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临床试验/NCT01571089
NCT01571089已完成不适用

Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT) - An Alternative for Patients Who Previously Received Exposure-based Treatment for Anxiety Without Sustained Improvements.

Örebro County Council2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
2
主要终点
Change in anxiety (Clark, D. M., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., Flower, T., Davenport, C., Louis, B., 2003).

研究概览

简要总结

The main interest in this study is to investigate if it is possible to use strategies from Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive Behavioral Therapy (CBT) for patients with anxiety disorders. For the patients included in this study, previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Currently diagnosed with an anxiety disorder. To be included, the level of anxiety in a critical situation should be high and of a more acute type, unlike the lower more generalized anxiety in for example generalized anxiety disorder.
  • Previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).

排除标准

  • Severe depression.
  • Psychotic disorder.
  • A documented neuropsychiatric diagnosis.

结局指标

主要结局

Change in anxiety (Clark, D. M., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., Flower, T., Davenport, C., Louis, B., 2003).

时间窗: Every day during baseline phase, an expected average of 3 weeks. Everyday during treatment, an expected duration of 24 weeks. Everyday during 6 mo. follow-up, an expected average of 3 weeks.

A modified 6-item questionnaire measuring changes in different aspects of anxiety during the day. Originally developed to measure social anxiety.

次要结局

  • Positive Negative Affect Scale (PANAS), (Watson, Clark & Tellegan, 1988).(Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.)
  • Overall Anxiety Severity and Impairment Scale (OASIS), (Barlow, 2011).(Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.)
  • Overall Depression Severity and Impairment Scale (ODSIS), (Barlow, 2011).(Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.)
  • Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004).(Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.)
  • WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004).(Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.)
  • Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006).(Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.)
  • Structured Clinical Interview for DSM-IV-I (SCID-I), (First, Spitzer, Gibbon, & Williams, 2001).(Pre- and post treatment)

研究者

发起方
Örebro County Council
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sara Edlund

Doctoral student & Clinical psychologist

Örebro County Council

研究点 (2)

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