Title: PATHWAYS: Pulmonary ArTerial Hpertension - Workings with AnxietY and Stress. A randomised pilot study
Funder: Department of Health (England)

Abstract: Background Pulmonary Arterial Hypertension (PAH) is characterised by debilitating progressive symptoms of severe breathlessness, fatigue, blueness of the skin, coughing up blood, and declining functional ability. It is caused by raised pressures in the blood vessels between the heart and lungs as a result of increased flow due to congenital heart disease, or narrower vessels due to inflammatory mechanisms Treatment is currently palliative. Precise national prevalence data is unconfirmed but there are 5,538 known patients monitored in the UK in the national pulmonary hypertension service 1 . High levels of anxiety, depression, and particularly panic have been repeatedly reported in this population. These are associated with decreased quality of life and physical functioning, as well as an increase in reassurance sought about symptoms Mindfulness Based Stress Reduction (MBSR) has consistently been shown to benefit patients with other chronic and stressful conditions and may be suited to the treatment of people with PAH. The group-based course runs for a recommended 8-weeks, and includes education about stress and its effects on the body, becoming aware of unhelpful attitudes and thinking patterns, defining mindfulness and using it in everyday life, formal meditation techniques, and gentle stretching. Participants are given a resource booklet to accompany the course and asked to continue practising what they have learnt at home. The tailor-made course has an increased emphasis on recognising and managing symptoms of stress and focuses on working within personal limits, so gentle stretching exercises will not exclude patients with physical disabilities. Aims This pilot study aims to assess the feasibility and acceptability of conducting a future randomised controlled trial comparing MBSR with treatment as usual. The larger trial will aim to test the effectiveness and cost-effectiveness of an MBSR intervention in people with PAH aged over 16. Effectiveness will be assessed in terms of quality of life and physiological and psychological health. Plan of investigation Suitable patients will be sent an invitation letter and information about the study within three months of a future attendance at a routine hospital appointment. Written consent will be obtained from those wishing to participate and baseline measures of disease progression, quality of life, mindfulness, anxiety, depression, and use of NHS resources will be collected. Participants will then be randomised into two groups: intervention and control, stratified on geographical location. The control group will continue treatment as usual: attending scheduled appointments with care teams, taking prescribed medication, and accessing internal or external support, such as routine psychology or liaison nurse services. The intervention group will attend an 8-week MBSR course in addition to treatment as usual. The MBSR course will be tailored to meet the needs of PAH patients. Six and fifteen months after randomisation all participants will have outcomes re-assessed at their routine hospital appointments. Additionally, those in the intervention group will receive a questionnaire to assess their mindfulness practices. Qualitative interviews will elicit from patients their views on participating in the pilot study, of the intervention, and ways in which either may be improved for the future trial. The same will be applied to the control group. Summary of patient and NHS benefit Patients with chronic problems have increased anxiety and associated NHS costs, utilising 69% of health and social care resources 2. MBSR teaches self-management of stress and has demonstrated long-term benefits for patients with chronic conditions. If the future trial demonstrates the effectiveness of MBSR, it will help patients with PAH identify and manage symptoms related to increased stress, therefore increasing quality of life and reducing costs to the NHS. The intervention is anticipated to be potentially transferable to patients with other chronic cardiac conditions.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR