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临床试验/NCT04122846
NCT04122846已完成不适用

Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月30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
50
试验地点
1
主要终点
PHQ-15

研究概览

简要总结

The main purpose of the study is to conduct an initial feasibility evaluation of the new Internet-based EAET treatment manual. We will include 50 patients with somatic symptom disorder to take part of the treatment for nine weeks through the Internet. A within-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly. Feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. Linear mixed models will be used to investigate trajectories of change in symptoms and processes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Age over 18 years
  • A total score ≥10 on the PHQ-15
  • A diagnosis of SSD according to the DSM-5, i.e ≥1 of the 3 of: disproportionate thoughts about the somatic symtom, persistently high level of anxiety, or excessive time and energy devoted in regard to symptoms or health concerns
  • Symptom duration ≥6 months
  • Written statement from a medical professional that states that a medical evaluation has been conducted.

排除标准

  • Alcohol or substance addiction
  • A diagnosis of a psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
  • Other severe medical condition that might require other treatment
  • Ongoing psychological intervention or psychotherapy that may interfere with the psychological treatment
  • Ongoing medical treatment that may interfere with the psychological treatment

结局指标

主要结局

PHQ-15

时间窗: At study completion, after 4 months

Patient Health Questionnaire Physical Symptoms

次要结局

  • PHQ-9(At study completion, after 4 months)
  • GAD-7(At study completion, after 4 months)
  • SDS(At study completion, after 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Johansson

Associate professor

Karolinska Institutet

研究点 (1)

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