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
14/09/2005
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.
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
Recruiting
Date of first participant enrolment
Anticipated
3/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

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

Contacts
Principal investigator
Name 35648 0
Address 35648 0
Country 35648 0
Phone 35648 0
Fax 35648 0
Email 35648 0
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 38644929
Fax 9546 0
+61 7 38644755
Email 9546 0
e.strodl@qut.edu.au
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
e.strodl@qut.edu.au

No information has been provided regarding IPD availability


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.