Skip to main content
OpenTrials
Completed

NCT Number: NCT02360033

Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Psychology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systemic Therapy for Social Anxiety Disorder

Behavioral

Cognitive Behavioral Therapy for Social Anxiety Disorder

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • German Association for Systemic Therapy, Counseling and Family Therapy (DGSF)
  • Heidehof Foundation
  • Systemic Society (SG)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2015
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.