Clinical trial NCT06443580: Interoceptive Intervention for Pulmonary Hypertension
Official title: The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interoception
Pulmonary Hypertension
Keywords: interoception
pulmonary hypertension
Lead sponsor: Golden Jubilee National Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


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.

Primary outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
timeFrame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Secondary outcomes:
measure: Feasibility and Acceptability Questionnaire
timeFrame: at 8 weeks (during last intervention session)
measure: The Generalised Anxiety Disorders Scale (GAD-7)
timeFrame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
measure: emPHasis-10
timeFrame: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Clydebank
Study officials:
References: