Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001404819
Ethics application status
Approved
Date submitted
27/08/2021
Date registered
18/10/2021
Date last updated
4/10/2022
Date data sharing statement initially provided
18/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness-Based Cognitive Therapy to reduce stress for family carers of relatives living with dementia- an intervention study
Scientific title
Mindfulness-Based Cognitive Therapy to reduce stress for family carers of relatives living with dementia- A quasi-experimental feasibility study using mixed methods
Secondary ID [1] 305076 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carer stress 323297 0
Condition category
Condition code
Mental Health 320863 320863 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-Based Cognitive Therapy (MBCT)
This is a non-drug intervention which uses teaching of cognitive skills to reduce mental distress.
A pack of written materials will be used by the instructor, and another pack of written materials will be given to the participants. The pack of written materials used by the instructor is to ensure fidelity and have been specifically designed for this study. The resources for the participants are designed to be home reading and support for home practice. Some of these will be taken from the guilford publications website (https://www.guilford.com/segal2-forms) which are a resource available to all purchasers of the MBCT instruction manual, Mindfulness-Based Cognitive Therapy for Depression, Second edition by Segal, Williams and Teasdale. The rest of the participant resource pack will be materials specifically designed for this study.

There are 8 sessions, each lasting 2.5 hours, delivered weekly consisting of activities such as guided meditation practices, group and pair discussions, written exercises and home practice. The home practice will involve brief readings as well as formal and informal practices. The readings will usually be summaries of the sessions to consolidate new knowledge as well as instructions for practices. In some weeks there will be written exercises to complete. In all weeks there will be an invitation to do a guided practice for about 30 minutes using a drop box link to an audio file recorded specifically by the lead researcher for this study. Alternatively, participants will be able to use a CD or a website link to guilford.com for standard MBCT audio-files if they don't wish to use drop box. The duration of all home practice will be upto 45 min per day for 6 out of 7 days of the week but it is not a requirement of the study that this amount of practice is adhered to. Every week participants will fill out a home practice record to monitor the amount of home practice being done. We will also encourage adherence by exploring barriers to practice at each session.

There will be an optional follow up booster session 3 months after the intervention.
One of the practices will involve eating a raisin.
There will be some movement based practices as well.
They will be run in person. Zoom will be an option for carers who cannot attend in person, or if there is a pandemic related lockdown/social restriction. We will provide zoom training for any participants who wish to have this.
They will be delivered by the lead researcher who is an experienced psychiatrist, trained in MBCT, and with a year of experience. They will be supervised by a more experienced MBCT trainer. There will also be a co-facilitator to assist who will have a background in health care, and training to manage any distress experienced by participants.
The location for the intervention will be a community venue.

The intervention is planned to be personalised a little to individuals, and adaptations may happen for the entire group. There will be an intake interview where personal details of each participant are collected to assess suitability and need to tailoring of the intervention. This is particularly around the area of trauma histories where the MBCT instructor/lead researcher needs to be aware any potential for distress that may be incurred by elements of the MBCT intervention. If significant trauma histories are gathered for individual participants, the MBCT instructor will be careful to check the progress of these participants and be vigilant for any distress that may be triggered. There may also be adaptations of the MBCT for the entire group depending on how the group experiences the MBCT. This is because MBCT has never been delivered for family carers of people with dementia in NZ before, and therefore they may be adaptations that are necessary as we go along. The MBCT instructor will be receiving supervision weekly from a highly trained MBCT supervisor, and will be making any necessary adjustments to the intervention for individuals and the group in consultation with this person, and documenting these carefully.

Intervention fidelity will be assessed by getting an independent researcher (with expertise in MBCT) to check the elements of the MBCT programme on a fidelity checklist against an audio-recording of each MBCT session. This will be done weekly as the intervention progresses. If any elements are not covered, then this researcher will notify the MBCT instructor who will make sure they cover it in the next session.

