Interoceptive Intervention for Pulmonary Hypertension

Golden Jubilee National Hospital

Status: Enrolling

Conditions: Interoception; Pulmonary Hypertension

Treatments: Other: interoceptive group based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06443580

24/MISC/01

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

group based interoceptive intervention

Experimental group

Description:

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

Treatment:

Other: interoceptive group based intervention

waitlist

No Intervention group

Description:

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