Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000486820
Ethics application status
Approved
Date submitted
12/02/2021
Date registered
26/04/2021
Date last updated
7/03/2023
Date data sharing statement initially provided
26/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Trial of the Effect of Transdiagnostic Cognitive Behavioural Therapy on Clinical Severity Ratings for Adults with Emotional Disorders
Scientific title
An Open Trial of the Effect of Transdiagnostic Cognitive Behavioural Therapy on Clinical Severity Ratings for Adults with Emotional Disorders
Secondary ID [1] 303433 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders, 320735 0
Depressive Disorders 320736 0
Obsessive-Compulsive and Related Disorders 320737 0
Trauma and Stress-Related Disorders 320738 0
Condition category
Condition code
Mental Health 318575 318575 0 0
Anxiety
Mental Health 318576 318576 0 0
Depression
Mental Health 319118 319118 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment protocol to follow Transdiagnostic Cognitive Behavioural Therapy (Norton, P. J. 2012. Group cognitive behavioral therapy for anxiety: A transdiagnostic treatment manual. Guilford Press; incorporating modifications for depressive diagnoses from Harris, K. R. & Norton, P. J. (2019). Transdiagnostic cognitive behavioral therapy for the treatment of emotional disorders: An open trial. Journal of Behavior Therapy and Experimental Psychiatry, 65, 101487. doi: 10.1016/j.btep.2019.101487 and Harris, K. R. & Norton, P. J. (2018). Transdiagnostic cognitive behavioral therapy for the treatment of emotional disorders: A group case study. Clinical Case Studies, 17, 387-405. doi: 10.1177/1534650118793938). 10 weekly one-hour sessions. Therapeutic elements include psychoeductaion (session 1), cognitive restructuring (sessions 2 and 3), Emotional Engagements (exposure/behavioural activation; sessions 4-9), and termination and relapse prevention (session 10). Between-session activities (i.e., "homework") will be assigned each session and will involve continued practice of within-session activities including cognitive restructuring practice or emotional engagements. Homework duration each week will vary by the specific task, but is not expected to require more than one hour total per week. Adherence to be monitored via session attendance and between-session activity (homework) completion ratings. Delivered individually, in person or video-conference due to pandemic restrictions. Delivered by Psychology Board of Australia (PsyBA) registered psychologists or PsyBA provisionally-registered psychologists under the supervision of a PsyBA registered clinical psychologist with supervisor endorsement.
Intervention code [1] 319737 0
Treatment: Other
Intervention code [2] 320380 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326534 0
Clinician severity ratings (CSR; 0 Absent to 8 Extremely Severe) of the principal diagnosis
Timepoint [1] 326534 0
week 11 (immediately post-treatment)
Secondary outcome [1] 391797 0
Depression Anxiety and Stress Scales (DASS-21) Anxiety Scale
Timepoint [1] 391797 0
Change modelled session-by-session from week 1 to week 12.
Secondary outcome [2] 391798 0
World Health Organisation Quality of Life - brief version (WHO-QUL-bref)
Timepoint [2] 391798 0
Week 11 (immediately post-treatment)
Secondary outcome [3] 393431 0
Depression Anxiety and Stress Scales (DASS-21) Depression Scale
Timepoint [3] 393431 0
Change modelled session-by-session from week 1 to week 12.

Eligibility
Key inclusion criteria
Adult (18+); DSM-5 principal diagnosis of an anxiety disorder, depressive disorder, obsessive-compulsive disorrder, or post traumatic stress disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to read and communicate in English sufficiently to understand and participate in
assessment and treatment with English-speaking therapists
2) Evidence of dementia or other neurocognitive condition that might interfere with informed consent, or understanding and participating in treatment
3) Evidence of serious suicidality, current alcohol or illicit substance dependence, or any other condition of sufficient severity that requires immediate clinical prioritization.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed effect regression modelling of change in primary and secondary outcomes over time.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33154 0
3123 - Hawthorn East

Funding & Sponsors
Funding source category [1] 307854 0
Charities/Societies/Foundations
Name [1] 307854 0
Cairnmillar Institute Trust
Country [1] 307854 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cairnmillar Institute
Address
391-393 Tooronga Rd, Hawthorn East, Victoria 3123
Country
Australia
Secondary sponsor category [1] 308565 0
None
Name [1] 308565 0
Address [1] 308565 0
Country [1] 308565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307858 0
Cairnmillar Institute Human Ethics Review Committee
Ethics committee address [1] 307858 0
Ethics committee country [1] 307858 0
Australia
Date submitted for ethics approval [1] 307858 0
01/10/2020
Approval date [1] 307858 0
23/12/2020
Ethics approval number [1] 307858 0
2020100801

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

Contacts
Principal investigator
Name 108726 0
Prof Peter J Norton
Address 108726 0
The Cairnmillar Institute Anxiety and Depression Clinic
391-393 Tooronga Rd., Hawthorn East, VIC 3123
Country 108726 0
Australia
Phone 108726 0
+61 3 9813 3400
Fax 108726 0
Email 108726 0
[email protected]
Contact person for public queries
Name 108727 0
Peter J Norton
Address 108727 0
The Cairnmillar Institute Anxiety and Depression Clinic
391-393 Tooronga Rd., Hawthorn East, VIC 3123
Country 108727 0
Australia
Phone 108727 0
+61 3 9813 3400
Fax 108727 0
Email 108727 0
[email protected]
Contact person for scientific queries
Name 108728 0
Peter J Norton
Address 108728 0
The Cairnmillar Institute Anxiety and Depression Clinic
391-393 Tooronga Rd., Hawthorn East, VIC 3123
Country 108728 0
Australia
Phone 108728 0
+61 3 9813 3400
Fax 108728 0
Email 108728 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


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.