Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02360033
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : October 16, 2019
Sponsor:
Collaborators:
German Association for Systemic Therapy, Counseling and Family Therapy (DGSF)
Systemic Society (SG)
Heidehof Foundation
Information provided by (Responsible Party):
Christina Hunger, Heidelberg University

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.


Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Systemic Therapy for Social Anxiety Disorder Behavioral: Cognitive Behavioral Therapy for Social Anxiety Disorder Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study
Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Behavioral: Systemic Therapy for Social Anxiety Disorder
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.
Behavioral: Cognitive Behavioral Therapy for Social Anxiety Disorder



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360033


Locations
Layout table for location information
Germany
Institute of Medical Psychology, University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69115
Sponsors and Collaborators
Heidelberg University
German Association for Systemic Therapy, Counseling and Family Therapy (DGSF)
Systemic Society (SG)
Heidehof Foundation
Investigators
Layout table for investigator information
Study Director: Christina Hunger, Dr. Institute of Medical Psychology, University Hospital Heidelberg/Germany
Study Chair: Jochen Schweitzer, Prof. Dr. Institute of Medical Psychology, University Hospital Heidelberg/Germany
Study Chair: Hinrich Bents, Dr. Centre for Psychological Psychotherapy Heidelberg (ZPP)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christina Hunger, Priv.-Doz., M.Sc., Dipl.-Psych., Heidelberg University
ClinicalTrials.gov Identifier: NCT02360033     History of Changes
Other Study ID Numbers: SOPHO-PT-2014
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders