Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443580
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-24
Brief Title:
Interoceptive Intervention for Pulmonary Hypertension
Sponsor:
Golden Jubilee National Hospital
Organization:
Golden Jubilee National Hospital
Study Overview
Official Title:
The Relationship Between Interoception and Psychological Outcomes A Mind-Body Intervention in Patients With Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 individuals 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None