Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design: What Works Best and How Does it Work (OPTIMIZE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 2
- 主要终点
- Change on social anxiety symptoms at post-treatment
研究概览
简要总结
Social Anxiety Disorder (SAD) is characterized by a marked fear of negative evaluation in social situations. It is the third most common psychiatric disorder and highly disabling (American Psychiatric Association, 2000). Although effective treatments such as cognitive-behavioral therapy (CBT) are available, most individuals suffering from SAD do not seek and eventually find help, and even in the best available treatments, remission rates are below 50%. The overall aim of the project is to better understand and improve the efficacy of Internet-based CBT (ICBT) that has shown to be efficacious in many trials and that provide broad and low-threshold access to empirically supported treatments. Specifically the objectives of the study are:
- to investigate the active ingredients of ICBT for SAD by testing the main effects and interactions for the four main treatment components (i.e., psychoeducation, cognitive restructuring, attention training, and exposure);
- to investigate the effects of each treatment component on hypothesized change mechanisms, and to explore whether and which change mechanisms mediate the effect of the treatment components on symptom reduction.
- to investigate whether the specific mechanisms mediate the effect of the treatment components on primary and secondary outcomes.
详细描述
Social Anxiety Disorder (SAD) is characterized by a marked fear of negative evaluation in social situations. It is the third most common psychiatric disorder and highly disabling. Although effective treatments such as cognitive-behavioral therapy (CBT) are available, most individuals suffering from SAD do not seek and eventually find help, and even in the best available treatments, remission rates are below 50%. The overall aim of the project is to improve the efficacy of Internet-based CBT (ICBT) that has shown to be efficacious in many trials and that provide broad and low-threshold access to empirically supported treatments. Specifically, the objectives of the study are:
- to investigate the active ingredients of ICBT for SAD by testing the main effects and interactions for the four main treatment components (i.e., psychoeducation, cognitive restructuring, attention training, and exposure);
- to investigate the effects of each treatment component on hypothesized change mechanisms (change of the knowledge of SAD, change on negative social cognitions, changes on self-focused attention, changes on social avoidance and use of safety behaviors), and to explore whether and which change mechanisms mediate the effect of the treatment components on symptom reduction.
- to investigate whether the specific mechanisms mediate the effect of the treatment components on primary and secondary outcomes.
The study is a single-center, factorial trial with four experimental factors (treatment components, i.e., psychoeducation, cognitive restructuring, attention training, and exposure) each evaluated at two levels (presence vs. absence) resulting in 16 conditions.
Recruitment: Participants will be recruited using reports in newspapers, through internet forums, social media (e.g., Facebook), and via our website (https://www.online-therapy.ch/) in German-speaking countries.
Sampling: After checking the inclusion criteria, participants will be randomized with equal probability to one of the 16 conditions. The random allocation will be unknown to the investigators. In order to keep the sample sizes of the 16 conditions similar, the allocation list will be made using randomly permuted blocks. A total of 464 participants with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of SAD will be included, with 29 patients being assigned to each of the 16 conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •read the study information and sign informed consent;
- •are 18 years or older;
- •have access to the Internet, to a smartphone, PC or tablet;
- •have sufficient knowledge of German;
- •exceed predefined cut-off scores on one of the social anxiety measures (22 points on the Social Phobia Scale or 33 points on the Social Interaction Anxiety Scale; SPS & SIAS);
- •fulfil the diagnostic criteria of SAD according to the diagnostic telephone interview (the presence of other disorders does not result in exclusion if SAD is the primary diagnosis)
- •in the case of taking psychiatric medication, the treatment is stabilized (over one month)
排除标准
- •they score 2 or higher on the suicide item of the PHQ-9 (Spitzer, 1999) or with active suicidal plans in the diagnostic telephone interview.
- •they have other comorbid psychiatric conditions that might be the main focus of clinical attention (e.g., psychotic symptoms, bipolar disorder, or other severe disorder)
- •they undergo another psychological treatment at the beginning of the study.
结局指标
主要结局
Change on social anxiety symptoms at post-treatment
时间窗: Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline)
Composite endpoint. Social anxiety symptoms are measured as the combined score of the Social Phobia Scale and the Social Interaction Anxiety Scale (SPS \& SIAS; Mattick \& Clarke, 1998). These instruments are complementary and used as one single measurement. They assess the fear of being judged by others during daily activities (SPS) and more general fears in social interaction (SIAS). The combined scale consists of 40 items and scores range from 0 (no social anxiety symptoms) to 160 (severe social anxiety symptoms).
次要结局
- Change on social anxiety symptoms at follow-up(Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline))
- Change on the severity of depressive symptoms(Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline))
- Change on quality of life(Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline))
- Level of satisfaction with the treatment(Post-treatment (8 weeks after baseline))
- Change on the diagnosis of social anxiety disorder(Baseline, Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline))
- Change on the severity of general anxiety symptoms(Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline))
- Negative effects of the treatment(Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline))