Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000528954
Ethics application status
Approved
Date submitted
13/05/2011
Date registered
23/05/2011
Date last updated
23/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A psychosocial group program for the treatment of anxiety and depression in older adults (aged 60 years and older)
Scientific title
A randomised controlled trial of group cognitive behaviour therapy for older adults with comorbid anxiety and depression compared to wait list.
Secondary ID [1] 262170 0
Nil
Universal Trial Number (UTN)
U1111-1121-3720
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 265853 0
Depression 265854 0
Condition category
Condition code
Mental Health 266009 266009 0 0
Anxiety
Mental Health 266010 266010 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group cognitive behaviour therapy focused on psychoeducation, cognitive restructuring, graded exposure, behavioural activation, problem solving, assertive communication, and sleep hygiene. The group problem involved 12 X 2 hour weekly sessions and was led by an intern psychologist.
Intervention code [1] 264579 0
Treatment: Other
Intervention code [2] 266625 0
Behaviour
Comparator / control treatment
Wait list condition of 12 weeks duration. At the end of the 12 week wait, participants completed post-assessments and then were offered participation in the next treatment group.
Control group
Active

Outcomes
Primary outcome [1] 266753 0
Changes in diagnostic status and severity according to the Anxiety Disorders Interview Schedule, semi-structured clinical interview
Timepoint [1] 266753 0
Pre, to post and 3 month follow up
Secondary outcome [1] 276310 0
Changes on self-report measures:
Geriatric Depression Inventory
Geriatric Anxiety Inventory
Centre for Epidemiological Studies- Depression Scale
Depression, Anxiety and Stress Scale
Short Form -12
Timepoint [1] 276310 0
Pre to post treatment and at 3 month follow up

Eligibility
Key inclusion criteria
Older adult
Comorbid anxiety and depression as determined by clinical interview with the Anxiety Disorders Interview Schedule
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moderate to severe dementia
psychosis
alcohol/drug abuse
self-harm
suicidal intentions
Delirium
Bipolar disorder

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)
Participants completed diagnostic interview. Suitable participants were then randomly allocated to treatment or waitlist condition based on apriori randomised allocation schedule. Allocation concealment involved contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator was used to specify randomisation sequence for the full trial apriori
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265077 0
University
Name [1] 265077 0
Macquarie University
Country [1] 265077 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Sydney, NSW 2109
Country
Australia
Secondary sponsor category [1] 264167 0
None
Name [1] 264167 0
Address [1] 264167 0
Country [1] 264167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267057 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 267057 0
Macquarie University
Sydney, NSW 2109
Ethics committee country [1] 267057 0
Australia
Date submitted for ethics approval [1] 267057 0
Approval date [1] 267057 0
01/08/2008
Ethics approval number [1] 267057 0

Summary
Brief summary
The purpose of thsi study was to test the effectiveness of a group cognitive behaviour therapy program for older adults with comorbid anxiety and depression compared to a wait list condition. It was hypothesised that the group program would produce clinically significant and lasting improvements in anxiety and depression symptoms as comapred to the wait list condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32607 0
Address 32607 0
Country 32607 0
Phone 32607 0
Fax 32607 0
Email 32607 0
Contact person for public queries
Name 15854 0
Viviana Wuthrich
Address 15854 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 15854 0
Australia
Phone 15854 0
+61 2 9850 4866
Fax 15854 0
Email 15854 0
[email protected]
Contact person for scientific queries
Name 6782 0
Viviana Wuthrich
Address 6782 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 6782 0
Australia
Phone 6782 0
+ 61 2 9850 4866
Fax 6782 0
Email 6782 0
[email protected]

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.