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临床试验/NCT01119469
NCT01119469已完成3 期

Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof

Goethe University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)

研究概览

简要总结

This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis.

详细描述

Hypochondriasis is defined as a preoccupation with the fear of having a serious disease based on the person's misinterpretation of bodily symptoms (APA). For a long time hypochondriasis was seen as difficult to treat. Meanwhile effective psychological treatment for hypochondriasis exists. Psychotherapies using cognitive therapy (CT), cognitive behavioral therapy (CBT), exposure therapy (ET) or behavioral stress management approaches are effective in reducing symptoms of hypochondriasis. However, few studies compare different types of psychotherapy. In addition, in these studies numbers of participants were small, no differences between different treatments were found, and one third of the participants showed no satisfactory change. This study will compare the efficacy of CT and ET in a larger sample of 84 participants.

Participants in this randomized controlled trial (RCT) will first undergo baseline assessment. Then they will be randomly assigned to either CT, ET or a waiting list (WL), all conditions are for the duration of 12 weeks. CT includes psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention. ET includes change of safety behavior, exposition (in sensu and in vivo), and relapse prevention. Both treatment trials contain the identical number of sessions. Treatment response will be assessed at week 12 and additionally one and three years after treatment. Participants of the WL will be assigned to CT or ET after the waiting period.

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

入选标准

  • Meets DSM-IV criteria for hypochondriasis
  • German fluency and literacy
  • Informed consent

排除标准

  • Major medical illness expected to worsen significantly
  • Currently in psychotherapy
  • Suicidal tendency
  • Clinical diagnosis of alcohol or drug addiction, schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV

结局指标

主要结局

Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)

时间窗: 3 months

clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance

次要结局

  • Scale for the Assessment of Illness Behavior (SAIB)(3 months)
  • Cognitions About Body and Health Questionnaire (CABAH)(3 months)
  • Health-related quality of life (SF-12)(3 months)
  • Beck Anxiety Inventory (BAI)(3 months)
  • Brief Symptom Inventory (BSI)(3 months)
  • Illness Attitude Scales (IAS)(3 months)
  • Beck-Depression Inventory II (BDI-II)(3 months)

研究者

发起方
Goethe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Florian Weck

PhD

Goethe University

研究点 (2)

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