- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360033
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baden-Württemberg
-
Heidelberg, Baden-Württemberg, Germany, 69115
- Institute of Medical Psychology, University Hospital Heidelberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th and 20th hour of therapy, end of treatment; 6, 9 and 12 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
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
|
Baseline, 26th hour of therapy; 12 months after randomization
|
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
|
8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOPHO-PT-2014
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