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Trial registered on ANZCTR


Registration number
ACTRN12618000844246
Ethics application status
Approved
Date submitted
16/05/2018
Date registered
18/05/2018
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ImpleMENTing meditatiOn into heart disease clinical settings (The MENTOR Study)
Scientific title
Meditation in healthcare for the secondary prevention of depression and anxiety in heart disease
Secondary ID [1] 294776 0
nil
Universal Trial Number (UTN)
U1111-1213-2716
Trial acronym
MENTOR
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Heart disease 307685 0
depression 307686 0
anxiety 307687 0
Condition category
Condition code
Alternative and Complementary Medicine 306753 306753 0 0
Other alternative and complementary medicine
Cardiovascular 306915 306915 0 0
Coronary heart disease
Cardiovascular 306917 306917 0 0
Other cardiovascular diseases
Mental Health 306919 306919 0 0
Depression
Mental Health 306920 306920 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials: An audio CD and a CD player will be used by the facilitator to guide participants through a meditation intervention. Participants will be given a copy of the audio CD, tape, USB stick or will be given access to a free online platform of the meditation intervention sent via an e-mail link for home practice. A topic guide will be used for the post-intervention focus groups that will occur in week 7 (Refer Appendix: Focus group and interview guide).
Procedure: This meditation intervention will consist of 6 consecutive weekly group sessions of 16 minutes duration in addition to conventional cardiac rehabilitation. Participants will be contacted the Friday before the meditation intervention (Refer Appendix: Participant Timeline). On arrival to cardiac rehabilitation on the first day of the intervention, participants will have their baseline measures evaluated. They will then complete their cardiac rehabilitation exercise sessions for that day. Following cardiac rehabilitation, participants will have their blood pressure and salivary cortisol levels reassessed (Refer Appendix: Study Design). Intervention participants will then be taken to a private room where the meditation intervention will be delivered. An audio CD will be used by the facilitator to guide participants through deep breathing, a ‘body scan’ that sequentially draws focused attention to body parts, followed by instrumental music designed to calm the mind and facilitate a meditative state. Participants will then sit in the shared space with the facilitator for 2 to 3 minutes before being gradually guided back to normal awareness.
Participants will be given a copy of the audio CD, tape, USB stick or access to a free online platform of the meditation intervention and advised to adhere to daily home meditation practice for 16 minutes at the same time and in the same place if possible. They will be asked to do this home meditation on each day that they are not attending the group meditation session (6 days per week for 6 weeks). Meditation practice should occur in a quiet space that is uninterrupted. This can be in the bedroom, outside in the garden or any other area, and can be made comfortable with a chair, pillows or a bed. Participants will be asked to complete a log sheet of the number of home meditation sessions completed, including date, duration, and location of their meditation practice. The log sheets will be collected by the research team weekly. The number of online home practice sessions and the duration of these sessions will be tracked by the research team.
In week 7, participants will be invited to participate in focus groups consisting of 6 to 8 adults. A copy of the interview guide for these focus groups is outlined in the Appendix (Participant focus group and interview guide). An opportunity for a short personal interview will be given after the focus group to allow participants to share information they may not have been comfortable sharing within the group about their experiences with meditation or environmental or lifestyle factors affecting their participation. No incentives will be offered for participation.
Strategies to improve adherence
At the group meetings, before each meditation session, the facilitator will lead a short 1-2 minute per person check in’ to identify any issues or challenges participants are having with the practice. Prior to the first meditation, a short explanation of the steps involved in the meditation will be explained to participants, and participants will have an opportunity to share what they are hoping to gain by using meditation. Participants will be reassured that initially, chatter that occurs within the mind can be difficult to quieten and that this is part of the process, but as practice continues, it becomes easier over time to quiet the mind.
A record of de-identified screening statistics and key dates (for example, study ID, date of recruitment, allocation, site, date of intervention, and attendance in the number of weeks will be kept by the research team). Participants allocated to the intervention group will be contacted the day before, or the Friday prior (for Monday sessions) to the commencement of the group meditation intervention and reminded of the date, time, and venue (refer to Participant Timeline in Appendices).
A free online platform will be created to allow participants to log in to the meditation website and complete their assigned home practice if they prefer this mode of delivery (as opposed to a CD player). This online platform will automatically tabulate the number of sessions completed according to the times logged in to complete meditation practice. Follow up telephone calls will be made to participants or an online survey link generated via REDCap will be sent to participants' e-mail address at 3 months regarding mental health and well-being, and whether participants had chosen to continue to use meditation outside of the intervention period. Whilst participants may decide to keep a personal diary of experiences during meditation, this data will not be collected.
Both the meditation intervention group and usual care control group will be able to participate in cardiac rehabilitation. There will be no alteration to their cardiologist or other outpatient follow up appointments or medications unless advised by the relevant health professional, nor restrictions to use of other complementary and alternative therapies.

