Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06443580

Interoceptive Intervention for 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Interoception Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Jubilee National Hospital

Glasgow, Clydebank, g81 4dy, United Kingdom

Location status: Recruiting

Location contact

Joanne McGarry

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interoceptive group based intervention

Other

8 week online group intervention aiming to improve interoception.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Derick Moore

CONTACT

[email protected]

+44 07805511803

Lynne Johnston, Doctorate Clinical Psychology

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Golden Jubilee National Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.