Interoceptive Intervention for Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443580
• Other study ID #: 24/MISC/01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: October 18, 2024

Study information

• Verified date: May 2024
• Source: Golden Jubilee National Hospital
• Contact: Derick Moore
• Phone: +44 07805511803
• Email: 2021489m[@]student.gla.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 18, 2024
• Est. primary completion date: October 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interoception
• Pulmonary Hypertension

Intervention

Other:
• interoceptive group based intervention
8 week online group intervention aiming to improve interoception.

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Glasgow	Clydebank

Sponsors (1)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility and Acceptability Questionnaire	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)
Secondary	The Generalised Anxiety Disorders Scale (GAD-7)	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)
Secondary	Patient Health Questionnaire 9 (PHQ-9)	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)
Secondary	emPHasis-10	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)