Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001110875
Ethics application status
Approved
Date submitted
9/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of a group Mindfulness-based intervention for Tamaki Health patients
Scientific title
A pilot study of a group Mindfulness-based intervention to improve the mental wellbeing of Tamaki Health patients
Secondary ID [1] 304747 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 322780 0
anxiety 322781 0
stress 322782 0
post-traumatic stress disorder 322784 0
chronic pain 322785 0
Condition category
Condition code
Mental Health 320367 320367 0 0
Depression
Mental Health 320368 320368 0 0
Anxiety
Mental Health 320369 320369 0 0
Other mental health disorders
Other 320370 320370 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot study of a group face-to-face Mindfulness intervention to assist participants to manage a range of physical and mental health issues. The Mindfulness intervention (Aotearoa Mindfulness and Awareness (AMA) Programme) is based in Mindfulness Based Stress Reduction (MBSR) and Mindfulness Based Cognitive Therapy (MBCT) programmes, and has been run by Tamaki Health in Auckland for the past 7 years. The programme will be delivered in 6 x 2.5 hour sessions across 6 weeks at various locations across Auckland. The study will involve 50-100 participants. The programme will be administered by mindfulness trained therapists (facilitators) who have received substantial training in both mental health and in the Mindfulness intervention.

The Mindfulness sessions are summarised below:
1. Introduction of facilitator, session structure, introduction to mindfulness, centering breath and mindful eating
2. Mindfulness in daily life, chair yoga, walking meditation
3. Resilience, body scan meditation
4. Coping with grief, self-compassion, open heart meditation, loving-kindness meditation
5. Assertive communication, mindful listening,
6. Mindful life and action planning, mindfulness practices (decided by participants)

The group members will be encouraged to complete all sessions but are able to withdraw consent to participate at any time. Successful completion will be considered attendance at 5 out of the 6 sessions. A register will be maintained noting attendance or absence.
Brief homework exercises will be provided for completion between sessions based on guided meditation exercises sent via MP3 links or on a CD according to the participant’s preference. These exercises have been developed specifically for the AMA programme and comprise mindfulness tasks ranging from 3 minutes (the breathing space meditation) to 28 minutes (the body scan meditation).
The suggested duration of homework practice for participants is: 15 minutes per day in Week 1, 30 minutes per day in Week 2, and 30-45 minutes per day for the remainder of the course and after its completion. There will be no formal monitoring of adherence to homework practice. The duration of practice sessions are suggestions only; completion of homework practice is ultimately up to participants to self-monitor.
Workbooks and handouts will be given to participants with the content of each session and reminders of the techniques they have learnt for their ongoing home-based practices. All materials used in the course, including workbooks and handouts, are provided to all AMA course participants, and their provision is not reliant on them taking part in the research study. These materials have been developed specifically for the AMA course by Tamaki Health over the 7 years it has been run and are only available to AMA course participants.
Ten participants taking part in the research study will also be invited to take part in a telephone interview so that the researchers can ask about participants’ experience of taking part in the AMA course. Participants can agree on the Consent Form whether they would like to take part in an interview. Interview participants will be randomly selected from all study participants who commence the AMA course and who have agreed to take part in an interview, including those who did not complete the course. The randomisation process and the conduct of the interviews will be undertaken by the study's principal investigator, who does not have any involvement in the facilitation of the AMA course. Recruitment of interviewees will continue until ten interviews have been conducted. The interview will be audio-recorded and transcribed.
Intervention code [1] 321124 0
Treatment: Other
Intervention code [2] 321233 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328211 0
Scores on Patient Health Questionnaire.
The Patient Health Questionnaire will be administered at the commencement of the intervention, and again at completion of the 6 weeks of the intervention.
Timepoint [1] 328211 0
(i) Baseline;
(ii) At the conclusion of the 6th session of the programme (6 weeks post-intervention commencement)
Secondary outcome [1] 398076 0
Scores on Cognitive and Affective Mindfulness Scale-Revised.
The Cognitive and Affective Mindfulness Scale-Revised will be administered at the commencement of the intervention, and again at completion of the 6 weeks of the intervention.
Timepoint [1] 398076 0
(i) Baseline;
(ii) At the conclusion of the 6th session of the programme (6 weeks post-intervention commencement)
Secondary outcome [2] 398087 0
Expectations of and perceptions about the intervention
A subsample of 10 participants will be interviewed by telephone, giving them the opportunity to discuss whether their expectations of the programme were met, what they liked/disliked about the programme, and the impact of attending the programme on their everyday lives. This will be a semi-structured one-on-one interview lasting approximately 20 minutes. The interviews will be audio-recorded and transcribed in full.
Timepoint [2] 398087 0
Within one-two weeks following completion of the 6 week programme.

