Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Scores of Health Anxiety Questionnaire (HAQ)
研究概览
简要总结
This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy on treatment of somatic symptom disorder. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 and Health Anxiety Questionnaire are the primary endpoints.
详细描述
Somatic symptom disorder (SSD) is a psychiatric disorder featured with somatic distress and related psychological phenomena. In the past several years, our research team has investigated several aspects of SSD, including psychopathology, epidemiology, mechanism, and diagnostic biomarkers. But the aspect about treatment on SSD has not been comprehensively explored.
In literature, the treatment of SSD can be separated into physical and psychological approaches. The physical approach includes pharmacotherapy and magnetic/electrical neuromodulation. Among several types of psychotherapies, cognitive behavioral therapy (CBT) has the most evidence. Previous studies have disclosed SSD patients to have following cognitive or behavioral features: selective attention on somatic distress; memory bias on the severe health conditions; all-or-none cognition about health; organic attribution style; catastrophizing cognitive pattern about health; high motivation of concerning issues about health; inadequate reassurance-seeking behavior; the assumption about the connection between rest and somatic distress, etc.
Biofeedback therapy works by measuring several biological signals related with stress and relaxation (such as heart rate, skin conductance, electromyography, electroencephalography, and finger temperature); feedback of these signals to the subjects can help them more clearly understand the association between their behavior/cognition and relaxation. Biofeedback therapy has been extensively applied in the psychosomatic field.
This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 (PHQ-15) and Health Anxiety Questionnaire (HAQ) are the primary endpoints; the changes of other psychological and biological measurements are viewed as secondary endpoints.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with somatic symptom disorder (confirmed by psychiatrists)
排除标准
- •The age is younger than 20 or older than 70 years
- •Having psychotic symptoms or cognitive impairment
- •Having a potentially lethal illness
- •Cannot read the questionnaires by oneself
结局指标
主要结局
Scores of Health Anxiety Questionnaire (HAQ)
时间窗: Week 12 (comparing with the data in week 0)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Scores of Patient Health Questionnaire-15 (PHQ-15)
时间窗: Week 12 (comparing with the data in week 0)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
次要结局
- Heart rate variability(Week 12 (comparing with the data in week 0))
- Skin conductance(Week 12 (comparing with the data in week 0))
- Scores of Beck Depression Inventory-II (BDI-II)(Week 12 (comparing with the data in week 0))
- Scores of Beck Anxiety Inventory (BAI)(Week 12 (comparing with the data in week 0))
- Scores of Cognitions About Body and Health Questionnaire (CABAH)(Week 12 (comparing with the data in week 0))