Functional Magnetic Resonance Imaging (fMRI) and Treatment of Social Phobia Over the Internet: Cognitive Behavioural Therapy (CBT) Versus Computerized Attention Training and the Possible Effect of Genetic Variation. (SOFIE-8)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Social Interaction Anxiety Scale (SIAS)
研究概览
简要总结
Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample.
Study hypothesis
How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes?
How is the genetic variations related to symptoms in social phobia (pre treatment)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
排除标准
- •Individuals with current depression and/or is suicide prone will be excluded from the study.
- •With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.
结局指标
主要结局
Social Interaction Anxiety Scale (SIAS)
时间窗: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Differences in recruited brain regions measured using regional cerebral blood flow
时间窗: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Blood-oxygen-level dependence (BOLD) signal change as measured with 3.0 T fMRI Change from baseline in BOLD signal expected between time frames.
Liebowitz Social Anxiety Scale self rated version (LSAS-SR)
时间窗: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Social Phobia Scale (SPS)
时间窗: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Measure social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Social Phobia Screening Questionnaire (SPSQ)
时间窗: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames.
次要结局
- Beck Anxiety Inventory (BAI)(pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63))
- Quality of Life Inventory (QOLI)(pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63))
- Variation in genes that have been associated with emotional processing(pretreatment (week 0).)
- Montgomery Åsberg Depression Rating Scale (MADRS-S)(pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63))
研究者
Per Carlbring, PhD
Professor
Umeå University