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Trial registered on ANZCTR


Registration number
ACTRN12617000413325
Ethics application status
Approved
Date submitted
14/03/2017
Date registered
22/03/2017
Date last updated
22/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
START caring for carers - individualised coping intervention program for carers of people with dementia.
Scientific title
Caring for Carers: Examination of a manualised coping program (START) in reducing symptoms of depression, anxiety and carer burden in Australian carers of people with dementia.
Secondary ID [1] 291358 0
Nil known
Universal Trial Number (UTN)
U1111-1193-7955
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302340 0
Anxiety 302341 0
Condition category
Condition code
Mental Health 301924 301924 0 0
Depression
Mental Health 301925 301925 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will receive the START intervention therapy.
Start Caring for Carers is a manual based therapeutic intervention designed to improve coping skills, depression and anxiety in carers of people with dementia by teaching the carer to manage the behavioural and psychological symptoms of dementia (BPSD), as well as the stress associated with caregiving. It has been adapted from the Strategies for Relatives or START (developed by UCL) to suit the Australian context.
START Caring for Carers is comprised of 8 sessions delivered one on one over 8 to 16 weeks, either in person or via telehealth video conferencing. Mode of administration (either in person or via telehealth video conferencing) will be determined by participant preference and will be considered in acceptability of interventions. Each session takes approximate one hour to deliver and concludes with a relaxation component. Carers will have the flexibility to attend weekly or fortnightly sessions. Each carer will be issued with a copy of the Carer manual that includes in session material, between session tasks and support resources. Between session tasks comprise of practicing what is covered in session e.g., noting down behaviours observed and trying to generate antecedent to behaviour. It is estimated that between session tasks will be approximately 15 minutes in duration. The intervention will be provided by provisionally registered psychologists currently enrolled in the Master of Clinical Psychology at the University of Newcastle. The therapists will be supervised by a Senior Clinical Psychologist. Each therapist will partake in a full day pre-intervention training session in the new intervention and weekly supervision. Therapist competency to deliver the program will be evaluated pre-intervention. Each therapist will receive a copy of the Leader Manual.
Sessions will be recorded and used by the supervisor to assess treatment fidelity.
Therapist will complete surveys pre-intervention, post session and post study to assess acceptability of the new intervention.
Intervention code [1] 297385 0
Behaviour
Intervention code [2] 297519 0
Treatment: Other
Comparator / control treatment
Cognitive Behaviour Therapy (CBT): an evidenced based intervention used for the treatment of depression and anxiety in Australia. CBT will comprise up to 12 sessions, 1 hour per session, weekly ideally, though could occur fortnightly, either in person or via telehealth video conferencing. Mode of administration (either in person or via telehealth video conferencing) will be determined by participant preference and will be considered in acceptability of interventions. The intervention will be provided by provisionally registered psychologists currently enrolled in the Master of Clinical Psychology at the University of Newcastle. The therapists will be supervised by a Senior Clinical Psychologist. Sessions will be recorded and used by the supervisor to assess treatment fidelity.
Control group
Active

Outcomes
Primary outcome [1] 301378 0
Change in clinical affective symptoms measured by the Hospital Anxiety Depression Scale (HADS).

Measurement will occur at baseline, post-intervention and 3 months follow up.
Timepoint [1] 301378 0
The primary endpoint is 3 months post treatment.
Primary outcome [2] 301381 0
Change in level of carer burden measured by the Zarit Burden Interview (ZBI).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [2] 301381 0
The primary endpoint is 3 months post treatment.
Primary outcome [3] 301440 0
Feasibility and acceptability is a composite primary outcome that will be measured by qualitative data collected by survey designed specifically for this study.

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [3] 301440 0
The primary endpoint is 3 months post treatment.
Secondary outcome [1] 332502 0
Change in level of carer strain measured by the Caregiver Strain Index (CSI).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [1] 332502 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [2] 332503 0
Change in clinical affective symptoms measured by the Depression, Anxiety and Stress Scale (DASS 21).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [2] 332503 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [3] 332505 0
Change in health status of carer measured by the Twelve Item Health Status Questionnaire (HSQ).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [3] 332505 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [4] 332507 0
Change in carer quality of life measured by World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF) Australian Version 2000.

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [4] 332507 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [5] 332508 0
Change in symptoms reported by carer in the person with dementia measured by the Neuropsychiatric Inventory (NPI).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [5] 332508 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [6] 332509 0
Change in symptoms reported by carer in Person with Dementia (PwD) measured by the Dementia Severity Rating Scale (DSRS).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [6] 332509 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [7] 332510 0
Change in quality of life reported by carer in PwD measured by the Quality of Life - Alzheimer's Disease questionnaire for caregivers (QoL-AD).

Measurement will occur at baseline, post-intervention, and at 3 months follow up.
Timepoint [7] 332510 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [8] 332512 0
Caregiver intervention expectation and experience is a composite secondary outcome that will be by qualitative survey questions designed specifically for this study.

