InteroceptionNCT06443580
Interoceptive Intervention for Pulmonary Hypertension
A study testing interoceptive group based intervention in people with Interoception and Pulmonary Hypertension, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interoception, Pulmonary Hypertension
- What is being tested?
- interoceptive group based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2024to 18 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lynne Johnston, Doctorate Clinical Psychology contact
United Kingdom1 site, 1 recruiting
- Recruiting
Golden Jubilee National Hospital
Glasgow, Clydebank, g81 4dy
Joanne McGarry, joanne.mcgarry@gjnh.scot.nhs.uk
About this study
Official title: The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With 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.
Read more
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
- Being tested
- interoceptive group based intervention
- Keywords
- interoception, pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interoceptive group based interventionOther
8 week online group intervention aiming to improve interoception.
| Study group | Role | What they receive |
|---|---|---|
| group based interoceptive intervention | Experimental | an 8 week online group intervention where participants will learn skills to improve interoception and connect with their body. Receives: Other: interoceptive group based intervention |
| waitlist | No intervention | participants will wait until first group have completed intervention before commencing themselves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Secondary outcomes (4)
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.
Measured: at 8 weeks (during last intervention session)
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.
Measured: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
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.
Measured: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
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.
Measured: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Jun 2024
- Primary completion18 Oct 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InteroceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derick Moore, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443580
- Sponsor's protocol ID
- 24/MISC/01
- Status last verified
- Mar 2025
- First submitted
- 24 May 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06443580
- Acronym / sponsor ID
- 24/MISC/01
- Conditions
- Interoception, Pulmonary Hypertension
- Keywords
- interoception, pulmonary hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 18 Oct 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group based interoceptive intervention | Experimental | Other: interoceptive group based interventionan 8 week online group intervention where participants will learn skills to improve interoception and connect with their body. |
| waitlist | No intervention | –participants will wait until first group have completed intervention before commencing themselves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interoceptive group based intervention8 week online group intervention aiming to improve interoception. | Other | group based interoceptive intervention |
Primary outcome
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
4 secondary outcomes
Feasibility and Acceptability Questionnaire
Time frame: at 8 weeks (during last intervention session)
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)
Patient Health Questionnaire 9 (PHQ-9)
Time frame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
emPHasis-10
Time frame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynne Johnston, Doctorate Clinical Psychology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interoceptive group based intervention in people with Interoception and Pulmonary Hypertension, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derick Moore (+44 07805511803, 2021489m@student.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.