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Trial registered on ANZCTR


Registration number
ACTRN12614000664640
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
25/06/2014
Date last updated
25/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of a single session behavioral activation intervention to improve wellbeing in non-depressed caregivers
Scientific title
In the non-depressed caregiver population, does a single session of behavioural activation intervention, compared to no intervention, boost wellbeing and reduce symptoms of depression and stress.
Secondary ID [1] 284819 0
Nil
Universal Trial Number (UTN)
U1111-1158-1452
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 292203 0
Stress 292204 0
Depression (sub clinical) 292205 0
Condition category
Condition code
Mental Health 292539 292539 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise of a single 90 minute session of Behavioral Activation. The intervention is adapted from the Brief Behavioural Activation Treatment for Depression manual (Lejuez et al, 2011) whereby participants are assisted to identify their key values across five life areas
(relationships, education/career, recreation/interests, physical health, spirituality) and then identify activities, or goals, within each area that they would like to engage in. Goals for engagement are set in a structured and hierarchical manner, starting with those most easily achievable, to assist participants to meet them. The intervention will be delivered on an individual basis, by a postgraduate clinical psychology student.

Following the intervention session there will be a two-week intervention period, in which participants will work toward goals and monitor progress using monitoring forms. At the end of the intervention period, participants will re-complete outcome measures of wellbeing, depression, stress.
Intervention code [1] 289611 0
Behaviour
Intervention code [2] 289612 0
Prevention
Comparator / control treatment
The intervention will be compared to a wait list control group. Individuals in the control group will receive the intervention once the intervention group has completed first follow up measures (completed 2 weeks following intervention). It is anticipated the control group will be on the 'wait list' for approximately 1 month before receiving intervention.
Control group
Active

Outcomes
Primary outcome [1] 292405 0
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item self report measure of mental wellbeing.
Timepoint [1] 292405 0
Baseline, and at 2 and 12 weeks after intervention session.
Primary outcome [2] 292406 0
Brief Wellbeing Scale (BWS) is a brief 22-item self report measure designed to assess subjective wellbeing
Timepoint [2] 292406 0
Baseline, and at 2 and 12 weeks after intervention session.
Primary outcome [3] 292407 0
Depression Anxiety Stress Scale- 21 items (DASS-21, a
21-item self-report measure that assesses depression, anxiety and stress in adults
Timepoint [3] 292407 0
Baseline, and at 2 and 12 weeks after intervention session.
Secondary outcome [1] 308877 0
Valued Living Questionnaire (VLQ) is a brief two-part self-report instrument designed to assess how consistently an individual is living their life values
Timepoint [1] 308877 0
Baseline, and at 2 and 12 weeks after intervention session.
Secondary outcome [2] 308878 0
Reward Probability Index (RPI) is a 20 item self-report measure that assesses the level of positive reinforcement (or reward) in an individual's environment.
Timepoint [2] 308878 0
Baseline, and at 2 and 12 weeks following intervention session.

Eligibility
Key inclusion criteria
Individuals who are the primary caregiver for a relative or person with a disability will be eligible to participate. There will be no exclusory criteria based on the type of disability that requires care, i.e. severe mental illness, dementia, developmental disability, so that carers across a variety of rolls will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who indicate clinical levels of pathology, either in initial screening process or subsequent screening, will not be eligible for the current study.

Study design
Purpose of the study
Prevention
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)
A spreadsheet column with equal parts study condition (intervention + control) will be sorted according to a randomly generated number sequence, using Microsoft excel software. Resulting in a randomly sorted list of study condition, to which participants will be allocated chronologically as they volunteer for the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis using G*power was calculated to determine the number of participants required for an 80% probability of capturing a ‘moderate’ interaction (i.e., f =.25) between group (intervention, control) and time (pre-test, post-test). According to G*Power, approximately 48 participants will be required (24 in each group). This was determined at an adjusted Bonferroni level of .0125.

Hypotheses will be tested with a series of Generalised Linear Mixed Models (GLMM). In order to optimise the likelihood of convergence, the GLMMs will be be tested separately for each of the outcome measures. To control for inflation of familywise errorrate, as a result of analysing each outcome independently of other, each GLMM will be evaluated at a Bonferroni adjusted alpha-level of .0125

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2014
Actual
Date of last participant enrolment
Anticipated
30/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289432 0
Self funded/Unfunded
Name [1] 289432 0
Ainsley Read
Country [1] 289432 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 288118 0
None
Name [1] 288118 0
Address [1] 288118 0
Country [1] 288118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291189 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291189 0
Curtin University
Kent St, Bentley WA 6102
Ethics committee country [1] 291189 0
Australia
Date submitted for ethics approval [1] 291189 0
16/05/2014
Approval date [1] 291189 0
10/06/2014
Ethics approval number [1] 291189 0
4738

Summary
Brief summary
The project will assess the utility of a single session behavioral activation intervention to improve wellbeing in a non depressed sample. To assess the possible preventative benefits of the treatment, the study will employ a sample of carers, who are hypothesised to be at increased risk of developing depressive symptomatology due to lifestlye factors such as high stress. It is predicted that a single session of behavioral activation will significantly improve wellbeing outcomes, as indicated on self report measures, compared to a waitlist control and that this pre/post improvement will be significantly maintained at follow up.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 89 89 0 0
/AnzctrAttachments/366553-Proposal_15May_AinsleyRead.pdf
Attachments [2] 90 90 0 0
/AnzctrAttachments/366553-Approval Letter .pdf

Contacts
Principal investigator
Name 49270 0
Dr Trevor Mazzucchelli
Address 49270 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 49270 0
Australia
Phone 49270 0
(+61 08) 92667182
Fax 49270 0
Email 49270 0
[email protected]
Contact person for public queries
Name 49271 0
Ainsley Read
Address 49271 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 49271 0
Australia
Phone 49271 0
+61 0400247207
Fax 49271 0
Email 49271 0
[email protected]
Contact person for scientific queries
Name 49272 0
Trevor Mazzucchelli
Address 49272 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 49272 0
Australia
Phone 49272 0
(+61 08) 92667182
Fax 49272 0
Email 49272 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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