Development and Pilot Randomised Controlled Trial of a Self-management Intervention to Help Individuals With Pulmonary Hypertension Live Better With Anxiety

Project Objectives The primary aim of this study is to develop a self-management intervention in collaboration with patient, public involvement, which will consist of experts by experience and experts by education. The intervention is aimed at helping individuals with PH to manage symptoms of anxiety.

A secondary aim of the project is to conduct a pilot randomised controlled trial investigating the aforementioned self-management intervention. More specifically, the project will explore acceptability and feasibility of the intervention itself and research methodology proposed to test its effectiveness. Qualitative and quantitative data will be collected for this purpose which will focus on: attrition rates; adherence to the intervention; participant's acceptability of the intervention and research methodology (i.e. eligibility, randomisation, emotional response, perceptions); outcome measures; recruitment and data collection procedures; and any adverse effects. Moreover, this project will investigate the preliminary efficacy of the intervention on a series of primary (anxiety symptoms - Generalised Anxiety Disorder -7) and secondary measures (depression - PHQ9); HRQoL- emphasis10); dyspnoea - dyspnoea12; perception of coping - self-mastery questionnaire; and cognitive and behavioural processes (Cognitive Behavioural Processes Questionnaire (CBPQ), so that effect sizes can be calculated and used to inform sample sizes of any future definitive trials.

Design The study will be a pilot randomised superiority trial. Participants will be randomised on a 1:1 basis to either one of two groups, (1) CBT informed self-management intervention to help manage anxiety in PH or a (2) controlled waiting-list condition. A control condition is required to control for any therapeutic gains associated with being involved in a trial. Participants will be asked to complete a series of measures pre-, post- and one month following completion of the intervention. As such, a 2 (cognitive-behavioural informed intervention or control waiting list) x 3 (pre-, post- and intervention) research design will be used. Participants or researchers will not be blinded to condition allocation (i.e. participants will be aware they may be randomised to a waiting list condition, and researchers may be contacting participants during the intervention for feedback on adherence and acceptability).

Procedure From the study advert promoted by the Pulmonary Hypertension Association, participants will be directed to a dedicated webpage for the proposed project.

From there, participants will be able to read the participant information sheet. Participants interested in talking part will be asked to click on a link that will take them to a series of questionnaire hosted by Qualtrics. Participants will first be asked to complete an eligibility form. Based on their responses, if participants are not eligible they will be informed immediately that they are unable to participate in the study. If participants are eligible, they will be asked to complete a consent form and a series of questionnaires (see below). All data entered on this page will be recorded, as it will help to inform feasibility of the inclusion/exclusion criteria (i.e. is the study excluding a large percentage of people based on a certain factor).