Facial Rehabilitation of Wellbeing in Depression: a Randomized Controled Trial of a Facial Physiotherapeutic Exercise Program in the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study investigates if a physiotherapeutic exercise program designed to relax facial muscles associated with the expression of negative emotions and to activate and strengthen facial muscles associated with the expression of positive emotions can reduce the symptoms of depression and improve wellbeing and quality of life in the affected patients.
详细描述
Activity of the facial musculature expresses emotions, but also generates proprioceptive signals to the emotional brain that maintain and reinforce the expressed emotions. This has been described by Charles Darwin and William James in the facial feedback hypothesis.
Studies have shown that interruption of facial feedback by the injection of botulinum toxin into the corrugator and procerus muscles, which express negative emotions like sadness, anger, and fear, can reduce the symptoms of depression.
In the present study we investigate, if similar effects can be achieved by a relaxing massage of these and other muscles that are associated with the expression of negative emotions and if strengthening exercises of muscles that express positive emotions, the zygomaticus and orbicularis oculi muscles, can contribute to the rehabilitation of positive emotionality in depression. After instruction by a physiotherapist, participants will practice the exercises daily for 15 minutes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate unipolar depression
- •Stable treatment for at least 6 weeks
排除标准
- •Organic mental disorders
- •Mental disorders due to psychoactive substance use
- •Schizophrenia and other psychotic disorders
- •Previous cosmetic procedures (botulinum toxin, fillers, lifting)
- •Facial palsy
- •Facial skin disorders
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 6 weeks
The Montgomery-Asberg Depression Rating Scale (MADRS) is an expert rating scale with 10 items for the measurement of the severity of depressive symptoms. Change in depression severity is measured as change in the total score of the scale (0-60 points).
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)(3, 9, 12 weeks)
- Change in Patient-Health-Questionnaire-9 (PHQ-9)(3, 6, 9, 12 weeks)
- Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D)(3, 6, 9, 12 weeks)