Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Systemic Therapy for Social Anxiety Disorder
Cognitive Behavioral Therapy for Social Anxiety Disorder
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
Eligibility 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
Sites / Locations
- Institute of Medical Psychology, University Hospital Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Systemic Therapy
Cognitive Behavioral Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Change of Social Interaction Anxiety Scale (SIAS)
Measure of social interaction anxiety, 20 items, German version
Change of Social Phobia Scale (SPS)
Measure of anxiety while being observed by others, 20 items, German version
Secondary Outcome Measures
Change of Adjustment to Symptomatology Scale (ASS)
Measure of adjustment to the symptomatology, 5 items, German version
Change of Evaluation of Social Systems (EVOS)
Measure of social relationships in different social systems, 10 items, German version
Change of Experience in Social Systems (EXIS)
Measure of the individual experience in different social systems, 24 items, German version
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
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
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
Change of Dyadic Adjustment Scale (DAS-12)
Measure of relationship adjustment, 12 items, German version
Change of University of Rhode Island Change Assessment (URICA-S, short version)
Measure of stages of change, 16 items, German version
Change of Burden Assessment Scale (BAS)
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),
Measure of the six dimensions of resource activation, problem actuation, mastery, clarification of meaning, emotional bond, agreement on collaboration, 21 items, German version
Full Information
NCT ID
NCT02360033
First Posted
January 21, 2015
Last Updated
October 16, 2019
Sponsor
Heidelberg University
Collaborators
German Association for Systemic Therapy, Counseling and Family Therapy (DGSF), Systemic Society (SG), Heidehof Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02360033
Brief Title
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders
Official Title
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
German Association for Systemic Therapy, Counseling and Family Therapy (DGSF), Systemic Society (SG), Heidehof Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systemic Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Systemic Therapy for Social Anxiety Disorder
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Social Anxiety Disorder
Primary Outcome Measure Information:
Title
Change of Liebowitz Social Anxiety Scale (LSAS-SR)
Description
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
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Social Interaction Anxiety Scale (SIAS)
Description
Measure of social interaction anxiety, 20 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Social Phobia Scale (SPS)
Description
Measure of anxiety while being observed by others, 20 items, German version
Time Frame
Baseline, 8th,15th and 20th hour of therapy, end of treatment; 6, 9 and 12 months after randomization
Secondary Outcome Measure Information:
Title
Change of Adjustment to Symptomatology Scale (ASS)
Description
Measure of adjustment to the symptomatology, 5 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Evaluation of Social Systems (EVOS)
Description
Measure of social relationships in different social systems, 10 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Experience in Social Systems (EXIS)
Description
Measure of the individual experience in different social systems, 24 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Beck Depression Inventory-II (BDI-II)
Description
Severity of depressive symptoms "at that moment", specifically assessing the intensity of depression in psychiatric and normal populations, 21 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Brief Symptom Checklist (BSCL)
Description
The instrument provides an overview of a patient's symptoms and their intensity at a specific point in time, 53 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Inventory of Interpersonal Problems (IIP-32)
Description
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
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Dyadic Adjustment Scale (DAS-12)
Description
Measure of relationship adjustment, 12 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of University of Rhode Island Change Assessment (URICA-S, short version)
Description
Measure of stages of change, 16 items, German version
Time Frame
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Title
Change of Burden Assessment Scale (BAS)
Description
Measure of perceived burden in daily life among resource persons, 19 items, German version
Time Frame
Baseline, 26th hour of therapy; 12 months after randomization
Title
Change of Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP),
Description
Measure of the six dimensions of resource activation, problem actuation, mastery, clarification of meaning, emotional bond, agreement on collaboration, 21 items, German version
Time Frame
8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Hunger, Dr.
Organizational Affiliation
Institute of Medical Psychology, University Hospital Heidelberg/Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jochen Schweitzer, Prof. Dr.
Organizational Affiliation
Institute of Medical Psychology, University Hospital Heidelberg/Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hinrich Bents, Dr.
Organizational Affiliation
Centre for Psychological Psychotherapy Heidelberg (ZPP)
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Medical Psychology, University Hospital Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27029546
Citation
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.
Results Reference
derived
Links:
URL
https://www.klinikum.uni-heidelberg.de/
Description
Related Info
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Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders
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