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Trial registered on ANZCTR


Registration number
ACTRN12611000527965
Ethics application status
Approved
Date submitted
13/05/2011
Date registered
23/05/2011
Date last updated
7/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Older Adult Anxiety and Depression Treatment Outcome Study
Scientific title
A randomised controlled trial of two psychosocial group treatment programs for comorbid anxiety and depression in older adults
Secondary ID [1] 262171 0
Nil
Universal Trial Number (UTN)
U1111-1121-3742
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 265855 0
Depression 265856 0
Condition category
Condition code
Mental Health 266011 266011 0 0
Depression
Mental Health 266012 266012 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychosocial Intervention 1. The group program runs for 11 * 2 hour sessions run over a 12 week period, in groups of 6-8 participants by an intern psychologist.
Intervention code [1] 264614 0
Behaviour
Intervention code [2] 264615 0
Treatment: Other
Comparator / control treatment
Psychosocial Intervention 2. The group program runs for 11 * 2 hour sessions run over a 12 week period, in groups of 6-8 participants by an intern psychologist.
Control group
Active

Outcomes
Primary outcome [1] 266754 0
Changes in diagnostic status and severity according to the Anxiety Disorders Interview Schedule
Timepoint [1] 266754 0
Pre compared to post and 6 month follow up
Primary outcome [2] 266755 0
Changes in cognitive fucntioning over time according to performance on the Addenbrooke Cognitive Examination Revised
Timepoint [2] 266755 0
Pre to post and 6 month follow up
Secondary outcome [1] 276311 0
Changes on self-report measures:
Geriatric Anxiety Inventory
Geriatric Depression Scale
World Health Organisation Quality of Life Measure Brief
Patient Health Questionnaire - 4
Kessler 10
Timepoint [1] 276311 0
Pre to post and 6 month follow up

Eligibility
Key inclusion criteria
Older adults
Comorbid symptoms of anxiety and depression
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Delirium
Moderate to Severe dementia
self harm
suicidal intent
psychosis
alcohol/drug abuse
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)
allocation involved contacting the holder of the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Suitable participants were randomly allocated to one of the two treatment interventions. Randomisation was based on a computer generated randomisation sequence.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
18/07/2011
Date of last participant enrolment
Anticipated
Actual
20/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 265078 0
Government body
Name [1] 265078 0
National Health and Medical Research Council
Country [1] 265078 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country
Australia
Secondary sponsor category [1] 264168 0
None
Name [1] 264168 0
Address [1] 264168 0
Country [1] 264168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267058 0
Human Ethics Committee Macquarie Univeristy
Ethics committee address [1] 267058 0
Ethics committee country [1] 267058 0
Australia
Date submitted for ethics approval [1] 267058 0
12/04/2011
Approval date [1] 267058 0
09/06/2011
Ethics approval number [1] 267058 0

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

Contacts
Principal investigator
Name 32608 0
Dr Viviana Wuthrich
Address 32608 0
Centre for Emotional Health,
Department of Psychology,
Macquarie University,
Sydney, NSW, Australia 2109
Country 32608 0
Australia
Phone 32608 0
+61 2 9850 4866
Fax 32608 0
Email 32608 0
[email protected]
Contact person for public queries
Name 15855 0
Jacqueline Frei
Address 15855 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW, 2109
Country 15855 0
Australia
Phone 15855 0
+ 61 2 9850 8034
Fax 15855 0
Email 15855 0
[email protected]
Contact person for scientific queries
Name 6783 0
Viviana Wuthrich
Address 6783 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW, 2109
Country 6783 0
Australia
Phone 6783 0
+ 61 2 9850 4866
Fax 6783 0
Email 6783 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
SourceTitleYear of PublicationDOI
EmbaseRandomized controlled trial of group cognitive behavioral therapy compared to a discussion group for co-morbid anxiety and depression in older adults.2016https://dx.doi.org/10.1017/S0033291715002251
N.B. These documents automatically identified may not have been verified by the study sponsor.