Social Anxiety DisorderNCT02360033
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders
A study testing Systemic Therapy for Social Anxiety Disorder and Cognitive Behavioral Therapy for Social Anxiety Disorder in people with Social Anxiety Disorder, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Systemic Therapy for Social Anxiety Disorder and Cognitive Behavioral Therapy for Social Anxiety Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute drug or alcohol intoxication or dependency
- Anorexia with BMI < 14
- Psychotic disorder
- Severe physical diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Psychology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
About this study
Official title: 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).
Read more
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
- Being tested
- Systemic Therapy for Social Anxiety Disorder, Cognitive Behavioral Therapy for Social Anxiety Disorder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic Therapy for Social Anxiety DisorderBehavioural
Cognitive Behavioral Therapy for Social Anxiety DisorderBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Behavioral Therapy for Social Anxiety Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measure of adjustment to the symptomatology, 5 items, German version
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Change of Evaluation of Social Systems (EVOS)
Measure of social relationships in different social systems, 10 items, German version
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Change of Experience in Social Systems (EXIS)
Measure of the individual experience in different social systems, 24 items, German version
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
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
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
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
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
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
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Change of Dyadic Adjustment Scale (DAS-12)
Measure of relationship adjustment, 12 items, German version
Measured: 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)
Measure of stages of change, 16 items, German version
Measured: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Change of Burden Assessment Scale (BAS)
Measure of perceived burden in daily life among resource persons, 19 items, German version
Measured: Baseline, 26th hour of therapy; 12 months after randomization
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
Measured: 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- German Association for Systemic Therapy, Counseling and Family Therapy (DGSF), Systemic Society (SG), Heidehof Foundation
- Responsible party
- Principal investigator, Christina Hunger, Heidelberg University
- Investigators
- Christina Hunger, Dr., Study director, Institute of Medical Psychology, University Hospital Heidelberg/GermanyJochen Schweitzer, Prof. Dr., Study chair, Institute of Medical Psychology, University Hospital Heidelberg/GermanyHinrich Bents, Dr., Study chair, Centre for Psychological Psychotherapy Heidelberg (ZPP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360033
- Sponsor's protocol ID
- SOPHO-PT-2014
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2015
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27029546
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study
- ClinicalTrials.gov ID
- NCT02360033
- Acronym / sponsor ID
- SOPHO-PT-2014
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- German Association for Systemic Therapy, Counseling and Family Therapy (DGSF), Systemic Society (SG), Heidehof Foundation
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Therapy | Experimental | Behavioral: Systemic Therapy for Social Anxiety DisorderSystemic 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 | Experimental | Behavioral: Cognitive Behavioral Therapy for Social Anxiety DisorderCognitive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Acute drug or alcohol intoxication or dependency
- Anorexia with BMI < 14
- Psychotic disorder
- Severe physical diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic Therapy for Social Anxiety Disorder | Behavioural | Systemic Therapy |
| Cognitive Behavioral Therapy for Social Anxiety Disorder | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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
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
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
10 secondary outcomes
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
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
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
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
Change of Brief Symptom Checklist (BSCL)
Time frame: 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
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
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
Change of Burden Assessment Scale (BAS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Derived from this study: PubMed 27029546Hunger 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Hunger, Dr. study director
Institute of Medical Psychology, University Hospital Heidelberg/Germany
Jochen Schweitzer, Prof. Dr. study chair
Institute of Medical Psychology, University Hospital Heidelberg/Germany
Hinrich Bents, Dr. study chair
Centre for Psychological Psychotherapy Heidelberg (ZPP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic Therapy for Social Anxiety Disorder and Cognitive Behavioral Therapy for Social Anxiety Disorder in people with Social Anxiety Disorder, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.