Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000607471
Ethics application status
Approved
Date submitted
24/04/2016
Date registered
10/05/2016
Date last updated
23/06/2021
Date data sharing statement initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Effectiveness of a Mindfulness-Based Change in Cognitive State in Reducing effects of Chronic Uncontrolled Reversible DisEases.
Scientific title
Evaluation of the Effectiveness of a Mindfulness-Based Program (MB-SMART) in Reducing Autonomic Stress Response in Subjects with Chronic Uncontrolled Reversible DisEases.
Short Title: Self-Managed Autonomic Regulation Therapy for Chronic Uncontrolled Reversible DisEases. SMART-CURE
Secondary ID [1] 287369 0
None
Universal Trial Number (UTN)
U1111-1173-7698
Trial acronym
SMART CURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive pulmonary disease 296044 0
Chronic Anxiety 298517 0
Autonomic dysfunction 298518 0
Hypertension 309172 0
Condition category
Condition code
Respiratory 296316 296316 0 0
Chronic obstructive pulmonary disease
Mental Health 296317 296317 0 0
Anxiety
Cardiovascular 298597 298597 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1-Interventional group. They receive mindfulness-based training of cognitive skills to self-manage causes and effects of the relevant chronic disease (COPD and /or hypertension). The training period is for 8 weeks and it includes homework in addition to their standard medical treatment for the chronic disease.
Arm 2-Control group. Receive only their standard medical treatment for either COPD and/or hypertension as usual.

Mindfulness Intervention
Mindfulness program is designed with practices with a specific emphasis on increasing awareness of mental activity (thoughts and emotions) and automatic behaviour following emotional reactivity. Enhanced awareness of thoughts, emotions and automatic behaviour can reduce psychological reactivity and thereby reduce the autonomic nervous system reactivity (psycho-neurological sympathetic over-activity). This program is called Mindfulness-Based Self -Managed Auto-Regulation Treatment (MB-SMART). The mindfulness program involves 2-hour sessions of education of physiological connectivity of mind and body and mindfulness practice weekly for 8 weeks. In addition to that, they also will do home practices of mindfulness, guided by a manual at the volunteers’ discretion. The sessions are conducted in small groups at the study center. The mindfulness teaching sessions are conducted by the principle researcher who has undertaken training in MBSR online and a few other mindfulness training courses including Mindfulness integrated cognitive behaviour therapy. She is a daily mindfulness practitioner.
It has two main components; Patient Education and Mindfulness Practices
Week 1.
Patient education.
a. How stress affects the body- Stress response and its consequences
b. What the science tells us about the mind-body connection.
c. Introduction to mindfulness
d. Patient’s role in disease management, address their concerns
e. Consequences of untreated disease

Week 2 to 8.
Mindfulness practices: (45 minutes)
a. Mindfulness of cognitive activities evoked by the information captured by each of our sensory organs (eye, ear, nose, tongue, skin) and followed by group discussion
b. Mindful awareness of thoughts and emotions followed by group discussions
c. Mindfulness with day to day activities followed by group discussion

Objectives of mindfulness sessions:
a. Participants will identify their own stressors that trigger stress-related behaviours
b. Participants will identify strategies to overcome stress-related behaviours.
c. Participants will review progress in avoiding stress-related behaviours followed by:
d. Learning and cultivating equanimity and objectivity.

Homework involves practicing the techniques learnt during previous weeks at least for 10 minutes in each technique. Participants are asked to journal their activities with their experience and feedback.
The control group will also be offered MB-SMART at the end of the trial if they are willing to try as a reward for participating in the study.

The stress response and the resilience of the cardiac autonomic activity are assessed before and after the intervention by monitoring heart rate variability using a device called Bodyguard2. This device is used in the fitness industry to monitor cardiovascular fitness. This device is certified to European standards (CE).

The signs and symptoms of COPD and hypertension will be monitored before and after the intervention.
Intervention code [1] 292711 0
Treatment: Other
Comparator / control treatment
Standard medical treatment of COPD and hypertension only.
Standard treatment means the medications for COPD and Hypertension.
Control group
Active

Outcomes
Primary outcome [1] 295968 0
Heart Rate Variability is the primary outcome. HR monitoring will be done during the first and last weekly sessions of mindfulness using the Bodygurad 2 monitor of Firstbeat Technologies
Timepoint [1] 295968 0
Base line : Primary outcome (HRV) will be assessed during the first weekly session.
Each participant in both groups will be asked to wear a monitor during pulmonary rehabilitation and those who participate in mindfulness will be monitored during mindfulness sessions each week.. At the end of the program: At HR will be monitored again for 24 to 48 hours at the the end of the 7th week and the monitors will be returned to the researcher on the 8th week. Heart rate monitoring will be repeated at 3, 6, 9 and 12 months follow up mindfulness sessions.
Primary outcome [2] 295970 0
Mindfulness level as assessed by Freiburg Mindfulness Questionnaire
Timepoint [2] 295970 0
At base line and post commencement of intervention at 8 weeks,3 months, 6 months and 12 months..
Secondary outcome [1] 317076 0
Psychological state by DASS21 questionnaire


Timepoint [1] 317076 0
At the recruitment and at the 8 weeks from the commencement of the study
Secondary outcome [2] 317077 0
Disease specific functionality and severity assessed by
the St. Georges Questionnaire
Modified Dyspnoea scale,
BODE scale and
Peak expiratory flow rate.
Timepoint [2] 317077 0
At base line and post commencement of intervention at 8 weeks, 6 months and 12 months follow up.
Secondary outcome [3] 317079 0
Functionality and quality of life assessed by WHODAS2.0 questionnaire
Timepoint [3] 317079 0
At base line and post commencement of intervention at 8 weeks, 6 months and 12 months.

