A Parallel-Group Controlled Trial Examining the Efficacy of a Psychosomatic Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change from the baseline DS14 measure of Type D personality scores at time point 2.
研究概览
简要总结
This study examines the efficacy of a psychosensory intervention in relation to: Resilience, Type D personality, and physiological effects (on blood pressure, heart rate and salivary cortisol) in a group of people who have self-referred for the trauma resolution psychosensory therapy - Havening Techniques (HT).
详细描述
This study utilizes a single blind (researcher blind) comparison of the psychosensory therapy Havening Techniques (treatment) versus waiting list (no treatment). Participants will be assessed using resilience testing (CD-RISC), and Type D measure of personality (DS14). A subgroup of the treatment arm will be assessed for the biomarkers of blood pressure, heart rate and cortisol. This parallel-group controlled trial will examine the efficacy of Havening Techniques at 3 timepoints; baseline (Time point 1), twenty-four hours post (Time point 2) and one month later (Time point 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Coded-analysis group allocation and database - blind to allocation.
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
- •Able to provide informed consent.
- •Cognisant adults living in the United Kingdom.
- •Will have self-referred for Havening Techniques trauma therapy.
排除标准
- •Receiving any other therapeutic or pharmaceutical intervention in parallel.
- •For the psychobiological evaluation subgroup: a history of HIV, Tuberculosis or Hepatitis B due to laboratory regulations.
研究组 & 干预措施
Intervention Group (Treatment)
A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques).
干预措施: Psychosensory Therapy (Procedure)
Control Group (Waiting List)
Self-referral waiting list cohort (usual care).
结局指标
主要结局
Change from the baseline DS14 measure of Type D personality scores at time point 2.
时间窗: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Co-primary outcome measure: The DS14 measure of Type D personality is a 14-item questionnaire that uses a 5-point likert scale, each item weighted from 0 to 4. The DS14 incorporates the two 7-item subscales measuring the negative affect and social inhibition constituents of Type D personality (Denollet, 2005).
Change from the baseline Connor-Davidson Resilience Scale (CD-RISC) scores at time point 2.
时间窗: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Co-primary outcome measure: The Connor-Davidson Resilience Scale (CD-RISC) assesses resilience and constitutes a 25=item questionnaire scored on a 5-point likert scale (rated 0-4). This scale has been successfully applied to evaluate change in intervention studies targeted at resilience (Connor and Davidson, 2003).
次要结局
- Change in Systolic Blood Pressure at time point 3.(1 month post intervention (Time point 3))
- Change in Diastolic Blood Pressure from baseline to time point 2.(24 hours post intervention (Time point 2) versus pre-intervention (Time point 1))
- Change in Diastolic Blood Pressure at time point 3.(1 month post intervention (Time point 3))
- Change in Heart Rate from baseline to time point 2.(24 hours post intervention (Time point 2) versus pre-intervention (Time point 1))
- Change in Heart Rate at time point 3.(1 month post intervention (Time point 3))
- Change in Salivary Cortisol levels from baseline to time point 2.(24 hours post intervention (Time point 2) versus pre-intervention (Time point 1))
- Change in Salivary Cortisol Levels at time point 3.(1 month post intervention (Time point 3))
- Change in the DS14 measure of Type D personality score at time point 3.(1 month post intervention (Time point 3))
- Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.(1 month post intervention (Time point 3))
- Change in Systolic Blood Pressure from baseline to time point 2.(24 hours post intervention (Time point 2) versus pre-intervention (Time point 1))
研究者
Kirsty Hodgson
Principal Investigator - Research Lead
Cardiff Metropolitan University