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临床试验/NCT01736631
NCT01736631已完成不适用

Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder: A Pilot Study

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013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
9
试验地点
2
主要终点
Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder

研究概览

简要总结

We are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia.

详细描述

Social phobia is a very prevalent anxiety disorder in people with bipolar disorder and is associated with adverse outcomes. Yet, social phobia is treatable by cognitive behavioural therapy or antidepressant medication. As antidepressants are often contra-indicated in people with bipolar disorder, cognitive behavioural therapy is the likely first choice treatment for social phobia in this population. However, people with bipolar disorder were excluded from previous clinical trials on treatment of social phobia. Our aim is to evaluate the acceptability and to provide a rough estimate of efficacy of cognitive behavioural therapy protocol for social phobia in people with bipolar disorder in a systematic case series. We will also prepare pilot data for evaluating the impact of treatment of comorbid social phobia on the long-term course of bipolar disorder.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of bipolar disorder I or II according to DSM-IV criteria and established in a structured interview
  • Bipolar disorder in remission for at least 12 weeks; defined as absence of depressive or manic episode according to DSM-IV criteria established in a structured interview and confirmed by Montgomery-Åsberg Depression Rating Scale score ≤ 12 and Young Mania Rating Scale score ≤ 7
  • Stable medication regime for at least 4 weeks prior to commencing CBT
  • Current diagnosis of social phobia according to DSM-IV criteria and established in a structured interview, including duration of social phobia of at least 6 months irrespective of age.
  • Social phobia is one of the primary complains (when bipolar disorder is in remission), justifying a therapeutic focus on this disorder.
  • Ability and willingness to consent to treatment
  • Ability to speak and write English

排除标准

  • Current substance use disorder
  • A previous adequate course of CBT for social phobia (at least 8 sessions) delivered by a trained therapist
  • Currently receiving any psychological therapy
  • Cognitive impairment that would preclude psychological therapy
  • Actively suicidal

结局指标

主要结局

Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder

时间窗: up to end of treatment (20 weeks)

Acceptability of cognitive behavioural therapy for comorbid social phobia in bipolar disorder will be assessed as proportion of offered sessions attended

Change on the Social Phobia Inventory (SPIN)

时间窗: Baseline and end of treatment (20 weeks)

次要结局

  • Mania symptom change(Baseline and end of treatment (20 weeks))
  • Change on the Liebowitz Social Anxiety Scale Scale Self-Report; Social Phobia Scale & Social Interaction Anxiety Scale; Social Phobia and Anxiety Inventory(Baseline and end of treatment (20 weeks))
  • Presence/absence of the social phobia diagnosis(Baseline and end of treatment (20 weeks))
  • Depression symptom change(Baseline and end of treatment (20 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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