Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice (SophoPrax)
试验速览
- 阶段
- 2 期
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Severity of Social Phobia Symptoms
研究概览
简要总结
The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. Private practitioners (N=36) will be randomized to one of two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without specific training). The investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. The following research questions can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of Social Phobia (SCID-I)
- •Liebowitz Social Anxiety Inventory Scale (LSAS) equal to or greater than 30
- •age between 18 and 70 years
排除标准
- •psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for Cluster C (SCID-II)
- •organic mental disorder
- •severe medical conditions
- •ongoing psychotherapy or initiation
- •psychopharmacological treatment
结局指标
主要结局
Severity of Social Phobia Symptoms
时间窗: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).
次要结局
- Diagnostic Status of Social Phobia(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of Symptoms of Social Anxiety (Performance Anxiety)(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions)(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of a Change in Safety Behaviors in Social Anxiety(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of Other Social Anxiety Symptoms(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of Symptoms of Depression(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of Emotion Regulation(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of the Quality of Life(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of the Times Missing from Work(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)
- Assessment of the General Level of Severity of Social Anxiety Symptoms(Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.)