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Trial registered on ANZCTR


Registration number
ACTRN12611000575932
Ethics application status
Approved
Date submitted
2/06/2011
Date registered
3/06/2011
Date last updated
3/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Anxiety and Depression in Distressed Carers for Persons with Dementia-related Conditions
Scientific title
Psychological Treatment of Anxiety and Depression using the Behavioural and Acceptance Based Therapy (BABT) program in Distressed Carers for Persons with Dementia-related Conditions
Secondary ID [1] 262300 0
Nil
Universal Trial Number (UTN)
U1111-1121-9274
Trial acronym
Behavioural and Acceptance Based Therapy (BABT) program for distressed carers
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 268008 0
Anxiety 268009 0
Condition category
Condition code
Mental Health 268138 268138 0 0
Depression
Mental Health 268139 268139 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to investigate whether the psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program is useful in helping individuals in a caregiving role, reduce their distress (including anxiety and depressive symptoms), as well as improve their overall quality of life.

The BABT intervention will be conducted by qualified psychologists in an individual face-to-face format and will consist of six consecutive weekly meetings, 1.5 hours each, plus two follow-up/booster sessions conducted at fortnightly intervals. Hence, the BABT program comprises a total of 8 sessions conducted over a 10 week period.

The BABT components will be administered in a standardized format to all participants. In particular, the BABT program will comprise the following components: (1) education about the common reactions to caring for a partner (or parent) with dementia; (2) acceptance and mindfulness based strategies to promote awareness and acceptance of internal sensations; (3) learning to deal with uncertainty; (4) behavioural/ experiential exercises to curtail avoidance reactions; and (5) re-evaluating and re-connecting with life-goals and values, as well as learning to engage/commit to pursuing valued activities.
Intervention code [1] 266691 0
Behaviour
Intervention code [2] 266692 0
Lifestyle
Comparator / control treatment
Wait-list control (WLC) condition. Participants in this condition will be offered the BABT program 3 -months (12 -weeks) following their initial screening assessment.
Control group
Active

Outcomes
Primary outcome [1] 266886 0
Depression: Beck Depression Inventory (2nd Ed) [BDI-II], sample mean scores to reduce to non-clinical levels (< 14)
Timepoint [1] 266886 0
Baseline, end of therapy (10 weeks following commencement of intervention), 1-month and 3 -months follow up (i.e., 14 and 26 weeks following commencement of intervention).
Primary outcome [2] 266887 0
Anxiety: State Trait Anxiety Scale (STAI), sample means scores to reduce to non-clinical levels [T scores < 60]
Timepoint [2] 266887 0
Baseline, end of therapy (10 weeks following commencement of intervention), 1-month and 3 -months follow up (i.e., 14 and 26 weeks following commencement of intervention).
Primary outcome [3] 266888 0
Acceptance: Acceptance and Action Questionnaire, sample mean scores will improve on acceptance subscale and reduce on experiential subscale.
Timepoint [3] 266888 0
Baseline, end of therapy (10 weeks following commencement of intervention), 1-month and 3 -months follow up (i.e., 14 and 26 weeks following commencement of intervention).
Secondary outcome [1] 276565 0
Caregiver Functionality: Positive Aspects of Caregiving Scale, sample means scores expected to improve.
Timepoint [1] 276565 0
Baseline, end of therapy (10 weeks following commencement of intervention), 1-month and 3 -months follow up (i.e., 14 and 26 weeks following commencement of intervention).
Secondary outcome [2] 276566 0
Coping strategies: BCOPE, sample means scores expected to improve on adapative coping and reduce on maladaptive coping.
Timepoint [2] 276566 0
Baseline, end of therapy (10 weeks following commencement of intervention), 1-month and 3 -months follow up (i.e., 14 and 26 weeks following commencement of intervention).
Secondary outcome [3] 276567 0
Quality of Life [QOL], SF-36: sample mean scores expected to increase reflecting improvment in QOL
Timepoint [3] 276567 0
Baseline, end of therapy (10 weeks following commencement of intervention), 1-month and 3 -months follow up (i.e., 14 and 26 weeks following commencement of intervention).