The size of the group will be 15 participants. There will also be 1 psychiatrist, 1 co-facililator and possibly 1-2 other members of the research team to help with set up and research tasks.
Intervention code [1] 321473 0
Treatment: Other
Intervention code [2] 321474 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328656 0
change in stress as measured by change in Perceived Stress Scale
Perceived Stress Scale will be used which is a validated measure used in similar studies
Timepoint [1] 328656 0
will be measured at baseline, post-intervention completion 8 weeks (primary timepoint) and 3 months after intervention completion
Secondary outcome [1] 399833 0
change in depression/anxiety as measured by the depression anxiety stress scales-21
this is also a validated measure
Timepoint [1] 399833 0
will be measured at baseline, post intervention completion 8 weeks and 3 months after intervention completion
Secondary outcome [2] 399834 0
change in burden as measured by the Zarit Burden Inventory-12 between baseline and post-intervention
this is validated measure and shorter than the popular version
Timepoint [2] 399834 0
at baseline, post-intervention completion 8 weeks and 3 months after intervention completion
Secondary outcome [3] 399835 0
change in wellbeing as measured by the Warwick Edinburgh Mental Wellbeing Scales between baseline and post-intervention
This is a validated measure
Timepoint [3] 399835 0
baseline, post-intervention completion 8 weeks and 3 months after intervention completion
Secondary outcome [4] 399836 0
change in carer perception of behavioural and psychological symptoms of their relative with dementia as measured by the Neuro-Psychiatric Inventory Scores at baseline and post-intervention
This is a validated measure
Timepoint [4] 399836 0
baseline, post-intervention completion 8 weeks and 3 months after intervention completion
Secondary outcome [5] 399837 0
change in trait mindfulness as measured by the Five Facets of Mindfulness Questionnaire at baseline and post-intervention
this is validated measure
Timepoint [5] 399837 0
at baseline, post intervention completion 8 weeks and 3 months after intervention completion
Secondary outcome [6] 399838 0
change in self compassion as measured by the Self Compassion Scale
This is a validated measure
Timepoint [6] 399838 0
baseline, post-intervention completion 8 weeks, and 3 months after intervention completion
Secondary outcome [7] 399839 0
time spent doing formal practice recorded in minutes. This will be collected using participant self report in home record sheets.
Timepoint [7] 399839 0
recorded weekly during intervention, and an average weekly estimate will be asked for at the 3 month post intervention completion point
Secondary outcome [8] 399840 0
attendance rate as measured by recording attendance of participants at each session
Timepoint [8] 399840 0
will be checked weekly during intervention and at the booster session
Secondary outcome [9] 399841 0
acceptability of the MBCT programme as assessed by qualitative interviews
Timepoint [9] 399841 0
a focus group will be held in session 8 of the MBCT intervention and individual interviews will be conducted after the intervention is completed. The focus group will consist of all participants at session 8 of the intervention.
Secondary outcome [10] 399842 0
demand for intervention/ease of recruitment, This will be collected using an audit of study records.
Timepoint [10] 399842 0
this will be assessed at the recruitment stage, prior to intervention being delivered.
Secondary outcome [11] 401034 0
potential adverse effects as assessed by qualitative interviews and an audit of study records. Please note none have been reported in similar international studies, but an increase in distress is the most likely adverse effect.
Timepoint [11] 401034 0
this will be collected throughout the study duration as noted in study records. Specific enquiries will be made at the focus group interview to be held in session 8 of the MBCT intervention and individual semi-structured interviews will be conducted after the intervention is completed.
Secondary outcome [12] 401035 0
changes in carer mindfulness experience as assessed by qualitative interviews
Timepoint [12] 401035 0
a focus group interview will be held in session 8 of the MBCT intervention and individual semi-structured interviews will be conducted after the intervention is completed
Secondary outcome [13] 401036 0
practicalities of delivering the MBCT intervention given resources collected by using study records.
Timepoint [13] 401036 0
This will be assessed throughout the study
Secondary outcome [14] 401037 0
reasons for non-participation/non-attendance collected by using study records
Timepoint [14] 401037 0
This will be assessed throughout the study

Eligibility
Key inclusion criteria
Carers who are enrolled in Dementia Auckland, Dementia Prevention Research Clinic, the Selwyn Foundation and Enliven.
All participants will be English speaking family carers of people living with dementia (relatives or spouses/partners), aged >18 years, able to give informed consent, and able to leave person with dementia and travel to a community-based group intervention when attending in person. Carers need to be able to attend an intake interview, complete questionnaires pre and post intervention, intend to attend at least 6 out of 8 therapy sessions, and commit to trying to do some home practice in between sessions. There also needs to be evidence of dementia in the person being cared for if not under DA or the Dementia Prevention Research Clinic (ie GP or other health certification).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are carers who have significant cognitive impairment, unstable co-morbid medical conditions, acute psychosis, substance abuse or dependence, suicidal ideation, or a history of epilepsy or a first degree relative with epilepsy. Carers will also be excluded if their relative with dementia has been in aged residential care for more than 2 years but less than 2 years is acceptable for inclusion because we recognise the transition into aged residential care is stressful for carers. If on antidepressants, carers will be excluded if they are in the process of titrating up or tapering off.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
mixed-methods (quantitative and qualitative outcome measures) in a convergent study design
feasibility level study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a feasibility study so any efficacy data will only be preliminary. We will aim to recruit 15 carer participants. This number is calculated based on optimal size for an MBCT for carers intervention group, resource availability (including room sizes). It is not based on a sample size calculation to power a study to definitively assess efficacy.