Measurement will occur at baseline, pre and post sessions, post-intervention, and at 3 month follow up.
Timepoint [8] 332512 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [9] 332705 0
Therapist intervention experience is a composite secondary outcome that will be measured by qualitative survey questions designed specifically for this study.

Measurement will occur at baseline, pre and post sessions, post-intervention, and at 3 month follow up.
Timepoint [9] 332705 0
The secondary endpoint is 3 months post treatment.
Secondary outcome [10] 332706 0
Change in coping symptoms measured by the Brief COPE.

Measurement will occur at baseline, pre and post sessions, post-intervention, and at 3 month follow up.
Timepoint [10] 332706 0
The secondary endpoint is 3 months post treatment.

Eligibility
Key inclusion criteria
1) adult carer of person with a diagnosis of dementia;
2) basic English;
3) medically fit to participate;
4) scoring at or above moderate level severity on any domain of the Depression, Anxiety and Stress Scales (Geriatric Depression Scale or Hospital Anxiety and Depression Scale) /or a score >=7 on the Caregiver Strain Index or another carer burden scale or self-reporting high levels of distress associated with their caring role (as determined during standard clinical interview);
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) concurrent psychiatric illness other than on the affective spectrum;
2) current high risk suicidality (will be referred on);
3) significant cognitive difficulties that would prevent or interfere with learning and/or retaining new information
4) carers having less than daily contact with the care receiver.

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 will occur through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated using blocked randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimations were not conducted due to this research being in its pilot phase. However, we aim for a sample size of at least 30 participants per group based on pilot clinical feasibility trial recommendations in the literature (Johanson & Brooks, 2010).

Data will be analysed using a mixed methods approach. Quantitative feasibility data (e.g., affective symptoms and carer burden) will be analysed by examining treatment effects and individual reliable change indices. Given randomisation procedures are likely to result in inequality between groups pre-treatment, any observed differences will be taken into account in analyses. Qualitative feasibility data will be collected by survey instruments and analysed using thematic analysis.

Recruitment
Recruitment status
Not yet 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)
NSW

Funding & Sponsors
Funding source category [1] 295832 0
University
Name [1] 295832 0
University of Newcastle
Address [1] 295832 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 295832 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
The University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294680 0
None
Name [1] 294680 0
NA
Address [1] 294680 0
NA
Country [1] 294680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297114 0
Human Research Ethics Committee
Ethics committee address [1] 297114 0
Research Services
Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 297114 0
Australia
Date submitted for ethics approval [1] 297114 0
25/08/2016
Approval date [1] 297114 0
14/12/2016
Ethics approval number [1] 297114 0
H-2016-0299

Summary
Brief summary
Many carers of people with dementia develop affective symptoms of depression and anxiety as a result of their carer role. The START program has been shown to be effective in the UK context in improving these symptom in carers. This study seeks to: 1. Examine the acceptability of the START program in an Australian context as reported by therapists and carers of people with dementia including examination of: a) Adherence of therapists to the treatment manual and their perceptions about the value of the program and potential generalisability in the Australian context; b) Carers perceived acceptability of the program as reflected by their self-report and completion of all 8 sessions; c) Benefit to carers as measured by a decrease in depression, anxiety and carer burden, relative to the control (CBT) group. 2. Examine the feasibility of the START program in an Australian context by examining the practicality and viability of intervention delivered by provisionally registered psychologists from within an Australian university psychology clinic.
Trial website
Trial related presentations / publications
Public notes
Study is not powered for an RCT as it is a feasibility and acceptability study.
People receiving, assessing and analysing data will be blind to intervention type. All collection of data is blinded, the person assessing outcomes and analysing data will be blinded to quantitative data, but not blinded to qualitative data because some of the questions themselves (even though administered by qualtrics) may alude to which treatment was received. Also it is difficult to really ensure that qualitative data is interpreted 'objectively'. 

Contacts
Principal investigator
Name 73022 0
Dr Michelle Kelly
Address 73022 0
School of Psychology
Behavioural Sciences Building W132
The University of Newcastle (UON)
University Drive
Callaghan NSW 2308
Australia
Country 73022 0
Australia
Phone 73022 0
+61 2 49216 838
Fax 73022 0
+61 2 49216 980
Email 73022 0
michelle.kelly@newcastle.edu.au
Contact person for public queries
Name 73023 0
Mrs Karen Bell-Weinberg
Address 73023 0
School of Psychology
Behavioural Sciences Building W132
The University of Newcastle (UON)
University Drive
Callaghan NSW 2308
Australia
Country 73023 0
Australia
Phone 73023 0
+61 2 49216 838
Fax 73023 0
+61 2 49216 980
Email 73023 0
karen.bell@uon.edu.au
Contact person for scientific queries
Name 73024 0
Dr Michelle Kelly
Address 73024 0
School of Psychology
Behavioural Sciences Building W132
The University of Newcastle (UON)
University Drive
Callaghan NSW 2308
Australia
Country 73024 0
Australia
Phone 73024 0
+61 2 49216 838
Fax 73024 0
+61 2 49216 980
Email 73024 0
michelle.kelly@newcastle.edu.au

No data has been provided for results reporting
Summary results
Not applicable