Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000392662
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
14/09/2005
Date last updated
22/06/2025
Date data sharing statement initially provided
22/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative Study on Group Therapy for Generalised Anxiety Disorder
Scientific title
A randomised study to compare the effectiveness of three forms of group therapy for the treatment of generalised anxiety disorder. Outcomes measured are changes in symptoms and psychological processes commonly associated with GAD.
Secondary ID [1] 314712 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 496 0
Condition category
Condition code
Mental Health 576 576 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly assigned to one of three forms of group psychotherapy: cognitive behaviour therapy, emotion focused therapy, or psychodynamic therapy. Each group therapy has a dosage of a 2 hour session each week for 9 weeks.
Intervention code [1] 357 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 662 0
Self report measure: State-Trait Anxiety Inventory Depression Anxiety Stress Scale (DASS)
Timepoint [1] 662 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [2] 663 0
Self report measure: Penn State Worry Scale
Timepoint [2] 663 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [3] 664 0
Self report measure:Anxiety Sensitivity Index
Timepoint [3] 664 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [4] 665 0
Self report measure:Anxious Thoughts Questionnaire
Timepoint [4] 665 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [5] 666 0
Self report measure: Meta-Cognitions Questionnaire
Timepoint [5] 666 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [6] 667 0
Self report measure: Toronto Alexithymia Scale (TAS-20)
Timepoint [6] 667 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [7] 668 0
Self report measure: Interpersonal sensitivity index
Timepoint [7] 668 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Primary outcome [8] 669 0
Self report measure: Working Alliance
Timepoint [8] 669 0
Measured at pre-therapy, post-therapy and 6 month follow-up
Secondary outcome [1] 1376 0
Heart rate variabilty
Timepoint [1] 1376 0
Measured at pre-therapy and post-therapy.

Eligibility
Key inclusion criteria
Criteria DSM IV diagnosis of Generalised Anxiety Disorder.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor English language abilitiesCognitive deficits (intellectual disability, dementia, delirium, significant head injury)Psychotic illnessDisclosure of risk of harm to self or others.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequence generated by roll of dice
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2005
Actual
3/01/2005
Date of last participant enrolment
Anticipated
Actual
10/10/2008
Date of last data collection
Anticipated
Actual
30/08/2009
Sample size
Target
60
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 626 0
University
Name [1] 626 0
QUT Internal Grant
Country [1] 626 0
Australia
Primary sponsor type
Individual
Name
Esben Strodl
Address
Country
Secondary sponsor category [1] 511 0
Individual
Name [1] 511 0
Robert Schweitzer
Address [1] 511 0
Country [1] 511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317843 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 317843 0
Ethics committee country [1] 317843 0
Australia
Date submitted for ethics approval [1] 317843 0
31/08/2004
Approval date [1] 317843 0
01/11/2004
Ethics approval number [1] 317843 0

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

Contacts
Principal investigator
Name 35648 0
A/Prof Esben Strodl
Address 35648 0
School of Psychology and Counselling Queensland University of Technology Victoria Park Rd Kelvin Grove 4059 Queensland
Country 35648 0
Australia
Phone 35648 0
+61 7 3138 8416
Fax 35648 0
Email 35648 0
[email protected]
Contact person for public queries
Name 9546 0
Dr Esben Strodl
Address 9546 0
School of Psychology and Counselling Queensland University of Technology Carsdeline Campus Cnr Beams and Dorville Rds Carseline QLD 4034
Country 9546 0
Australia
Phone 9546 0
+61 7 31388416
Fax 9546 0
+61 7 38644755
Email 9546 0
[email protected]
Contact person for scientific queries
Name 474 0
Dr Esben Strodl
Address 474 0
School of Psychology and Counselling Queensland University of Technology Carsdeline Campus Cnr Beams and Dorville Rds Carseline QLD 4034
Country 474 0
Australia
Phone 474 0
+61 7 38644929
Fax 474 0
+61 7 38644755
Email 474 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.