Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility of study recruitment
研究概览
简要总结
Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol.
详细描述
Introduction
Mental health services are stretched in the UK and in need of support. One approach that could improve mental health symptoms is osteopathy. Research suggests that osteopathy influences psychophysiological factors, which could lead to improvements in mental health. The first objective of this protocol is to investigate the feasibility and acceptability of four osteopathic interventions. A secondary aim is to evaluate the interventions' effectiveness in improving psychophysiological and mental health outcomes.
Methods and analysis: This study will be an explanatory mixed-methods design. Participants will be 30 adults who have mild to moderate mental health symptoms and not experiencing any issues with pain. The feasibility and acceptability of the interventions will be the first primary outcome. Secondary outcomes will be physiological measures including heart rate variability (HRV), interoceptive accuracy (IAc) and blood pressure (BP). Psychological outcomes will also be measured by standardised questionnaires. These are being collected pre-and post-intervention. Additional outcomes will include recruitment rates and any adverse events that occur during the study. Participants will be randomised to one of four interventions. These are: high-velocity and articulation techniques (HVAT), soft-tissue massage (STM), craniosacral therapy (CST), and a combination of these three approaches. Participants will be interviewed about their experiences of the study and interventions to aid in assessing the feasibility and acceptability.
Discussion: This study will assess the feasibility and acceptability of conducting osteopathic interventions for improving mental health outcomes. These results from this will help to inform the running of a future randomised controlled trial. The study will also be producing original data which could provide preliminary evidence whether osteopathic approaches are of benefit to individual's mental health, even if they are pain-free.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Mild to moderate mental health symptoms as measured by DASS
- •Ability to read/write English.
排除标准
- •No mental health symptoms or severe mental health symptoms (as measured by DASS)
- •acute or chronic pain
结局指标
主要结局
Feasibility of study recruitment
时间窗: 3 months
Recruitment rate
Feasibility of assessing physiological measurements
时间窗: 3 months
Time to take physiological measurements
Feasibility of time to complete study
时间窗: 3 months
Time to complete questionnaires
Feasibility of study data collection
时间窗: 3 months
Missing data reported
Acceptability of intervention to participants
时间窗: 3 months
Feedback from participants in qualitative interviews
Acceptability of intervention and risk factors
时间窗: 3 months
Adverse events reported
次要结局
- Blood pressure(3 months)
- Self as context scale (SACS)(3 months)
- Interoceptive accuracy(3 months)
- Depression Anxiety and Stress Scale (DASS)(3 months)
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(3 months)
- Positive and negative affect schedule (PANAS)(3 months)
- Acceptance and action questionnaire (AAQ)(3 months)
- Heart rate variability(3 months)
研究者
Darren Edwards
Principle Investigator
Swansea University