Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Systemic Therapy for Social Anxiety Disorder
* Behavioral: Cognitive Behavioral Therapy for Social Anxiety Disorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Acute drug or alcohol intoxication or dependency Anorexia with BMI < 14 Psychotic disorder Severe physical diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systemic Therapy<br>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. | Behavioral: Systemic Therapy for Social Anxiety Disorder<br> <br> |
| Experimental: Cognitive Behavioral Therapy<br>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. | Behavioral: Cognitive Behavioral Therapy for Social Anxiety Disorder<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Liebowitz Social Anxiety Scale (LSAS-SR) | 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 | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Social Interaction Anxiety Scale (SIAS) | Measure of social interaction anxiety, 20 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Social Phobia Scale (SPS) | Measure of anxiety while being observed by others, 20 items, German version | Baseline, 8th,15th and 20th hour of therapy, end of treatment; 6, 9 and 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Adjustment to Symptomatology Scale (ASS) | Measure of adjustment to the symptomatology, 5 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Evaluation of Social Systems (EVOS) | Measure of social relationships in different social systems, 10 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Experience in Social Systems (EXIS) | Measure of the individual experience in different social systems, 24 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Beck Depression Inventory-II (BDI-II) | Severity of depressive symptoms at that moment, specifically assessing the intensity of depression in psychiatric and normal populations, 21 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Brief Symptom Checklist (BSCL) | The instrument provides an overview of a patient's symptoms and their intensity at a specific point in time, 53 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Inventory of Interpersonal Problems (IIP-32) | The IIP-32 is a self-report instrument that identifies a person's most salient interpersonal difficulties. It is a short version of the Inventory of Interpersonal Problems, 32 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Dyadic Adjustment Scale (DAS-12) | Measure of relationship adjustment, 12 items, German version | 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) | Measure of stages of change, 16 items, German version | Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization | 
| Change of Burden Assessment Scale (BAS) | Measure of perceived burden in daily life among resource persons, 19 items, German version | Baseline, 26th hour of therapy; 12 months after randomization | 
| Change of Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP), | Measure of the six dimensions of resource activation, problem actuation, mastery, clarification of meaning, emotional bond, agreement on collaboration, 21 items, German version | 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization |