Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360033
• Other study ID #: SOPHO-PT-2014
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2019
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Systemic Therapy for Social Anxiety Disorder

• Cognitive Behavioral Therapy for Social Anxiety Disorder

Locations

Country	Name	City	State
Germany	Institute of Medical Psychology, University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (4)

Lead Sponsor	Collaborator
Heidelberg University	German Association for Systemic Therapy, Counseling and Family Therapy (DGSF), Heidehof Foundation, Systemic Society (SG)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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