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临床试验/NCT06443580
NCT06443580
招募中
不适用

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

Golden Jubilee National Hospital1 个研究点 分布在 1 个国家目标入组 32 人2024年6月17日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Interoception
发起方
Golden Jubilee National Hospital
入组人数
32
试验地点
1
主要终点
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
状态
招募中
最后更新
去年

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.

注册库
clinicaltrials.gov
开始日期
2024年6月17日
结束日期
2025年10月18日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Derick Moore

Trainee Clinical Psychologist

Golden Jubilee National Hospital

入排标准

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))

研究点 (1)

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