Trials / Recruiting
RecruitingNCT06443580
Interoceptive Intervention for Pulmonary Hypertension
The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Golden Jubilee National Hospital · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | interoceptive group based intervention | 8 week online group intervention aiming to improve interoception. |
Timeline
- Start date
- 2024-06-17
- Primary completion
- 2025-10-18
- Completion
- 2025-10-18
- First posted
- 2024-06-05
- Last updated
- 2025-03-11
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06443580. Inclusion in this directory is not an endorsement.