None listed
Conditions
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).
Interventions
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 practice
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.
Sponsors
The Prince Charles Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed