Interoceptive Intervention for Pulmonary Hypertension

NCT06443580 | Recruiting DMC

• 1 other identifier: 24/MISC/01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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

Interoception; Pulmonary Hypertension

Keywords

interoception; pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

  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 Outcomes (4)

• Feasibility and Acceptability Questionnaire

  at 8 weeks (during last intervention session)

• The Generalised Anxiety Disorders Scale (GAD-7)

  baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

• Patient Health Questionnaire 9 (PHQ-9)

  baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

• emPHasis-10

  baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

Study Arms (2)

group based interoceptive intervention

EXPERIMENTAL

an 8 week online group intervention where participants will learn skills to improve interoception and connect with their body.

Other: interoceptive group based intervention

waitlist

NO INTERVENTION

participants will wait until first group have completed intervention before commencing themselves

Interventions

interoceptive group based intervention OTHER

8 week online group intervention aiming to improve interoception.

group based interoceptive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, Clydebank, g81 4dy, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Derick Moore

CONTACT

+44 07805511803; 2021489m@student.gla.ac.uk

Lynne Johnston, Doctorate Clinical Psychology

CONTACT

lynne.johnston4@gjnh.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 5, 2024
• Study Start: June 17, 2024
• Primary Completion: October 18, 2025
• Study Completion: October 18, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

GB (1)