Effectiveness of Mind-Body Approaches for Three Distinct Medical Conditions: A Pragmatic Randomized Controlled Television Broadcast Experiment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- WHO-Five Well-being Index
研究概览
简要总结
Chronic diseases are currently the most prevalent and most costly health conditions world-wide, and morbidity is expected to increase over coming years. Factors such that increased life-expectancy and certain life style-related factors, such as smoking, high-fat diet and alcohol-consumption, are commonly associated with the increase in most of the common chronic diseases. However, more complex psychosocial factors such as depression, stress, work-related dynamics and thinking patterns are thought be associated with poor health status and impaired health related quality of life among patients with suffering from chronic physical conditions (i.e. a biopsychosocial approach). Therefore, psychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions.
The aim of this randomized trial is to evaluate the effectiveness of mind-body multidisciplinary rehabilitation on health-related quality of life, and disease specific endpoints in people with rheumatoid arthritis, psoriasis, or heart failure.
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
- •Rheumatoid arthritis:
- •RA according to the 1987 revised American College of Rheumatology criteria
- •Not selected on the basis of their level of activity.
- •The treatment of both the RA and any other medical condition have to be stable and constant for at least three months at the time of enrolment, and no future planned changes of therapy exist at the time of inclusion.
- •Oral corticosteroids, if used previously, will be allowed at a maximum prednisone dose with an equivalent of 10mg/day.
- •Diagnosed plaque psoriasis for 6 months or longer
- •Psoriasis medical condition have to be stable and constant for at least three months at the time of enrolment (i.e. no future planned changes of therapy exist at the time of inclusion).
排除标准
- •are other immune-mediated conditions requiring current systemic immunosuppressant treatment except psoriatic arthritis.
- •Heart Failure with reduced ejection fraction:
- •Symptomatic patients (NYHA class II or III, or NYHA class IV if CRT planned at enrolment) with systolic heart failure (left ventricular ejection fraction ≤40%) will be considered eligible for enrolment.
- •The qualifying left ventricular ejection fraction (measured on stable heart failure medication).
- •Exclusion Criteria:
- •Ability to participate
- •Psychopathology: Persons with severe mental illness are excluded.
- •Alcohol and/ or drug abuse
- •Impaired cognitive functions
研究组 & 干预措施
Active Intervention:
Mind-body intervention (incl. Relaxation Response Resiliency Program & the Open and Calm Program)
干预措施: Mind-Body Approaches for Medical Conditions (Behavioral)
No Intervention
No intervention (Study participants will receive routine clinical practice)
结局指标
主要结局
WHO-Five Well-being Index
时间窗: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
All participants. The WHO-5 consists of five statements. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
次要结局
- Hospital anxiety and depression scale (HADS)(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- SF36: Physical Component Summary (PCS)(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- Illness Perception Questionnaire(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- Mindful Attention Awareness Scale-5(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- High-sensitivity C-reactive protein (hs-CRP)(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- Cohen's Perceived Stress Scale(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- SF36: Mental Component Summary (MCS)(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- Pittsburgh sleep quality index(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
- Self-Compassion Scale(At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline)
研究者
Lina R. Khoury
Post-doctoral Researcher
University Hospital, Gentofte, Copenhagen