Clinical Trial

Interoceptive Intervention for Pulmonary Hypertension

Recruiting
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Record status
This record was last updated March 11, 2025 (before its estimated October 18, 2025 completion). Its status may not reflect the trial's current state.
Summary
Background Pulmonary hypertension is a rare and incurable condition characterised by fatigue and breathlessness. The effects of pulmonary hypertension has a significant impact on an individual's emotional wellbeing and there are currently no established psychological interventions to improve this. Interoception is defined as the ability to perceive the internal state of the body and emerging research suggests that interventions to improve interoception can improve well-being. Aims The project aims to develop an interoceptive based intervention for those with pulmonary hypertension and examine the feasibility and acceptability of this. Additional aims are to explore the preliminary results of the intervention. Methods A randomised control feasibility trial will be used. Thirty-two participants will be included. Participants will be patients within the Scottish Pulmonary Vascular Unit diagnosed with pulmonary hypertension and randomly assigned to either the intervention or control (waitlist) group. The intervention will be an eight-session online group and participants will complete measures for interoception, anxiety, depression, health related quality of life, as well as a feasibility and acceptability questionnaire. Quantitative analysis will include descriptive statistics and T-tests (including non-parametric versions) to analyse the feasibility and gain a preliminary understanding of the intervention. Practical Applications It is hoped that the findings will identify a sample size for a larger trial whilst also informing future clinical practice. This project will be written up for a suitable journal and will be presented at an appropriate conference.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-29; most recent amendment 2025-03-10.
Status change: Not Yet Recruiting → Recruiting 2024-09-23
Trial Details
NCT Number NCT06443580
Lead Sponsor Golden Jubilee National Hospital
Conditions Interoception, Pulmonary Hypertension
Enrollment 32 participants
Start Date 2024-06-17
Primary Completion 2025-10-18 (estimated)
Study Completion 2025-10-18 (estimated)
Updated on ClinicalTrials.gov 2025-03-11