Who will deliver the intervention: This meditation intervention will be delivered by a registered nurse and researcher with extensive (over 13 years) acute clinical nursing experience. She has conducted a previous Australian Research Council Category 1 funded study in the same cardiac rehabilitation setting and has completed online Good Clinical Practice Training for Investigational Sites and Sponsors provided by ARCS Australia. The researcher also has over 13 years’ meditation practitioner experience, including completion of the 8 week Mindfulness Based Stress Reduction course, completion of a 2.5 day silent meditation retreat, fortnightly attendance at a closed group meditation for over 13 years, and has an established personal meditation practice. Focus groups will be facilitated by a member of the research team with extensive clinical research and qualitative research experience.

Mode of intervention delivery: This meditation intervention will consist of 6 weekly face to face group sessions of 16 minutes duration in addition to conventional cardiac rehabilitation. In addition, participants will be given a copy of the audio CD, tape, USB stick or access to a free online platform sent via e-mail link of the meditation intervention and advised to adhere to daily home meditation practice for 16 minutes at the same time and in the same place if possible. Participants will be asked to do this home meditation on each day that they will not attend the group meditation sessions.
At week 7, participants will be invited to participate in focus groups consisting of 6 to 8 adults. An opportunity for a short personal interview will be given after the focus group to allow participants to share information they may not have been comfortable sharing within the group about their experiences with meditation or environmental or lifestyle factors affecting their participation.
Follow up telephone calls will be made to participants or an online survey link will be sent to participants' e-mail address at 3 months regarding mental health and well-being, and whether participants had chosen to continue to use meditation outside of the intervention period.

The number of times the intervention was delivered: This meditation intervention will be delivered on the Monday morning after participants have completed their cardiac rehabilitation exercise program for that day. Prior to the meditation intervention, the researcher will facilitate a 1-2 minute per person check in with the group to ascertain how each participant is going and any difficulties they are having with their meditation practice. The group meditation intervention will be of 16 minutes duration. Participants will then sit in the shared space with the facilitator for 2 to 3 minutes before being gradually guided back to normal awareness. The meditation intervention will be delivered weekly for six consecutive weeks. Participants will be asked to do home meditation practice on each day that they will not attend the group meditation sessions (6 days per week for 6 weeks). Participants will return in week 7 to participate in a focus group of 30 minutes to 1-hour duration.

Location: This study took place at a large tertiary referral hospital in Western Sydney, which is a residential area that is culturally diverse and socioeconomically disadvantaged. The meditation sessions will be held in a private meeting room adjacent to the outpatient cardiac gym or in a second private room separate to the inpatient cardiology wards. Doors and windows will be closed to minimise outside noise. Lighting will be dimmed or switched off, and blinds will be closed to inhibit distracting light. Participants will be seated in comfortable chairs that will be set up in a circle.
Meditation home practice was advised to occur in a quiet space that was uninterrupted. This could be in the bedroom, outside in the garden or any other area, and participants could be made comfortable with a chair, pillows or a bed.

Tailoring: This was a set protocol. There was no set titration.
Intervention code [1] 301214 0
Behaviour
Intervention code [2] 301216 0
Lifestyle
Comparator / control treatment
Active control group: Standard care
The standard care control group will be contacted prior to commencing their exercise session. Baseline measures will be completed by the researcher prior to commencing their first cardiac rehabilitation exercise session. Conventional cardiac rehabilitation exercise sessions will be undertaken according to national guidelines (Woodruffe et al., 2015). In week one and week six, blood pressure and cortisol will be reassessed after exercise and 16 minutes later. Questionnaires will also be re-assessed at week 6, and via telephone at 3 months follow up (Refer Appendix: Study Design).

Participants from the standard care control group who wish to participate in the meditation intervention will also receive one group meditation session, and a meditation CD, USB or tape recording which they will be able to keep and integrate into home practice as desired. This will occur at the end of the trial period after follow-up data is collected (3 months).

