Clinical trial NCT02360033: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Association for Systemic Therapy, Counseling and Family Therapy (DGSF)
name: Systemic Society (SG)
name: Heidehof Foundation
First posted: 2015-02-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of Liebowitz Social Anxiety Scale (LSAS-SR)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Social Interaction Anxiety Scale (SIAS)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Social Phobia Scale (SPS)
timeFrame: Baseline, 8th,15th and 20th hour of therapy, end of treatment; 6, 9 and 12 months after randomization
Secondary outcomes:
measure: Change of Adjustment to Symptomatology Scale (ASS)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Evaluation of Social Systems (EVOS)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Experience in Social Systems (EXIS)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Brief Symptom Checklist (BSCL)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Inventory of Interpersonal Problems (IIP-32)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Dyadic Adjustment Scale (DAS-12)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of University of Rhode Island Change Assessment (URICA-S, short version)
timeFrame: Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
measure: Change of Burden Assessment Scale (BAS)
timeFrame: Baseline, 26th hour of therapy; 12 months after randomization
measure: Change of Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP),
timeFrame: 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Institute of Medical Psychology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Institute of Medical Psychology, University Hospital Heidelberg/Germany
name: Christina Hunger, Dr.
role: STUDY_DIRECTOR
affiliation: Institute of Medical Psychology, University Hospital Heidelberg/Germany
name: Jochen Schweitzer, Prof. Dr.
role: STUDY_CHAIR
affiliation: Centre for Psychological Psychotherapy Heidelberg (ZPP)
name: Hinrich Bents, Dr.
role: STUDY_CHAIR
References:
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.