Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

NCT02360033 | Completed

• 1 other identifier: SOPHO-PT-2014
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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 Brief Symptom Checklist (BSCL)

  Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization

Study Arms (2)

Systemic Therapy

EXPERIMENTAL

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

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Interventions

Systemic Therapy for Social Anxiety Disorder BEHAVIORAL

Systemic Therapy

Cognitive Behavioral Therapy for Social Anxiety Disorder BEHAVIORAL

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute drug or alcohol intoxication or dependency
• Anorexia with BMI \< 14
• Psychotic disorder
• Severe physical diseases

Sponsors & Collaborators

• Heidelberg University: lead
• German Association for Systemic Therapy, Counseling and Family Therapy (DGSF): collaborator
• Systemic Society (SG): collaborator
• Heidehof Foundation: collaborator

Study Sites (1)

Institute of Medical Psychology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Related Publications (1)

• Hunger C, Hilzinger R, Koch T, Mander J, Sander A, Bents H, Schweitzer J. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial. Trials. 2016 Mar 31;17:171. doi: 10.1186/s13063-016-1252-1.

  PMID: 27029546 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christina Hunger, Dr.

  Institute of Medical Psychology, University Hospital Heidelberg/Germany

  STUDY DIRECTOR

• Jochen Schweitzer, Prof. Dr.

  Institute of Medical Psychology, University Hospital Heidelberg/Germany

  STUDY CHAIR

• Hinrich Bents, Dr.

  Centre for Psychological Psychotherapy Heidelberg (ZPP)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 10, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

DE (1)