Interoceptive Intervention for Pulmonary Hypertension

March 10, 2025 updated by: Derick Moore, Golden Jubilee National Hospital

The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group based interoceptive intervention
an 8 week online group intervention where participants will learn skills to improve interoception and connect with their body.
Other: interoceptive group based intervention
8 week online group intervention aiming to improve interoception.
No Intervention: waitlist
participants will wait until first group have completed intervention before commencing themselves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Time Frame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
This self-report measure includes 32-items split into eight subscales of interoception. Participants rate each item on a six-point Likert scale, with higher scores indicating higher interoception. This measure has been shown to be reliable, including for those with a long-term health condition
baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability Questionnaire
Time Frame: at 8 weeks (during last intervention session)
A questionnaire will be developed by the lead researcher to collect information regarding feasibility and acceptability. This will be completed at the end of the intervention. Participants will be asked about different aspects of the intervention, their engagement in the study and their perceptions of change regarding managing their PH. Questionnaires will be structured statements and participants will be asked to rate their response on a five-point Likert scale. There will also be a comment section at the end of the questionnaire for participants to discuss any additional thoughts they may have.
at 8 weeks (during last intervention session)
The Generalised Anxiety Disorders Scale (GAD-7)
Time Frame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
is a self-report measure that has been widely used to assess generalised anxiety within primary care settings and has shown good reliability and construct validity (Johnson et al., 2019). It consists of seven items measuring generalised anxiety and is scored on a four-point Likert scale. Scores range from 0-21 with higher scores indicating greater anxiety severity.
baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
a self-report measure consisting of nine items measuring depressive symptoms within primary care settings and has shown to have good psychometric properties (Johnson et al., 2019). Items are scored on a four-point Likert scale with scores ranging from 0-27, with higher scores indicating greater depression severity.
baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
emPHasis-10
Time Frame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
a 10 item self-report questionnaire measuring HRQoL that has been specifically designed for those with PH and has been used in previous PH research (Rawling et al., 2022; Odevoglu et al., 2018). Items are scored on a six-point Likert scale with scores ranging from 0-50 with higher scores indicating lower levels of HRQoL.
baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

October 18, 2025

Study Completion (Estimated)

October 18, 2025

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24/MISC/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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