Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 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 an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces 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 or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).
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
- Single (Participant)
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
排除标准
- •Severe depression (and/or suicidal behavior)
- •Suffer from other severe psychiatric condition (e.g. psychosis)
- •Non-stable use of medication (3 months stable dosage)
- •Undergoing other, parallel psychological treatment
研究组 & 干预措施
CBM training program variant 1 + iCBT
Cognitive bias modification training program variant 1 combined with iCBT
干预措施: Internet-administered cognitive behavioral therapy (iCBT) (Behavioral)
CBM training program variant 1 + iCBT
Cognitive bias modification training program variant 1 combined with iCBT
干预措施: Cognitive bias modification training program variant 1 (Behavioral)
CBM training program variant 2 + iCBT
Cognitive bias modification training program variant 2 combined with iCBT
干预措施: Internet-administered cognitive behavioral therapy (iCBT) (Behavioral)
CBM training program variant 2 + iCBT
Cognitive bias modification training program variant 2 combined with iCBT
干预措施: Cognitive bias modification training program 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: Two weeks into treatment
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: 11 weeks
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: 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.
次要结局
- Change from baseline in Quality Of Life Inventory (QOLI)(2 weeks into treatment)
- Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(2 weeks into treatment)
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(2 weeks into treatment)
- Change from baseline in mini-SPIN(4 months)
- Change from baseline in Quality Of Life Inventory (QOLI)(11 weeks)
- Change from baseline in Quality Of Life Inventory (QOLI)(24 hours)
- Change from baseline in Quality Of Life Inventory (QOLI)(4 months)
- Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(24 hours)
- Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(11 weeks)
- Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale(4 months)
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(24 hours)
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(11 weeks)
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(4 months)
- Change from baseline in mini-SPIN(Daily, 1-15 days into treatment)
- Change from baseline in mini-SPIN(11 weeks)
研究者
Per Carlbring, PhD
Professor
Umeå University