Interoceptive Intervention for Pulmonary Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: interoceptive group based intervention.
- Who it may be relevant to
- Registry conditions: Interoception, Pulmonary Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
Overview
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.
Interventions
- Other interoceptive group based intervention
8 week online group intervention aiming to improve interoception.
Primary outcome measures
- 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)]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United Kingdom · 1 center
- Golden Jubilee National Hospital — Glasgow
Identifiers
NCT: NCT06443580 · 24/MISC/01