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临床试验/NCT01574014
NCT01574014终止2 期

Glucocorticoid Treatment for Social Phobia

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
66
试验地点
1
主要终点
Change from baseline in spider phobia symptoms / social phobia symptoms

研究概览

简要总结

Social phobia is the third most common psychiatric disorder besides depression and alcoholism. Several studies have demonstrated the efficacy of cognitive-behavioral therapy in the treatment of social phobia. Nevertheless, there is no effect in a third of the people at the existing treatment methods. Pharmacological therapies have similar effects, but there is a high rate of relapse after discontinuation of medication.

Social phobia is characterized by fear of performance or interaction situations. The strong fear of negative evaluation by others is usually accompanied by a marked avoidance behavior and increased physical symptoms such as blushing, sweating, palpitations, or tremors. The confrontation with a phobic stimulus leads to a retrieval of stimulus-associated aversive memories, resulting in an immediate anxiety response. Several studies had already shown that elevated glucocorticoids impair retrieval of declarative memory contents in healthy subjects. The investigators demonstrated an anxiety-reducing effect after the administration of cortisone before the confrontation with a phobic stimulus in patients with social and spider phobia.

详细描述

Background

Anxiety disorders have major public health significance and social phobia ranks as the third most common mental health disorder after depression and alcoholism. Even though cognitive-behavioral therapy (CBT) is the most effective non-pharmacological approach to the treatment of social phobia, more than one third of the patients do not respond to treatment, or achieve only partial remission of symptoms. Pharmacotherapy (e.g., SSRIs, benzodiazepines) has been shown to be effective in the acute treatment of social phobia, however, with high rates of relapse when medication is discontinued. In addition, the combination of CBT and medication does not seem to be more beneficial than CBT alone. Consequently, the development of innovative psychobiological approaches combining effective psychotherapy methods with synergizing substance administration is a primary challenge in interdisciplinary research on treatment of social phobia.

In a recent study the investigators found evidence that a pharmacological elevation of glucocorticoid levels reduces fear in patients with social phobia and spider phobia exposed to a phobic stimulus. Furthermore, the investigators have shown that repeated administration of glucocorticoids before exposure to a phobic stimulus leads to an extinction of phobic fear. Also the low-dose administration of cortisone over a month in patients with post-traumatic stress disorder reduces cardinal of symptoms the disorder. Based on these findings, glucocorticoid treatment, in combination with exposure therapy, may help to reduce fear and promote extinction of phobic fear.

In an interdisciplinary research project involving psychology, behavioral pharmacology psychiatry, genetics and neuroimaging the investigators propose to investigate the therapeutic efficacy of combining an exposure-based cognitive-behavioral group therapy (CBGT) with hydrocortisone treatment. The investigators hypothesize that hydrocortisone exerts both acute beneficial effects by reducing fear during exposure, and long-term beneficial effects by facilitating the extinction of phobic fear. Furthermore, the investigators hypothesize differential treatment responses depending on genetic variations in glucocorticoid-related genes (substudy 1). These hypotheses will be tested in a clinical study with 100 patients with mainly speech anxiety who fulfill DSM-IV criteria for a diagnosis of social phobia and 60 patients with spider phobia.

This is the first study aimed at determining the therapeutic efficacy of combining hydrocortisone administration and a short-term exposure-based cognitive-behavioral group therapy for the treatment of social phobic patients with specific speech anxiety and patients with spider phobia. Considering the large number of patients suffering from social phobia, the suggested interdisciplinary project will have important clinical implications for the development of a more effective therapy.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age (20-55)
  • Spider Phobia
  • Right Handed
  • Social Phobia

排除标准

  • Other Psychiatric Disorder / Comorbidities
  • Smoking more than 15 cigarettes per day
  • Medication
  • Contraceptives
  • Physical illness
  • Neurological disease
  • Drug abuse

研究组 & 干预措施

1: CBGT & Hydrocortisone

Active Comparator

干预措施: CBGT (Behavioral)

1: CBGT & Hydrocortisone

Active Comparator

干预措施: Hydrocortisone (Drug)

2: CBGT & Placebo

Placebo Comparator

干预措施: CBGT (Behavioral)

2: CBGT & Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Change from baseline in spider phobia symptoms / social phobia symptoms

时间窗: at follow-up visit, expected to be after 3 months

measured by various standardized questionnaires

次要结局

  • Change from baseline in state and trait anxiety(1-3 weeks before treatment, 4 weeks after treatment, 3 months after treatment)
  • Change from baseline in personality traits(1-3 weeks before treatment)
  • Change from baseline in amygdala activation(1-3 weeks before treatment, 4 weeks after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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