Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

Interventions

  • Behavioral: Systemic Therapy for Social Anxiety Disorder
  • Behavioral: Cognitive Behavioral Therapy for Social Anxiety Disorder

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change of Liebowitz Social Anxiety Scale (LSAS-SR)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heidelberg University
  • Collaborator
    • German Association for Systemic Therapy, Counseling and Family Therapy (DGSF)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christina Hunger, Principal Investigator – Heidelberg University
  • Overall Official(s)
    • Christina Hunger, Dr., Study Director, Institute of Medical Psychology, University Hospital Heidelberg/Germany
    • Jochen Schweitzer, Prof. Dr., Study Chair, Institute of Medical Psychology, University Hospital Heidelberg/Germany
    • Hinrich Bents, Dr., Study Chair, Centre for Psychological Psychotherapy Heidelberg (ZPP)

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