Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group based interoceptive intervention | Experimental | an 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interoceptive group based intervention | Other | 8 week online group intervention aiming to improve interoception. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derick Moore | Contact | +44 07805511803 | 2021489m@student.gla.ac.uk | |
| Lynne Johnston, Doctorate Clinical Psychology | Contact | lynne.johnston4@gjnh.scot.nhs.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee National Hospital | Recruiting | Glasgow | Clydebank | g81 4dy | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2025 | |
| Reset | May 5, 2025 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2024 | May 29, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 30, 2024 | May 29, 2024 | ICF_001.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2025 | May 5, 2025 |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) |
| D002318 |
| Cardiovascular Diseases |