The standard care control group will be able to participate in cardiac rehabilitation. There will be no alteration to the cardiologist or other outpatient follow up appointments or medications unless advised by the relevant health professional, nor restrictions to use of other complementary and alternative therapies.

Woodruffe et al. 2015. Australian Cardiovascular Health and Rehabilitation Association (ACRA) Core Components of Cardiovascular Disease Secondary Prevention and Cardiac Rehabilitation 2014. Heart, Lung and Circulation, vol. 24, (5), p. 430-441
Control group
Active

Outcomes
Primary outcome [1] 305891 0
Depression as measured by the Depression, Anxiety, Stress (DASS-21) depression subscale
Timepoint [1] 305891 0
6 weeks post-intervention commencement
Secondary outcome [1] 346913 0
Anxiety as measured by the Depression Anxiety Stress (DASS-21) anxiety subscale
Timepoint [1] 346913 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [2] 346914 0
Depression as measured by the Hospital Anxiety and Depression Scale (HADS) depression subscale
Timepoint [2] 346914 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [3] 346915 0
Stress as measured by the Depression Anxiety Stress (DASS-21) Stress subscale
Timepoint [3] 346915 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [4] 346917 0
Self-efficacy as measured by the Mindfulness Self-Efficacy Scale-Revised (MSES-R)
Timepoint [4] 346917 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [5] 346918 0
Quality of life as measured by the Global Quality of Life scale
Timepoint [5] 346918 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [6] 346919 0
Depression as measured by the Depression Anxiety Stress (DASS-21) depression subscale
Timepoint [6] 346919 0
3 months post-intervention commencement
Secondary outcome [7] 346920 0
Blood pressure as measured by Omron calibrated portable blood pressure machines.
Timepoint [7] 346920 0
Week 1, and week 6 post-intervention commencement
Secondary outcome [8] 346921 0
Stress as measured by salivary cortisol levels.
Salivary cortisol samples will be collected by Sarstedt Salivette (salivary cortisol) tubes with a chewable disc. Salivary cortisol sample tubes will be cooled for transportation, refridgerated, centrifuged and measured in a clinical laboratory.
Timepoint [8] 346921 0
week 1, and week 6 post-intervention commencement
Secondary outcome [9] 346922 0
Hospitalisation and readmissions as measured by online medical records.
Timepoint [9] 346922 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [10] 346999 0
Anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) anxiety subscale
Timepoint [10] 346999 0
6 weeks and 3 months post-intervention commencement

Eligibility
Key inclusion criteria
Eligibility Criteria

1. Adults aged 18 or older who have been referred to CR following an acute or chronic cardiac event, or for lifestyle modification;

2. Have at minimum mild to severe depression (DASS-21 score greater than or equal to 5), and/or anxiety (DASS-21 score greater than or equal to 4). People who are currently receiving psychological support and/or medication for their depression and/or anxiety are eligible for inclusion.

3. Willing to give informed consent, and participate in a 6-week group meditation program, adhere to daily home meditation practice using provided resources (CD) and be followed up for 12 months;

4. Level of English literacy to allow completion of study instruments with minimal assistance.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults with congenital heart disease

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)
The randomisation sequence will be uploaded to RedCap by a member of the research team who will not be involved in screening, recruitment, outcome assessment or intervention delivery. Participants will be randomised after participant ID and baseline data is entered into RedCap by a member of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent biostatistician will create a computer-generated block randomisation sequence for participants enrolled in the trial.
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
Sample Size
This pilot study aims to recruit 30 participants, 15 to the control arm (Group A), and 15 to the intervention arm (Group B), which is an acceptable number for pilot and feasibility studies (25). There are no previous studies of this particular meditation intervention conducted in the Australian cardiac rehabilitation setting.

Statistical analysis: Data will be analysed using descriptive and inferential statistics. All analyses will be on the basis of intention to treat. Student t-tests will be used for continuous data and chi-squared tests will be used for categorical outcomes in univariate analyses. Scores derived from psychometric measures for depression, anxiety, and stress, social readjustment are all measured on continuous scales. Non-parametric tests, such as the Kruskal Wallis test will be applied for comparing means in non-normally distributed variables. Pearson’s correlation for continuous variables will be used to test for associations of selected demographic, social and clinical variables with the sub-scales and total scale scores for each of the measures. The incidence of readmissions (and 95% confidence intervals) will be calculated for both intervention and control group. The significance level will be set at p<0.05. Data analysis will be supervised by a biostatistician who will be blinded to treatment allocation and have no part in the implementation of the intervention and endpoint assessment. Qualitative data generated from focus groups and individual interviews will be recorded, transcribed, and themes analysed using general inductive analysis. Data will be de-identified data will be coded into themes. Themes will be checked by a second researcher.