Eligibility
Key inclusion criteria
Are able to give informed consent
Register for and attend the AMA Wellness course through Tamaki health
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria for the study once they have registered for the AMA Wellness course. However, participants are excluded from the AMA Wellness course run by Tamak Health due to -
• Active substance dependance – illegal or illicit (excluding cannabis use)
• Inadequate comprehension of the language the course is delivered in
• Forensic concerns leading to participants’ risk to others as assessed by clients’ clinician
• Suicidality and self-harm – participants’ have a plan and/or intent or have recently attempted
• Psychosis unless assessed by a psychiatrist as stable/ symptom-free
• PTSD – unless assessed by AMA clinical lead as suitable

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The present study is a pilot study hence the statistics will be limited to descriptive statistics (mean, sd, frequency distribution) for the assessment measures and correlations between baseline and post-intervention scores. These analyses will permit a power calculation should a Randomized Controlled Trial be conducted in the future.
Inductive thematic analysis will be used to identify themes and patterns in the qualitative data from the telephone interviews.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2021
Date of last participant enrolment
Anticipated
31/08/2021
Actual
Date of last data collection
Anticipated
14/10/2021
Actual
Sample size
Target
100
Accrual to date
41
Final
Recruitment outside Australia
Country [1] 23952 0
New Zealand
State/province [1] 23952 0
Greater Auckland

Funding & Sponsors
Funding source category [1] 309119 0
University
Name [1] 309119 0
Auckland University of Technology
Country [1] 309119 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 310069 0
None
Name [1] 310069 0
Address [1] 310069 0
Country [1] 310069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308987 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308987 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 308987 0
New Zealand
Date submitted for ethics approval [1] 308987 0
16/05/2021
Approval date [1] 308987 0
11/06/2021
Ethics approval number [1] 308987 0
21/NTB/141

Summary
Brief summary
This research is a pilot study investigating the impact of a 6 week Mindfulness intervention on participants’ wellbeing. The intervention - the Aotearoa Mindfulness and Awareness (AMA) course - is a programme offered through the primary health organization, Tamaki Health. The AMA course is an evidence-based, transdiagnostic, trauma-informed programme based on Mindfulness Based Stress Reduction that has supported clients of Tamaki Health for over seven years. The study hypothesis is that the mindfulness intervention will result in an improvement to participants’ scores on the Patient Health Questionnaire compared to their baseline scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112566 0
Ms April Kerslake
Address 112566 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 112566 0
New Zealand
Phone 112566 0
+64 9 2747823
Fax 112566 0
Email 112566 0
[email protected]
Contact person for public queries
Name 112567 0
Dr Wendy Wrapson
Address 112567 0
Auckland University of Technology
AR345
Level 3, AR Building
90 Akoranga Drive
Northcote
Auckland 0627
Country 112567 0
New Zealand
Phone 112567 0
+64 9 9219999
Fax 112567 0
Email 112567 0
[email protected]
Contact person for scientific queries
Name 112568 0
Dr Wendy Wrapson
Address 112568 0
Auckland University of Technology
AR345
Level 3, AR Building
90 Akoranga Drive
Northcote
Auckland 0627
Country 112568 0
New Zealand
Phone 112568 0
+64 9 9219999
Fax 112568 0
Email 112568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.