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临床试验/NCT01463137
NCT01463137已完成不适用

Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

Umeå University1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2011年10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 version

研究概览

简要总结

A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety 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 compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
  • •Comorbidity is allowed, but social phobia must be the primary diagnosis.

排除标准

  • •Below 18 years old.
  • •Individuals who are suicide prone will be excluded from the study.

研究组 & 干预措施

Positive bias training with words + pictures

Active Comparator

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word or face.

干预措施: Attention bias modification (Behavioral)

Negative bias training with words

Active Comparator

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word.

干预措施: Attention bias modification (Behavioral)

Negative bias training with words + pictures

Active Comparator

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.

干预措施: Attention bias modification (Behavioral)

Control training with words

Sham Comparator

Computerized, internet-based control training program. Participant is exposed to a pair of words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive word and the more negative word with equal frequency.

干预措施: Attention bias modification (Behavioral)

Control training with words + pictures

Sham Comparator

Computerized, internet-based control training program. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.

干预措施: Attention bias modification (Behavioral)

Positive bias training with words

Active Comparator

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word.

干预措施: Attention bias modification (Behavioral)

结局指标

主要结局

Change from baseline in Liebowitz Social Anxiety Scale self rated version

时间窗: pretreatment (week 0), post treatment (week 2), 4 month follow-up

Change from baseline in social anxiety symptoms expected between time frames.

次要结局

  • Change from baseline in Social Phobia Screening Questionnaire(Pretreatment (week 0), post treatment (week 2), 4 month follow-up)
  • Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)(Pretreatment (week 0), post treatment (week 2), 4 month follow-up)
  • Change from baseline in Social Interaction Anxiety Scale (SIAS)(Pretreatment (week 0), post treatment (week 2), 4 month follow-up)
  • Change from baseline in Quality of Life Inventory (QOLI)(Pretreatment (week 0), post treatment (week 2), 4 month follow-up)
  • Change from baseline in Social Phobia Scale (SPS)(Pretreatment (week 0), post treatment (week 2), 4 month follow-up)

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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