Recruitment
Recruitment status
Suspended
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
Recruitment hospital [1] 10895 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 22661 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 299383 0
University
Name [1] 299383 0
University of Technology Sydney
Address [1] 299383 0
IMPACCT, Faculty of Health
University of Technology Sydney
Building 10, level 3.
PO Box 123 Ultimo NSW 2007
Country [1] 299383 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
IMPACCT, Faculty of Health
University of Technology Sydney
Building 10, Level 3
PO Box 123 Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 298661 0
Hospital
Name [1] 298661 0
Western Sydney Local Health District (Blacktown Hospital)
Address [1] 298661 0
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148
Country [1] 298661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300284 0
Western Sydney Local Health District Human Research Ethics Committee Approval
Ethics committee address [1] 300284 0
WSLHD Research and Education Network,
Westmead Hospital,
176 Hawkesbury Road,
Westmead NSW 2145
Ethics committee country [1] 300284 0
Australia
Date submitted for ethics approval [1] 300284 0
12/10/2017
Approval date [1] 300284 0
26/01/2018
Ethics approval number [1] 300284 0
HREC/17/WMEAD/495
Ethics committee name [2] 300386 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [2] 300386 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [2] 300386 0
Australia
Date submitted for ethics approval [2] 300386 0
14/03/2018
Approval date [2] 300386 0
20/04/2018
Ethics approval number [2] 300386 0
ETH18-2337

Summary
Brief summary
This project aims to improve care for adults with heart disease by building the evidence for meditation as an adjunct non-pharmacological self-management strategy to improve health-related outcomes for adults after an acute cardiac event. This meditation intervention aims to provide an avenue for optimising self-management of depression and anxiety symptoms, known to be high after an acute cardiac event or hospitalisation, which may enhance the capacity for adults to adhere to conventional exercise-based CR, self-manage their symptoms and reduce re-hospitalisation rates.
The proposed study design is an open-label parallel group pilot RCT with post-intervention follow up. The researchers hypothesise that a meditation intervention will improve self-reported depression and anxiety at 6 weeks, which will be sustained at 3-month follow-up. Post-intervention follow-up will be undertaken to better understand consumer perspectives of meditation as an adjunct strategy for the alleviation of depression and anxiety symptoms.

Findings from this study will inform a phase III randomised controlled trial (RCT) that will be used to inform future policy and guideline development.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2707 2707 0 0
/AnzctrAttachments/375025-ANZCTR. Study design.docx (Supplementary information)
Attachments [2] 2708 2708 0 0
/AnzctrAttachments/375025-ANZCTR. MENTOR Participant timeline.docx (Supplementary information)
Attachments [3] 2710 2710 0 0
/AnzctrAttachments/375025-180227 - 5398 Newton.pdf (Ethics approval)
Attachments [4] 2711 2711 0 0

Contacts
Principal investigator
Name 83158 0
A/Prof Louise Hickman
Address 83158 0
IMPACCT
Faculty of Health
University of Technology Sydney
Building 10, level 3
PO Box 123
Ultimo NSW 2007
Country 83158 0
Australia
Phone 83158 0
+61 414530358
Fax 83158 0
Email 83158 0
angela.rao@uts.edu.au
Contact person for public queries
Name 83159 0
Ms Angela Rao
Address 83159 0
IMPACCT, Faculty of Health
University of Technology Sydney
Building 10, level 3
PO Box 123 Ultimo NSW 2007
Country 83159 0
Australia
Phone 83159 0
+61 414530358
Fax 83159 0
Email 83159 0
angela.rao@uts.edu.au
Contact person for scientific queries
Name 83160 0
Ms Angela Rao
Address 83160 0
IMPACCT, Faculty of Health
University of Technology Sydney
Building 10, level 3
PO Box 123 Ultimo NSW 2007
Country 83160 0
Australia
Phone 83160 0
+61 414530358
Fax 83160 0
Email 83160 0
angela.rao@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available to the public. Outcome data will be reported in a publication at the completion of the trial.
What supporting documents are/will be available?
Informed consent form
Ethical approval
Summary results
No Results