Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000364875
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
29/03/2012
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving anxiety assessment and management in people with cognitive impairment and dementia: Validation of an informant measure and pilot testing of a multi-component behavioural intervention.
Scientific title
In cognitively impaired patients, is a 12-week multi-component behavioural intervention effective in the treatment of anxiety.
Secondary ID [1] 263048 0
Nil
Universal Trial Number (UTN)
U1111-1124-5722
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety in cognitively impaired people 270781 0
Condition category
Condition code
Mental Health 270969 270969 0 0
Anxiety
Neurological 286331 286331 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study of a 12 week multi-component behavioural intervention for people with dementia with clinically significant anxiety. The behavioural intervention will engage both the person with dementia and an unpaid caregiver. Components will include psychoeducation, anxiety monitoring, relaxation training, activity scheduling, and a sleep intervention. The sleep intervention will provide participants with techniques to improve night-time sleep. The focus will be on helping family members to better manage anxiety and associated behaviours. The program will be conducted by trained personnel. The sessions will be weekly and each session will last approximately 40 minutes.
Intervention code [1] 1577 0
Behaviour
Intervention code [2] 284529 0
Treatment: Other
Comparator / control treatment
The comparator for this study will involve 12 weekly sessions lasting approximately 40 minutes each. The sessions will be conducted by trained personnal and will involve discussion of neutral photographs. This program has been designed to control for therapist time and attention without providing any specific anti-anxiety effect.
Control group
Active

Outcomes
Primary outcome [1] 2928 0
Feasibility of study will be assessed through compliance with the protocol.
Timepoint [1] 2928 0
12 weeks
Primary outcome [2] 279630 0
% of patients with GAI anxiety score <10
Timepoint [2] 279630 0
12 Weeks
Secondary outcome [1] 294095 0
% of patients with improved IQAD scores
Timepoint [1] 294095 0
12 weeks
Secondary outcome [2] 294104 0
% of patients with HAM-A scores <17
Timepoint [2] 294104 0
12 weeks
Secondary outcome [3] 294105 0
% of patients showing improved QOL-AD scores
Timepoint [3] 294105 0
12 weeks

Eligibility
Key inclusion criteria
patients of RBWH memory clinic with cognitive impairment and significant anxiety symptoms
informant who has regular contact with participant
able to understand english
at least 60 years of age
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients without cognitive impairment
patients without significant anxiety symptoms
patients without suitable informant
patients non-fluent in english
under the age of 60

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)
Opaque envelopes containing the group allocation will be used to allocate participants to one of the two groups. An independent person will prepare the envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent person will obtain a randomization code from the following website: http://www.graphpad.com/quickcalcs/randomize1.cfm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pilot study to determine protocol feasibility
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 269859 0
Government body
Name [1] 269859 0
Dementia Collaborative Research Centre - Carers and Consumers
Country [1] 269859 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Medicine
K Floor, Mental Health Centre
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 2034 0
None
Name [1] 2034 0
Address [1] 2034 0
Country [1] 2034 0
Other collaborator category [1] 252255 0
University
Name [1] 252255 0
University of Queensland
Address [1] 252255 0
School of Psychology
The University of Queensland
St Lucia QLD 4072
Country [1] 252255 0
Australia
Other collaborator category [2] 252256 0
University
Name [2] 252256 0
Queensland University of Technology
Address [2] 252256 0
School of Nursing
N Block, Floor 6
Queensland University of Technology
Kelvin Grove QLD 4059
Country [2] 252256 0
Australia
Other collaborator category [3] 252257 0
Hospital
Name [3] 252257 0
Royal Brisbane & Women's Hospital
Address [3] 252257 0
Geriatric Assessment & Rehabilitation Unit
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country [3] 252257 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271831 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 271831 0
Ethics committee country [1] 271831 0
Australia
Date submitted for ethics approval [1] 271831 0
23/08/2011
Approval date [1] 271831 0
07/03/2012
Ethics approval number [1] 271831 0
HREC/11/QRBW/347
Ethics committee name [2] 286946 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 286946 0
Ethics committee country [2] 286946 0
Australia
Date submitted for ethics approval [2] 286946 0
09/03/2012
Approval date [2] 286946 0
13/03/2012
Ethics approval number [2] 286946 0
2012000296

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

Contacts
Principal investigator
Name 27511 0
Address 27511 0
Country 27511 0
Phone 27511 0
Fax 27511 0
Email 27511 0
Contact person for public queries
Name 10766 0
Liz Arnold
Address 10766 0
The University of Queensland
K Floor, Mental Health Centre
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country 10766 0
Australia
Phone 10766 0
+61 7 3365 5147
Fax 10766 0
+61 7 3365 5488
Email 10766 0
[email protected]
Contact person for scientific queries
Name 1694 0
Gerard Byrne
Address 1694 0
The University of Queensland
K Floor, Mental Health Centre
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country 1694 0
Australia
Phone 1694 0
+61 7 3365 5148
Fax 1694 0
+61 7 3365 5488
Email 1694 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.