Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- At 6-month follow-up: M-CIDI (Composite International Diagnostic Interview, generalized anxiety disorder section)
研究概览
简要总结
The purpose of this study is to compare the effects of worry exposure with the effects of applied relaxation in patients with generalized anxiety disorder.
详细描述
Controlled treatment studies show that there is a lower efficacy of cognitive-behavioral treatment of generalized anxiety disorder (GAD) than in other anxiety disorders. The best effect sizes are found for applied relaxation (Öst), but there are only three treatment studies. Another, yet previously not tested in its pure form, approach is "worry-exposure", which aims at confronting the emotionally intensive imaginative contents of worries in GAD.
Fifty-two randomized patients with GAD as a primary diagnosis will be treated with one of the two treatments and will be compared with waiting-list patients. This treatment protocol contains 15 sessions (+/-2) and a 6 month and 12 month follow-up.
The comparisons in this study include: worry exposure versus applied relaxation versus a waiting control group.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Diagnosis of generalized anxiety disorder (according to impairment)
- •18-70 years of age
- •Informed consent
排除标准
- •Not able to understand and speak the German language
- •Acute, unstable and severe somatic disease (DSM-IV, Axis III)
- •History of schizophrenia or bipolar disorder
- •Other mental disorders requiring treatment
- •Substance dependence within the past 12 months preceding treatment
- •Personality disorders that interfere with treatment compliance
- •Participation in any other psychotherapeutic interventions
- •Use of anxiolytics (e.g. tranquilizer, hypnotics, neuroleptics; does not include stabile use of antidepressants)
结局指标
主要结局
At 6-month follow-up: M-CIDI (Composite International Diagnostic Interview, generalized anxiety disorder section)
At post-treatment: anxiety (Hamilton Anxiety Rating Scale, HARS), depression (Hamilton Depression Scale, HAM-D), trait-anxiety (State-Trait-Anxiety Inventory, STAI-T)
次要结局
- depression (Beck Depression Inventory, BDI)
- positive and negative affect (Positive and Negative Affect Schedule, PANAS)
- At post-treatment, 6 and 12 month follow-ups:
- general symptoms (Brief Symptom Inventory, BSI)
- meta-cognitions (Meta Cognitions Questionnaire)
- worry (Penn State Worry Questionnaire, PSWQ)
- interpersonal problems (Inventory of Interpersonal Problems - IIP)
- thought suppression (White Bear Suppression Inventory) tolerance for uncertainty (Ungewissheitstoleranzskala, UGTS)
- At post-treatment: behavior assessment tests