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临床试验/NCT01577303
NCT01577303已完成不适用

Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification

Umeå University1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

研究概览

简要总结

The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a population diagnosed with this disorder.

详细描述

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Written informed consent provided
  • •Diagnosed social phobia (according to DSM-IV criteria)
  • •Access to computer with internet connection, and printer

排除标准

  • •Severe depression (and/or suicidal behavior)
  • •Addiction and/or abuse
  • •Suffer from other severe psychiatric condition (e.g. psychosis)
  • •Non-stable use of medication
  • •Undergoing other, parallel psychological treatment

研究组 & 干预措施

CBM training program variant 1

Experimental

Attention training towards positive cues using words as stimuli

干预措施: Cognitive bias modification training program variant 1 (Behavioral)

CBM training program variant 2

Experimental

Attention training towards positive cues using words and faces as stimuli

干预措施: Cognitive bias modification training program variant 2 (Behavioral)

CBM training program variant 3

Experimental

Attention training towards negative using words as stimuli

干预措施: CBM training program variant 3 (Behavioral)

CBM training program variant 4

Experimental

Attention training towards negative using words and faces

干预措施: CBM training program variant 4 (Behavioral)

Control training variant 1

Experimental

Control training condition using words as stimuli

干预措施: Control training variant 1 (Behavioral)

Control training variant 2

Experimental

Control training condition using words and faces as stimuli

干预措施: Control training variant 2 (Behavioral)

结局指标

主要结局

Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

时间窗: 4 months

The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

时间窗: 24 hours

The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

时间窗: 14 days

The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

次要结局

  • Change from baseline in Quality Of Life Inventory (QOLI)(4 months)
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(4 months)
  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(4 months)
  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(14 days)
  • Change from baseline in Quality Of Life Inventory (QOLI)(24 hours)
  • Change from baseline in Quality Of Life Inventory (QOLI)(14 days)
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(24 hours)
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(14 days)
  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Carlbring, PhD

Professor

Umeå University

研究点 (1)

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