Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000337178
Ethics application status
Approved
Date submitted
25/02/2019
Date registered
5/03/2019
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Date results information initially provided
5/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transdiagnostic Cognitive Behavioral Therapy for the Treatment of Emotional Disorders
Scientific title
Transdiagnostic Cognitive Behavioral Therapy for the Treatment of Emotional Disorders
Secondary ID [1] 297520 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311724 0
Anxiety Disorders 311725 0
Condition category
Condition code
Mental Health 310347 310347 0 0
Depression
Mental Health 310348 310348 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being examined is Transdiagnostic Cognitive Behavioral Therapy, based on
"Group Cognitive Behavioral Therapy for Anxiety: A transdiagnostic treatment manual" by Norton (2012; Guilford Press). The treatment is Cognitive Behavioral Therapy, including psychoeducation, cognitive restructuring, and emotional engagements, and will be administered by provisional psychologists (DPsych) under supervision of a Registered Psychologist. Both Group and Individual treatment options are available at the discretion of the Principal Investigator based on patient flow (group in high demand periods, individual during low demand periods), and both will involve 12 weekly sessions (2 hours per session for group, 1 hour per session for individual). All treatment will take place at the Monash FEAR Clinic (Notting Hill, VIC). Treatment will also involve Homework (between-session emotional engagements) of approximately 10-15 minutes per day which will be assessed at each sessions using a Homework Compliance Checklist. Homework emotional engagements will involve practicing confronting and tolerating situations that provoke your negative emotional states.
Intervention code [1] 313757 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319222 0
Anxiety Disorder Interview Schedule for DSM-5 Clinician Severity Rating
Timepoint [1] 319222 0
Immediately Post Treatment (week 12)
Secondary outcome [1] 367362 0
Clinical Global Impressions - Severity
Timepoint [1] 367362 0
Immediately Post-Treatment (week 12)

Eligibility
Key inclusion criteria
DSM-5 Principal Depressive or Anxiety Disorder Diagnosis
18 years or older
Adequately proficiency in English to participate in treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or other neurocognitive disorders that could impair their ability to provide informed consent or actively engage in treatment
Serious suicidality, substance use requiring detoxification, or any other condition that warranted immediate intervention

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/08/2016
Date of last participant enrolment
Anticipated
Actual
28/08/2017
Date of last data collection
Anticipated
Actual
15/05/2018
Sample size
Target
16
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25807 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 302078 0
Government body
Name [1] 302078 0
Australian Government Research Training Program (RTP) Scholarship
Country [1] 302078 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd,
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 301896 0
None
Name [1] 301896 0
Address [1] 301896 0
Country [1] 301896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302759 0
Monash University Human Subjects Research Committee
Ethics committee address [1] 302759 0
Wellington Rd,
Clayton VIC 3800
Ethics committee country [1] 302759 0
Australia
Date submitted for ethics approval [1] 302759 0
16/10/2015
Approval date [1] 302759 0
21/12/2015
Ethics approval number [1] 302759 0
CF15/3820 - 2015001672

Summary
Brief summary
The purpose of the proposed research is to develop an ongoing empirical evaluation of the effectiveness of transdiagnostic cognitive-behavioural treatments (tCBT) for emotional disorders.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91298 0
Prof Peter Norton
Address 91298 0
18 Innovation Walk
Monash University
Clayton, VIC 3800
Country 91298 0
Australia
Phone 91298 0
+61 (3) 9905 1709
Fax 91298 0
Email 91298 0
[email protected]
Contact person for public queries
Name 91299 0
Ms Kelly Harris
Address 91299 0
18 Innovation Walk
Monash University
Clayton, VIC 3800
Country 91299 0
Australia
Phone 91299 0
+61 (3) 9902 4480
Fax 91299 0
Email 91299 0
[email protected]
Contact person for scientific queries
Name 91300 0
Prof Peter Norton
Address 91300 0
18 Innovation Walk
Monash University
Clayton, VIC 3800
Country 91300 0
Australia
Phone 91300 0
+61 (3) 9905 1709
Fax 91300 0
Email 91300 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
Confidential patient information


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1451Ethical approval    377060-(Uploaded-25-02-2019-10-23-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Results suggested significant improvement in princ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTransdiagnostic cognitive behavioral therapy for the treatment of emotional disorders: A preliminary open trial.2019https://dx.doi.org/10.1016/j.jbtep.2019.101487
N.B. These documents automatically identified may not have been verified by the study sponsor.