The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
时间窗: 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
次要结局
- The Generalised Anxiety Disorders Scale (GAD-7)(baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session))
- Feasibility and Acceptability Questionnaire(at 8 weeks (during last intervention session))
- emPHasis-10(baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session))
- Patient Health Questionnaire 9 (PHQ-9)(baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session))
研究者
Derick Moore
Trainee Clinical Psychologist
Golden Jubilee National Hospital