Interoceptive Intervention for Pulmonary Hypertension

NCT ID: NCT06443580

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2025-10-18

Brief Summary

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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.

Detailed Description

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Conditions

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Interoception Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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group based interoceptive intervention

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

Group Type EXPERIMENTAL

interoceptive group based intervention

Intervention Type OTHER

8 week online group intervention aiming to improve interoception.

waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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interoceptive group based intervention

8 week online group intervention aiming to improve interoception.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Derick Moore

Trainee Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Golden Jubilee National Hospital

Glasgow, Clydebank, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Derick Moore

Role: CONTACT

+44 07805511803

Lynne Johnston, Doctorate Clinical Psychology

Role: CONTACT

Facility Contacts

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Joanne McGarry

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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24/MISC/01

Identifier Type: -

Identifier Source: org_study_id

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