NCT06443580Recruiting
Interoceptive Intervention for Pulmonary Hypertension
The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 24 May 2024
- Start date
- 17 Jun 2024
- Primary completion date
- 18 Oct 2025
- Lead sponsor
- Golden Jubilee National Hospital
- NCT number
- NCT06443580
What you commit to
- Study type: Interventional
- Planned participants: 32
- From 17 Jun 2024 to the primary completion date, 18 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Individuals with current thoughts of self-harm or suicide.
- Presenting with comorbid alcohol or substance misuse.
- Currently engaging in any additional psychological interventions at the time of the study.
Who the study is looking for
- Participants will be patients under the care of the Scottish Pulmonary Vascular Unit (SPVU) at the Golden Jubilee University National Hospital (GJUNH).
- Diagnosed with any type of PH.
- Adults over 18 years.
- Fluent in English.
- Able to commit to the duration of the research (expected to be three months from initial recruitment to the end of treatment).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.