological services for their anxiety disorder (i.e., those seeing their clinician once a week or more will be excluded).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Severe depressive symptoms as assessed by a score of 20 or above on the PHQ-9;
(2) Suicide risk as assessed by a score of ‘2’ (more than half the days) or higher on item 9 of the PHQ-9 on the screening questions or via clinician judgement during the diagnostic interview using the C-SSRS;
(3) Daily alcohol use or daily illicit drug use;
(4) The presence of a schizophrenia spectrum disorder as assessed by the DIAMOND;
(5) Significant cognitive/intellectual impairment as assessed during the diagnostic interview;
(6) A medical condition that may interfere with treatment as indicated on the demographic questionnaire.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2023
Actual
5/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313907 0
University
Name [1] 313907 0
University of Technology Sydney
Country [1] 313907 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Graduate School of Health
Po Box 123
Broadway
NSW, 2007
Country
Australia
Secondary sponsor category [1] 315761 0
None
Name [1] 315761 0
Address [1] 315761 0
Country [1] 315761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313053 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 313053 0
Ethics committee country [1] 313053 0
Australia
Date submitted for ethics approval [1] 313053 0
13/03/2023
Approval date [1] 313053 0
23/06/2023
Ethics approval number [1] 313053 0
UTS HREC REF NO. ETH23-8102.

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

Contacts
Principal investigator
Name 126826 0
A/Prof Bethany Wootton
Address 126826 0
Discipline of Clinical Psychology
University of Technology Sydney
Po Box 123
Broadway
NSW, 2007
Country 126826 0
Australia
Phone 126826 0
+61 2 9514 3942
Fax 126826 0
Email 126826 0
[email protected]
Contact person for public queries
Name 126827 0
Bethany Wootton
Address 126827 0
Discipline of Clinical Psychology
University of Technology Sydney
Po Box 123
Broadway
NSW, 2007
Country 126827 0
Australia
Phone 126827 0
+61 2 9514 3942
Fax 126827 0
Email 126827 0
[email protected]
Contact person for scientific queries
Name 126828 0
Bethany Wootton
Address 126828 0
Discipline of Clinical Psychology
University of Technology Sydney
Po Box 123
Broadway
NSW, 2007
Country 126828 0
Australia
Phone 126828 0
+61 2 9514 3942
Fax 126828 0
Email 126828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been approved by the HREC


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.