跳至主要内容
临床试验/NCT04835103
NCT04835103已完成不适用

Build a Psychosomatic Research Clinic for Providing Comprehensive Managements to Somatoform Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Changes from baseline Health Anxiety Questionnaire (HAQ) score at 3 months and 6 months (for psychotherapy); changes from baseline HAQ score at 3, 6, 12, 24 months (for case management)

研究概览

简要总结

To investigate the effects of the two following interventions on somatoform patients:1. case management model2. psychotherapy, based on cognitive-behavioral therapy and biofeedback therapy

详细描述

Patients with presentations of somatic symptoms and associated psychological features are named as "somatoform disorders" in psychiatric field. Because the patients' concerns are somatic distress, they often seek help in non-psychiatric clinics. However, the symptoms are usually medically unexplained. This group of diagnoses can be managed from the psychiatric perspective, including medications and psychotherapies. However, many patients do not receive psychiatric management in current medical practice. The goal of this project is to establish an association named "psychosomatic center" for providing comprehensive evaluations and treatments to the somatoform patients. Besides the psychiatrist, a case manager, a clinical psychologist, and a research assistant will be included in this association for the purposes of connection, performing psychotherapy and examinations. After entering the psychosomatic clinic, the investigators will routinely perform diagnostic interview, measure psychological and physiological features, and arrange individualized treatment program. The investigators will follow the important psychological and biological indexes every 3-6 months for building a cohort. At the same time, the case manager will connect with non-psychiatric clinics for ensuring the patients physical problems to be managed. The investigators expect this project to enhance the quality of treatment on the patients, to reduce the excessive examinations for the frequent attenders, and to improve the emotional burden of medical staffs.

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
None

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 15 and 80 years old
  • Meet the diagnosis of DSM-5 somatic symptom disorder

排除标准

  • With psychotic symptoms (such as schizophrenia, bipolar disorder with psychotic symptoms) or cognitive impairment
  • Having potentially lethal physical diseases (such as cancer, coronary artery diseases, cerebrovascular diseases; because under this condition, high health anxiety is quite rational. Patients with common physical diseases can still enter this trial)
  • Unable to read or understand the questionnaires

结局指标

主要结局

Changes from baseline Health Anxiety Questionnaire (HAQ) score at 3 months and 6 months (for psychotherapy); changes from baseline HAQ score at 3, 6, 12, 24 months (for case management)

时间窗: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)

HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety).

Changes from baseline Patient Health Questionnaire-15 (PHQ-15) score at 3 months and 6 months (for psychotherapy); changes from baseline PHQ-15 score at 3, 6, 12, 24 months (for case management)

时间窗: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)

PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress).

次要结局

  • Penn State Worry Questionnaire (PSWQ)(3, 6, 12, 24 months)
  • Changes from baseline value of electromyogram(3, 6, 12, 24 months)
  • Scores of Beck Depression Inventory-II (BDI- II)(3, 6, 12, 24 months)
  • Scores of WHOQOL-BREF(3, 6, 12, 24 months)
  • Changes from baseline value of Respiratory sinus arrhythmia(3, 6, 12, 24 months)
  • Scores of Beck Anxiety Inventory (BAI)(3, 6, 12, 24 months)
  • Changes from baseline standard deviation of normal to normal RR intervals (SDNN)(3, 6, 12, 24 months)
  • Changes from baseline high-frequency power (HF)(3, 6, 12, 24 months)
  • Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF)(3, 6, 12, 24 months)
  • Changes from baseline value of skin conductance.(3, 6, 12, 24 months)
  • Changes from baseline value of Finger temperature.(3, 6, 12, 24 months)
  • Scores of Scale for the Assessment of Illness Behavior (SAIB)(3, 6, 12, 24 months)
  • Scores of Cognition About Body and Health Questionnaire (CABAH)(3, 6, 12, 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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