Eligibility
Key inclusion criteria
1) reporting at least moderate (sub-clinical or clinical) levels of anxiety and/or depressive symptoms; 2) CG for a person diagnosed with a dementia-related condition; 3) care recipient has a minimum of at least 12-month prognosis; 4) aged 18 to 80 years; 5) able to speak, read and write basic English; and 6) medically fit to respond to the assessment and intervention procedures.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Presence of severe cognitive and language deficits for CGs (defined as score < 1.96 SD below mean) that will be assessed via a brief screening neuropsychological assessment battery (see measures); (2) current or prior history of significant alcohol/ drug abuse or psychosis; (3) current suicidal ideation; and (4) currently undergoing psychiatric treatment for mental illness.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested persons are asked to contact the research team to obtain further information. Potentially eligible persons will be invited to take part in an initial screening assessment and if eligible for the therapy, they will be randomly allocated to commence the therapy program within 2 weeks following assessment, or be placed on a wait-list (control condition).

Participants will not be informed of their therapy condition allocation until after having completed the initial assessment. However allocation will not be concealed for the researcher allocating participants to the treatment conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by PC software.
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267179 0
Charities/Societies/Foundations
Name [1] 267179 0
Alzheimers Australia - Hazel Hawke Research Grant in Dementia Care
Address [1] 267179 0
Alzheimers Australia Research PO Box 4019 Hawker ACT 2614.
Country [1] 267179 0
Australia
Funding source category [2] 267180 0
University
Name [2] 267180 0
Macquarie University - Safety Net Grant
Address [2] 267180 0
Macquarie University
Research Office
C5C Research HUB
North Ryde, NSW 2109
Country [2] 267180 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Centre for Emotional Health
Department of Psychology
C3A, North Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 266253 0
None
Name [1] 266253 0
Address [1] 266253 0
Country [1] 266253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269174 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 269174 0
Macquarie University
Ethics Secretariat
Research Office
Level 3, Research HUB, Building C5C
Macquarie University
NSW 2109
Ethics committee country [1] 269174 0
Australia
Date submitted for ethics approval [1] 269174 0
Approval date [1] 269174 0
22/11/2010
Ethics approval number [1] 269174 0
5201001305

Summary
Brief summary
This study aims to evaluate the effect of a psychological treatment program on anxiety and depression in adults who are carers for persons with dementia-related conditions. Any carer who is experiencing distress and is looking after family members or relatives (including partners and parents) with dementia-related conditions may be eligible for this study.

Who is this study for?
You can join this study if you are aged 18 to 80 years and are caring for a family member or relative who has a dementia-related condition (e.g., Alzheimer’s). You must also be experiencing at least mild to moderate levels of anxiety and depressive symptoms for which you may or may not be taking medication.

Trial details:
Participants in this trial will be randomly (by chance) assigned to one of two groups. Participants in one group will undertake a psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program. This involves attending six consecutive weekly meetings of 1.5 hours each with a psychologist, followed by two follow-up sessions at fortnightly intervals. Participants in the other group will receive no psychological treatment for 12 weeks, after which time they will be offered the BABT program. Participants in both groups will be asked to complete questionnaires at 4 time-points throughout the study to assess whether the program is effective in helping them to reduce their distress and improve their overall quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32692 0
Address 32692 0
Country 32692 0
Phone 32692 0
Fax 32692 0
Email 32692 0
Contact person for public queries
Name 15939 0
Dr. Maria Kangas
Address 15939 0
Centre for Emotional Health,
Department of Psychology
C3A #717
Macquarie University
Sydney NSW 2109
Australia
Country 15939 0
Australia
Phone 15939 0
612 9850 8599
Fax 15939 0
Email 15939 0
maria.kangas@mq.edu.au
Contact person for scientific queries
Name 6867 0
Dr. Maria Kangas
Address 6867 0
Centre for Emotional Health,
Department of Psychology
C3A #717
Macquarie University
Sydney NSW 2109
Australia
Country 6867 0
Australia
Phone 6867 0
612 9850 8599
Fax 6867 0
Email 6867 0
maria.kangas@mq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results