Eligibility
Key inclusion criteria
1. Both male and female adults
2. In patients and outpatients at The Prince Charles Hospital with systolic blood pressure above 150 or diastolic blood pressure over 90
3. Diagnosed to have hypertension or COPD or both and on treatment
4. Those who are consented and committed to participate in the 8-week mindfulness training program
5. Have the willingness and ability to comply with assessment protocols
6. Be prepared to be contacted by the researcher to monitor and follow up mental and physical health status
7. Those who give consent to obtain the clinical history, examination and investigations from their medical practitioners
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those who are likely to change drug therapy during the study period.
2. Cognitive and Intellectual impairment
3. Those who do not have sufficient proficiency in the English language to communicate and comprehend study requirements.
4. Major psychiatric disorder
5. Pregnancy
6. Disability preventing from attending mindfulness classes
7. Those who are likely to have surgery during the study period.
8. Those who will be travelling or unavailable to attend all 8 classes of the mindfulness program

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)
Participants will be randomised by asking them to pick a number and a label to assign either to control or intervention group. at the recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Study sample is limited to 40 volunteers for the preliminary study and randomized into two groups of 20 in each, for control and intervention groups. The sample size will be calculated for subsequent trials based on the results of the pilot study.

Baseline characteristics will be compared by using an unpaired t-test (two-tailed). Behavioural questionnaires will be analysed using non-parametric Wilcoxon’s rank sum test. Outcomes following mindfulness interventions will be done using and paired t-test before and after mindfulness sessions within the intervention group and unpaired t-test between intervention and control arm. A p-value of less than 0.05 will be deemed significant. To observe whether there is a time effect to the biomarkers and baseline characteristics for the duration of follow up in the 6 and 12-month intervals between the control and intervention group, we will be using a repeated measures ANOVA taking a p value of less than 0.05 to demonstrate a significant group effect.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2018
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11624 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 10220 0
4509 - North Lakes
Recruitment postcode(s) [2] 23670 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 293449 0
Hospital
Name [1] 293449 0
The Prince Charles Hospital
Country [1] 293449 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital, Rode Road, Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 299804 0
None
Name [1] 299804 0
Address [1] 299804 0
Country [1] 299804 0
Secondary sponsor category [2] 299805 0
None
Name [2] 299805 0
Address [2] 299805 0
Country [2] 299805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294893 0
The Prince Charles Hospital Human Research Ethics Committee [EC00168]
Ethics committee address [1] 294893 0
TPCH, Rode Road, Chermside, QLD 4032
Ethics committee country [1] 294893 0
Australia
Date submitted for ethics approval [1] 294893 0
09/02/2018
Approval date [1] 294893 0
08/06/2018
Ethics approval number [1] 294893 0
HREC/18/QPCH/49

Summary
Brief summary
The aim of the study:
Overall Purpose of the research: is to explore scientific basis for preliminary and anecdotal evidence of psychosomatic nature and the pathophysiology of chronic physical diseases and to evaluate a psychological approach to treat physical disease.
The primary aim of this study is to assess the effectiveness of a Mindfulness-based program in improving cardiac autonomic nervous stress response in the patients with chronic obstructive pulmonary disease (COPD) and hypertension. The autonomic stress response is measured by measuring heart rate variability (HRV). Statistically significant increase in HRV after the Mindfulness practice compared to after the standard treatment only will be used to measure the effectiveness of the Mindfulness practice. Both the control and intervention will receive their standard treatment for COPD and hypertension. Only the intervention group will receive training in mindfulness practice.

Hypothesis: The hypothesis tested in this study is that Mindfulness Practice reduces autonomic stress response in moderate and severe COPD patients and in patients with hypertension.

Cohort: Adult male and female participants who are diagnosed to have moderate or severe chronic COPD and hypertension
Design:
This is a pilot study of a randomised control trial.
Phase 1:
We intend to recruit 40 moderate and severe COPD patients with uncontrolled hypertension. Half the group will be randomised to attend a weekly mindfulness training program for 8 weeks in addition to their standard treatment. The other half will act as the control group and will receive only the standard treatment.

Phase 2:
In phase 2, the same study will be expanded to include an additional number of participants based on findings of the pilot study and extended to explore other different non-communicable diseases associated with autonomic dysfunction.

The Mindfulness program (MB SMART)
Mindfulness program is designed with practices with a specific emphasis on increasing awareness of automatic behaviour following emotional reactivity using the body and emotional awareness. Enhanced awareness of thoughts, emotions and automatic behaviour can reduce psychological reactivity and thereby reduce the autonomic nervous system activity (psycho-neurological sympathetic over-activity). This program is called Mindfulness-Based Self -Managed Auto-Regulation Treatment (MB-SMART).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59906 0
Dr Amarasinghe Sophie Sepalika Jayamaha
Address 59906 0
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 59906 0
Australia
Phone 59906 0
_+61 7 3139 4000
Fax 59906 0
Email 59906 0
[email protected]
Contact person for public queries
Name 59907 0
Philip Masel
Address 59907 0
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 59907 0
Australia
Phone 59907 0
+61 7 31394000
Fax 59907 0
Email 59907 0
[email protected]
Contact person for scientific queries
Name 59908 0
Sophie Jayamaha
Address 59908 0
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 59908 0
Australia
Phone 59908 0
+61 488113435
Fax 59908 0
Email 59908 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.