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临床试验/NCT01158430
NCT01158430已完成不适用

Treatment of Patients With Health Anxiety. A Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) Group Treatment Compared to a Waiting List

University of Aarhus2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
2
主要终点
Health anxiety measured by the Whiteley-7 index

研究概览

简要总结

The purpose of this study is to determine the effect of Acceptance and Commitment Therapy (ACT) in groups on functional level, emotional problems, and use of health care in patients with severe health anxiety in a randomized, controlled design.

详细描述

Health anxiety disorder or Hypochondriasis is a prevalent somatoform disorder, but a rarely used diagnosis in clinical practice despite studies having reported prevalence between 0.8-9.5% in primary care (Fink et al, 2004). As a consequence, the disorder is rarely treated.

The lack of valid, reliable, and generally accepted diagnostic criteria has been a major obstacle in clinical practice and Hypochondriasis studies, which causes problems particularly in distinguishing Hypochondriasis patients from other patients presenting with medically unexplained symptoms or functional symptoms.

In 2004, the investigators introduced a radically revised definition of Hypochondriasis. Hypochondriasis is viewed as a stigmatizing label, and the designation health anxiety has been suggested as replacement. This new diagnosis is empirically established. The essential feature of health anxiety is that the patients present with cognitive symptoms such as unfounded worrying about their health. In contrast to other somatoform disorders, the patients are not necessarily plagued by physical symptoms.

The new diagnostic criteria include the symptom 'obsessive rumination about illness' plus at least one of the symptoms 'worry or preoccupation with fears of harboring an illness or with bodily functions', 'suggestibility or autosuggestibility', 'an unrealistic fear of being infected or contaminated', 'an excessive fascination with medical information', or 'fear of taking prescribed medication'.

In the current study, health anxiety is diagnosed by use of newly introduced empirically established positive criteria for Health anxiety (Fink et al, 2004).

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Whiteley-7 score on 21,4 or more (scale 0-100 score points).
  • Severe health anxiety (diagnosed by SCAN interview).
  • Age 20-60 years
  • Patients of Scandinavian origin who understand, read, write and speak Danish.
  • No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
  • In case of a co morbid functional or other psychiatric disorder health anxiety must be the dominating problem.
  • Exclusion criteria:
  • Another severe psychiatric disorder or if the patient is suicidal.
  • Abuse of narcotics or alcohol and (non-prescribed) medicine.
  • No informed consent.

排除标准

  • 未提供

结局指标

主要结局

Health anxiety measured by the Whiteley-7 index

时间窗: 9 months (2nd follow-up)

次要结局

  • Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36)(9 months (2nd follow-up))
  • Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90)(9 months (2nd follow-up))
  • Social level of functioning measured with an alcohol dependency questionnaire (CAGE)(9 months (2nd follow-up))
  • Illness perception measured with Illness Perception Questionnaire (IPQ)(9 months (2nd follow-up))
  • Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)(9 months (2nd follow-up))
  • Health care use (National Patient Register & National Health Service Register (general practitioner (GP) contacts/consultations, specialists, physiotherapists, dentists, GPs' emergency service), The Danish Medicine Agency (medicine consumption)).(9 months (2nd follow-up))
  • Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)(9 months (2nd follow-up))
  • ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)(9 months (2nd follow-up))
  • ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II)(9 months (2nd follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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