Quantitative data will be entered onto an Excel spreadsheet and imported into IBM SPSS version 27 for statistical analysis. Descriptive statistics (median, mean, SD) will be calculated for all outcome measures at the three time points (T0,T1,T2) for the participants who complete at least 4 sessions. This number of sessions has been chosen because it was what was used in the large MBCT trial showing equivalence to antidepressants as the minimum MBCT dose 35. We will then examine the difference between the means of each outcome measure between time points (T1-T0, T2-T0, T2-T1) and look for any trends in the data. We will also use descriptive statistics to analyse recruitment and retention rates.

Qualitative data analysis:
This will include data from intake interviews, MBCT sessions, focus groups, post-intervention interviews, as well as written data from home record sheets.
Audio-recorded data will be transcribed, and then data will be analysed using a thematic analysis framework with the assistance of NVivo software. The phases of this include the lead researcher familiarising with the whole data set, generating initial codes using a general inductive approach, searching for themes, reviewing these themes, defining these themes, and finally producing a report. An audit trail will be kept in the process of data analysis. De identified quotations, where relevant to substantiate the main analytic findings, will be provided verbatim.

Other aspects of analysis:
Where multiple carers are involved in caring for a single person with dementia, then a primary carer for the family will be identified and only their data will be entered into the quantitative analysis. However, secondary carers can be included in the qualitative data collection.

The mixed methods convergent design means that quantitative and qualitative data are being collected simultaneously at the post-intervention phase. Integration of the two data sets will occur after each has been separately analysed to explain areas of corroboration. Where the data sets do not align, there is potential for new theory to be developed to explain discordant findings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2022
Actual
5/04/2022
Date of last participant enrolment
Anticipated
5/04/2022
Actual
5/04/2022
Date of last data collection
Anticipated
4/10/2022
Actual
30/08/2022
Sample size
Target
15
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 24050 0
New Zealand
State/province [1] 24050 0
Auckland

Funding & Sponsors
Funding source category [1] 309476 0
Government body
Name [1] 309476 0
Health Research Council of New Zealand
Country [1] 309476 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019 Auckland Mail Centre 1142
Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 310447 0
None
Name [1] 310447 0
Address [1] 310447 0
Country [1] 310447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309263 0
Health and Disability Ethics Committee
Ethics committee address [1] 309263 0
Ethics committee country [1] 309263 0
New Zealand
Date submitted for ethics approval [1] 309263 0
01/09/2021
Approval date [1] 309263 0
21/02/2022
Ethics approval number [1] 309263 0
2021 FULL 10983

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

Contacts
Principal investigator
Name 113542 0
Dr Emme Chacko
Address 113542 0
The University of Auckland
Private Bag 92019 Auckland Mail Centre 1142
Auckland
Country 113542 0
New Zealand
Phone 113542 0
+649 3797599
Fax 113542 0
Email 113542 0
e.chacko@auckland.ac.nz
Contact person for public queries
Name 113543 0
Emme Chacko
Address 113543 0
The University of Auckland
Private Bag 92019 Auckland Mail Centre 1142
Auckland
Country 113543 0
New Zealand
Phone 113543 0
+649 3797599
Fax 113543 0
Email 113543 0
e.chacko@auckland.ac.nz
Contact person for scientific queries
Name 113544 0
Emme Chacko
Address 113544 0
The University of Auckland
Private Bag 92019 Auckland Mail Centre 1142
Auckland
Country 113544 0
New Zealand
Phone 113544 0
+649 3797599
Fax 113544 0
Email 113544 0
e.chacko@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility level study without a control group. Therefore the data will not be useful to meta-analyse in the future.


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.