Study of Potential Health Effects of a Relaxation-response-based Mental Health Promotion Course (RR-MHP) and the Possibilities for Its Applications in the Danish Public Health Sector
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in scores on Perceived Stress on Cohen's Perceived Stress Scale
研究概览
简要总结
The purpose of the study is to investigate health-promoting and stress-reducing psychological, physiological and hormonal effects of a 9-week meditation-based course in personal health and to examine potential baseline factors for any such effects. Thus, the investigators will investigate the course format (individual course or group-based course) as a potential factor the course outcome, and also individual background factors such as demographics and genetic variations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experience of stress, defined as a Cohen's perceived stress scale score >
- •Speaks and reads Danish fluently.
- •Ability to use the internet to complete questionnaires.
- •Participation in face-to-face study information meeting.
- •Signed agreement to the study conditions and informed consent form
排除标准
- •Other current treatment (psychological, medical or other) for stress, depression, anxiety, phobias, traumas or other psychological problems.
- •Other current treatment for bodily illnesses, such as pain, migraine, cancer.
- •More than one diagnose with psychiatric disease (e.g. anxiety, depression) within the past 3 years.
- •Body-Mass Index >
- •Major Depression Inventory score > 25 at inclusion interview.
- •Physical handicaps affecting life stress or quality of life chronically.
- •Drug use (> 50 times hash during the past two years; max 20 times harder drugs, max 2 times per month since the 18th birthday on average; no periods > 3 years where the use of drugs exceeded two times per month).
- •Alcohol use > 21 drinks/week for men, and > 14 drinks/week for women and AUDIT-scores (a scale of alcohol-related problems) >
- •Serious head trauma.
研究组 & 干预措施
Meditation training, group format
The course Relaxation Response-based Mental Health Promotion (publicly referred to as "Open and Calm") is given in group format.
The intervention entails 9 courses (1 per week of 2.5 hrs), a course book (120 pages), audio support (6 guided meditative practices), access to a webpage with additional information, and the possibility of two personal sessions with the intervention instructor (a certified psychologist).
干预措施: Relaxation Response-based Mental Health Promotion (RR-MHP) (Behavioral)
Meditation training, individual format
The course Relaxation Response-based Mental Health Promotion ("Open and Calm") is given by the same instructor as for group formats using precisely the same material and methods, but in about 6-9 (as to each persons' individual needs and preferences) face-to-face meetings.
干预措施: Relaxation Response-based Mental Health Promotion (RR-MHP) (Behavioral)
Wait-list control
This arm is an inactive wait-list control.
结局指标
主要结局
Change in scores on Perceived Stress on Cohen's Perceived Stress Scale
时间窗: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
The investigators expect a decrease in perceived stress of significantly larger magnitude in interventional groups than in waitlist controls across the three time points
Cortisol secretion as measured by the cortisol awakening response
时间窗: From baseline to post-treatment (after 9 weeks)
The investigators expect a significant reduction of cortisol secretion in intervention groups and larger than in wait-list controls. Specifically, the investigators analyze the Area Under Curve with respect to Ground (total cortisol output) after awakening. Cortisol was only collected for 2/3 data waves (N = 48) due to logistics. COMMENT: The investigators have two primary outcomes, but both are measures of stress levels. The investigators expect to see both hormonal and perceived stress improvements.
次要结局
- Change in Pittsburgh Sleep Quality Index (PSQI)(From baseline to post-treatment (9 weeks later) and to 3-month follow-up)
- Change in Quality of Life on the WHO-5 scale(From baseline to post-treatment (9 weeks later) and to 3-month follow-up)
- Change in Short-Form Health Survey-36(From baseline to post-treatment (9 weeks later) and to 3-month follow-up)
- Change in Major Depression Inventory(From baseline to post-treatment (9 weeks later) and to 3-month follow-up)
研究者
Steen G Hasselbalch
Professor, dr. med.
Rigshospitalet, Denmark