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Trial registered on ANZCTR


Registration number
ACTRN12617001014347p
Ethics application status
Not yet submitted
Date submitted
12/07/2017
Date registered
14/07/2017
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness training for people after Stroke: a Feasibility Study
Scientific title
Mindfulness Training for people after Stroke: a Feasibility Study
Secondary ID [1] 292413 0
Nil
Universal Trial Number (UTN)
Trial acronym
MAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 303992 0
Depression 303995 0
Anxiety 303996 0
Fatigue 304017 0
Condition category
Condition code
Stroke 303332 303332 0 0
Haemorrhagic
Stroke 303333 303333 0 0
Ischaemic
Mental Health 303347 303347 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a modified Mindfulness Based Stress Reduction programme delivered by a Mindfulness trainer, Marlies Dorrestein. The programme will comprise weekly, individualised 45-minute sessions over six weeks, with brief, daily homework exercises to be completed between sessions. There will be one ‘top-up’ session at 4 weeks post-completion of the initial six week programme. Top-up or ‘booster’ sessions have been shown to be important for discussing any barriers encountered in implementing the intervention in everyday life and to facilitate long term outcomes. The sessions will be based on standard MT approaches but will emphasise simple, brief mindfulness exercises to minimise potential difficulties due to reduced executive function, impaired concentration or fatigue. Participants will be provided with examples of ways they can incorporate and apply these exercises into their daily life. Sessions will include education about stroke as well as mindfulness. Homework tasks will involve 5-10 minute, guided (i.e. DVD) mindfulness exercises that gradually increase the ‘dose’ over the duration of the programme. Handouts will be provided to participants as reminders of the techniques they have learnt and they will be supplied with a book (Mindfulness for Health) and accompanying DVD to guide their home-based practice. Grant Rix of the Mindfulness Education Group https://mindfulnesseducation.nz/about/ will meet with Marlies for one hour a week initially and then fortnightly by Skype for a maximum of 40 1 hour sessions to provide professional supervision and mentoring.

The study will be monitored to ensure data quality and to facilitate entry of participants into the study and subsequent adherence. The Study coordinator will set up and maintain a tracking sheet outlining date and outcome of contact with participants, and dates of completion of MT sessions to ensure documentation of outcome for all participants.
Intervention code [1] 298580 0
Rehabilitation
Intervention code [2] 298596 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302729 0
Our primary outcome measure is the Beck Depression Inventory 2nd Edition - BDI-II, an internationally used measure of depression severity validated with neurological samples. The BDI-II has a Minimal Clinically Important Difference (MCID) of 5.8. Participants must score above 14 on the BDI-II to participate in this study (i.e. score in the 'mild depression' range or above).
Timepoint [1] 302729 0
Five weeks after completion of the six week MT in the week following the single 'top-up' session.
Secondary outcome [1] 336838 0
Quality of life, assessed using the Stroke Specific Quality of Life Scale and EuroQol-5D-5L (EQ-5D-5L) to calculate quality adjusted life years (QALYs) for the cost utility analysis,
Timepoint [1] 336838 0
Five weeks after completion of the six week MT in the week following the single 'top-up' session.
Secondary outcome [2] 336863 0
Anxiety and Depression, assessed using the Hospital Anxiety and Depression Scale (HADS),
Timepoint [2] 336863 0
Five weeks after completion of the six week MT in the week following the single 'top-up' session.
Secondary outcome [3] 336864 0
Fatigue, assessed using Modified Fatigue Impact Scale (MFIS).
Timepoint [3] 336864 0
Five weeks after completion of the six week MT in the week following the single 'top-up' session

Eligibility
Key inclusion criteria
Participants must be 17 years of age or older and have experienced a stroke more than six months and less than five years ago. They will be experiencing low mood (as measured by having a Beck Depression Inventory-II score greater than 14), and are able to give informed consent.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include having unstable comorbid conditions; or severe cognitive and/or communication difficulties that would interfere with participation; or having a history of epileptic seizures or a first degree relative with epilepsy; or have current involvement in other psychological therapy; or are unable to communicate in English or read simple written instructions.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a feasibility study not a trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Twenty participants who are stroke survivors will be recruited for this single centre, single arm trial. There will be no control group, as the purpose of this study is to address the feasibility issues that may affect the viability of a full study including the study protocols, recruitment and retention rates rather than determine if the intervention is effective.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics (mean, sd, frequencies) for all pre- and post-intervention assessment measures (questionnaires) will be calculated and the correlations between pre- and post-scores calculated. This is a feasibility study and the data on the Beck Depression Inventory - II, our primary outcome measure, will be used to complete a power calculation prior to a full trial.

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 outside Australia
Country [1] 9048 0
New Zealand
State/province [1] 9048 0
Auckland

Funding & Sponsors
Funding source category [1] 296962 0
Government body
Name [1] 296962 0
Health Research Council
Address [1] 296962 0
P O Box 5541
Wellesley Street
Auckland 1141
Country [1] 296962 0
New Zealand
Primary sponsor type
University
Name
Research and Innovation Office, Auckland University of Technology
Address
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 295976 0
None
Name [1] 295976 0
Address [1] 295976 0
Country [1] 295976 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298167 0
Health and Disability Ethics Committee
Ethics committee address [1] 298167 0
Ministry of Health
P O Box 5013
Wellington 6140
Ethics committee country [1] 298167 0
New Zealand
Date submitted for ethics approval [1] 298167 0
20/07/2017
Approval date [1] 298167 0
Ethics approval number [1] 298167 0

Summary
Brief summary
Stroke is one of the leading causes of disability in New Zealand with long-lasting effects on quality of life including depression, anxiety and fatigue. Mindfulness training (MT) is a safe, easily-learned technique for reducing depression and anxiety and improving coping skills. This feasibility study aims to explore a number of practical issues in providing MT to people with stroke as well as addressing identified feasibility issues. Clarifying these issues will allow us to conduct a clinical trial to test whether MT is an effective method for improving the quality of life in people after a stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76202 0
Prof Richard Siegert
Address 76202 0
AUT University
90 Akoranga Drive
(Building AR - AR321)
Private Bag 92006
Auckland 1142
Country 76202 0
New Zealand
Phone 76202 0
+64-9-921 9999 ext 7885
Fax 76202 0
Email 76202 0
richard.siegert@aut.ac.nz
Contact person for public queries
Name 76203 0
Prof Richard Siegert
Address 76203 0
AUT University
90 Akoranga Drive
(Building AR - AR321)
Private Bag 92006
Auckland 1142
Country 76203 0
New Zealand
Phone 76203 0
+64-9-921 9999 ext 7885
Fax 76203 0
Email 76203 0
richard.siegert@aut.ac.nz
Contact person for scientific queries
Name 76204 0
Prof Richard Siegert
Address 76204 0
AUT University
90 Akoranga Drive
(Building AR - AR321)
Private Bag 92006
Auckland 1142
Country 76204 0
New Zealand
Phone 76204 0
+64-9-921 9999 ext 7885
Fax 76204 0
Email 76204 0
richard.siegert@aut.ac.nz

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