Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000486729
Ethics application status
Approved
Date submitted
11/04/2013
Date registered
1/05/2013
Date last updated
22/04/2020
Date data sharing statement initially provided
22/04/2020
Date results provided
22/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptance and commitment therapy: Evaluation of a novel approach to enhance the quality of life of aged care residents
Scientific title
Acceptance and commitment therapy: Evaluation of a novel approach to enhance the quality of life of aged care residents
Secondary ID [1] 282289 0
Nil known
Universal Trial Number (UTN)
U1111-1141-7451
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor quality of life
 288824 0
Depression 288825 0
Anxiety 288826 0
Condition category
Condition code
Mental Health 289181 289181 0 0
Depression
Mental Health 289368 289368 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 sessions of Acceptance and Commitment Therapy (ACT). The aim of ACT is to maximise a person’s potential for a rich, full and meaningful life. ACT does this by: a) teaching mindfulness skills, b) helping the client to clarify their values - then using that knowledge to guide, inspire and motivate the client to change their life for the better.

ACT will be administered in individual sessions (2 x 60 minute sessions per week for 6 weeks) by Doctor of Psychology (Clinical) candidates, under supervision from the research team. Attendence record will be kept and treatment adherence will be monitored in weekly supervision sessions.
Intervention code [1] 286925 0
Treatment: Other
Intervention code [2] 286926 0
Behaviour
Comparator / control treatment
No treatment (wait list control). This group will be offered the intervention after 2 months.
Control group
Active

Outcomes
Primary outcome [1] 289307 0
Increase in Lancaster Quality of Life Profile-Residential
Timepoint [1] 289307 0
Baseline, 7 weeks and 3 months after intervention commencement
Secondary outcome [1] 302195 0
Decrease in Geriatric Depression Scale-15 score
Timepoint [1] 302195 0
Baseline, and 7 weeks and 3 months after intervention commencement
Secondary outcome [2] 302196 0
Decrease in total score on Geriatric Anxiety Inventory
Timepoint [2] 302196 0
Baseline, and 7 weeks and 3 months after intervention commencement

Eligibility
Key inclusion criteria
Permanent resident in aged care facility.
Facility staff reports of mental health concern or adjustment difficulty or poor quality of life.
Fluency in English.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Substantial cognitive impairment (MMSE < 19).
Severe medical illness that would compromise participation in psychtherapy.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Wait list control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A Multiple Analysis of Covariance (MANCOVA) will be used to compare outcome measures at baseline and post-intervention. This method allows for comparison of multiple outcomes simultaneously, and also controls for any differences between groups in baseline scores.
Changes in outcome measures from post-intervention (i.e., follow-up data) will be recorded for the intervention group only (due to the difficulty of following two waves for 5 months within a 12 month study period). Repeated-measures t-tests will be employed.

A power analysis was performed using G*Power (version 3.1.4; Faul et al., 2007). For the scales chosen, a sample size of 26 can detect pre-post differences of an effect size of 0.5, with power exceeding 0.8, at alpha = 0.05 (two-sided). Our previous systematic review of psychotherapy in aged care settings reported a mean attrition rate of 19% (Davison et al., 2012). We will recruit 36 participants, to allow for a conservative estimate of 28% attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2013
Actual
10/04/2013
Date of last participant enrolment
Anticipated
19/07/2013
Actual
10/12/2013
Date of last data collection
Anticipated
Actual
10/04/2014
Sample size
Target
36
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287073 0
Charities/Societies/Foundations
Name [1] 287073 0
Lions John Cockayne Memorial Grant Trust Fund
Country [1] 287073 0
Australia
Primary sponsor type
Individual
Name
Dr Tanya Davison
Address
Aged Mental Health Research Unit, Monash University
Kingston Centre, Warrigal Road, Cheltenham, VIC 3192.
Country
Australia
Secondary sponsor category [1] 285848 0
Individual
Name [1] 285848 0
Prof Daniel O'Connor
Address [1] 285848 0
Aged Mental Health Research Unit, Monash University
Kingston Centre, Warrigal Road, Cheltenham, VIC 3192.
Country [1] 285848 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289088 0
Southern Health HREC
Ethics committee address [1] 289088 0
Ethics committee country [1] 289088 0
Australia
Date submitted for ethics approval [1] 289088 0
Approval date [1] 289088 0
09/04/2013
Ethics approval number [1] 289088 0

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

Contacts
Principal investigator
Name 39150 0
Dr Tanya Davison
Address 39150 0
Aged Mental Health Research Unit
Monash University
Kingston Centre
Warrigal Road
Cheltenham
VIC 3192
Country 39150 0
Australia
Phone 39150 0
+61 3 9265 1700
Fax 39150 0
Email 39150 0
[email protected]
Contact person for public queries
Name 39151 0
Tanya Davison
Address 39151 0
Aged Mental Health Research Unit
Monash University
Kingston Centre
Warrigal Road
Cheltenham
VIC 3192
Country 39151 0
Australia
Phone 39151 0
+61 3 9265 1700
Fax 39151 0
Email 39151 0
[email protected]
Contact person for scientific queries
Name 39152 0
Tanya Davison
Address 39152 0
Aged Mental Health Research Unit
Monash University
Kingston Centre
Warrigal Road
Cheltenham
VIC 3192
Country 39152 0
Australia
Phone 39152 0
+61 3 9265 1700
Fax 39152 0
Email 39152 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.