Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change of Liebowitz Social Anxiety Scale (LSAS-SR)
研究概览
简要总结
Goals of the study:
Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the time, did not include anxiety disorders. According to the 2007 joint methods paper of the WBP and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be three randomized-controlled trials (RCT) for anxiety disorders. These studies are available now but lack explicit details about the clinical significance of the reductions they show in social anxiety symptoms. This project is funded by the German Association for Systemic Therapy, Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie, Beratung und Familientherapie: DGSF).
Study design:
The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders (SAD) in 32 patients.
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
- None
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
- 否
入选标准
- •Social Anxiety Disorder (SKID: ICD-Diagnosis: F40.1, Liebowitz Social Anxiety Scale > 30);
- •Agreement to participate in the study and to be randomized into the two treatment groups
排除标准
- •Acute drug or alcohol intoxication or dependency
- •Anorexia with BMI < 14
- •Psychotic disorder
- •Severe physical diseases
研究组 & 干预措施
Systemic Therapy
Systemic Therapy deals with the experience in private social systems (e.g. couples. Family, friends) and organizational systems (e.g. work teams), their appraisals and the attitude of the members towards each other within the system. It is analyzed how these systems can lead to the development and maintenance of psychological disorders.
干预措施: Systemic Therapy for Social Anxiety Disorder (Behavioral)
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy deals with individual behavior as well as individual attitude, thoughts, appraisals and beliefs, which can have an influence on the development and maintenance of psychological disorders.
干预措施: Cognitive Behavioral Therapy for Social Anxiety Disorder (Behavioral)
结局指标
主要结局
Change of Liebowitz Social Anxiety Scale (LSAS-SR)
时间窗: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Social Anxiety will be assessed using the Liebowitz Social Anxiety Scale (LSAS-SR) in its German version. The LSAS-SR is a brief 24-item self report instrument with 13 items relating to performance anxiety and 11 concerning social situations. Its purpose is to assess the range of social interaction and performance situations feared and the degree of avoidance by a patient in order to assist in the diagnosis of social anxiety disorder, 24 items, German version
Change of Social Interaction Anxiety Scale (SIAS)
时间窗: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Measure of social interaction anxiety, 20 items, German version
Change of Social Phobia Scale (SPS)
时间窗: Baseline, 8th,15th and 20th hour of therapy, end of treatment; 6, 9 and 12 months after randomization
Measure of anxiety while being observed by others, 20 items, German version
次要结局
- Change of Adjustment to Symptomatology Scale (ASS)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Evaluation of Social Systems (EVOS)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Experience in Social Systems (EXIS)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Beck Depression Inventory-II (BDI-II)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Inventory of Interpersonal Problems (IIP-32)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Dyadic Adjustment Scale (DAS-12)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of University of Rhode Island Change Assessment (URICA-S, short version)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Burden Assessment Scale (BAS)(Baseline, 26th hour of therapy; 12 months after randomization)
- Change of Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP),(8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
- Change of Brief Symptom Checklist (BSCL)(Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization)
研究者
Christina Hunger
Principal Investigator
Heidelberg University