The Relationship Between Social Anxiety and Anxious Thinking Styles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
研究概览
简要总结
This study aims to investigate whether reductions in negative interpretation biases, induced via an experimental manipulation (Cognitive Bias Modification for Interpretation; CBM-I), lead to reductions in symptoms of social anxiety amongst individuals experiencing high levels of social anxiety. The study further aims to investigate the relationship between multifaceted measures of interpretation bias, psychopathological symptoms, neurophysiological indices, behavioral indices of stress reactivity, and SAD symptoms.
To achieve these aims a sample of individuals experiencing high levels of social anxiety will be recruited. After completing multi-faceted measures of interpretation bias, including neurophysiological indices, participants will be randomized to complete an online one-week daily CBM-I or sham training control condition training schedule. Following the one week training, individuals will return to the lab to complete further multi-faceted measures of interpretation bias and social anxiety symptoms. One week after this (i.e. 2 weeks post-basline), participants will complete a final set of symptom and bias measures online.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants are blind as to whether they have been allocated to the active training condition or sham training condition.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provides informed consent
- •Sufficient German language skills to complete the experimental tasks and questionnaires
- •Aged between 18 and 65 years
- •Scoring ≥ 52 on the SPAI-G (Turner et al., 1989; Fydrich, 2016), indicating elevated levels of social anxiety
- •Lives within reasonable travelling distance of the research centre
排除标准
- •Current psychotherapeutic treatment or psychotherapeutic treatment completed within the last 6 months prior to study enrolment.
- •Current substance misuse or dependency (apart from Nicotine)
- •Acute suicidality or self-harm
- •Symptoms of a psychotic or bipolar disorder
- •Presence of a somatic condition that could systematically affect cortisol levels (in particular: Pregnancy and lactation, adrenal dysfunction, thyroid dysfunction, pituitary dysfunction)
- •Presence of a somatic condition that could systematically affect brain physiology (current or anamnestic neurological disorders, in particular: anamnestic traumatic brain injury, epilepsy, multiple sclerosis, brain tumors)
- •Presence of a somatic condition that could systematically affect peripheral physiological measures (in particular: cardiovascular diseases (e.g., cardiac arrhythmias, circulatory diseases [e.g., hypertension]))
- •Sensitivity or alteration of skin surface providing contraindication for EEG or periphysiological measures (in particular: baldness, dreadlocks, open wounds on the head or facial surface, skin conditions that cause particular sensitivity to gels and creams)
- •Intake of psychotropic medication that cannot be interrupted during study duration or change in psychotropic medication within the 8 weeks before starting the study (except: antidepressants in unaltered dosage)
- •Left handedness
结局指标
主要结局
Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
时间窗: Baseline, Follow-up (2 weeks post-baseline)
A 24-item self-report scale assessing social anxiety symptoms over the past 7 days (Consbruch, Stangier \& Heidenreich, 2016; Liebowitz, 1987). Possible scores range from 0 (minimum) to 144 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes). The primary outcome measure is change in score on the LSAS-SR from baseline to follow-up.
次要结局
- Anagram Task(Post-training (1 week post-baseline))
- Scenario Rating Task (SRT)(Baseline, Post-training (1 week post-baseline))
- Frontal Asymmetry(Baseline, Post-training (1 week post-baseline))
- Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)(Post-training (1 week post-baseline))
- Social Phobia and Anxiety Inventory, German version (SPAI-G)(Screening, Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline))
- Depression, Anxiety, and Stress Scale-21 (DASS)(Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline))
- Brief Fear of Negative Evaluation Scale (BFNE)(Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline))
- Encoding Recognition Task (ERT)(Baseline, After last intervention session (~6 days post-baseline), Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline))
- Salivary cortisol(Baseline, Post-training (1 week post-baseline))
- Salivary alpha-amylase(Baseline, Post-training (1 week post-baseline))
研究者
Marcella Woud
Junior Professor
Ruhr University of Bochum