Interoceptive Intervention for Pulmonary Hypertension

Официальное название

The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension

Обзор

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.

Вмешательства

• Другое interoceptive group based intervention
  8 week online group intervention aiming to improve interoception.

Первичные конечные точки

• Multidimensional Assessment of Interoceptive Awareness (MAIA-2) [Срок оценки: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]

Вторичные конечные точки (4)

• Feasibility and Acceptability Questionnaire [Срок оценки: at 8 weeks (during last intervention session)]
• The Generalised Anxiety Disorders Scale (GAD-7) [Срок оценки: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]
• Patient Health Questionnaire 9 (PHQ-9) [Срок оценки: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]
• emPHasis-10 [Срок оценки: baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 1 центр

• Golden Jubilee National Hospital — Glasgow

Идентификаторы

NCT: NCT06443580 · 24/MISC/01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