Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=89 Randomized Single-blind Treatment

Social Phobia Intervention Study of Mannheim

Social Phobia

Bottom Line

View on ClinicalTrials.gov: NCT00434759 ↗
Enrolled (actual)
89
Serious AEs
—
Results posted
Nov 2012
Primary outcome: Primary: Change From Baseline in Social Interaction Anxiety Scale (SIAS) — 43.13; 48.94; 34.85; 33.35 units on a scale — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
cognitive therapy (Behavioral); stepped care program based on cognitive therapy (Behavioral)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Central Institute of Mental Health, Mannheim
Primary completion
May 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Social Interaction Anxiety Scale (SIAS)		 43.13; 48.94; 34.85; 33.35 <0.05 sig
PRIMARY
Change From Baseline in Social Phobia Scale (SPS)		 35.85; 33.95; 24.89; 17.58 <0.05 sig
PRIMARY
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)		 57.46; 60.58; 41.22; 31.84 <0.05 sig
SECONDARY
Change From Baseline in Brief Symptom Inventory (BSI)		 1.00; 0.90; 0.71; 0.51 <0.05 sig
SECONDARY
Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)		 21.48; 21.47; 16.20; 14.28 <0.05 sig

Summary

Primary objective: The purpose of this study is to examine efficacy and efficiency of a Stepped Care Program (SCP) for patients with Social Phobia in comparison to the standard cognitive therapy for Social Phobia according to D.M. Clark. Secondary objective: Further, it is intended to identify mechanisms of change which mediate treatment outcome and to identify differential predictors for therapy success for the two treatment conditions.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Social Phobia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)
  • Duration of the disorder at least 1 year
  • Severity of symptomatology according to at least one of two self-report measures for social anxiety above Cut-Off: Social Interaction Anxiety Scale (SIAS: value of 26 or more) and / or Social Phobia Scale (SPS: value of 17 or more)
  • Age: 18-60
  • Written Informed Consent

Exclusion Criteria

  • Social Phobia is not the main diagnosis
  • Mental Retardation
  • Lifetime Diagnoses: Schizophreniform Disorder, Bipolar Affective Disorder
  • Acute Diagnoses: severe Major Depression Episode, severe Anorexia Nervosa, Substance-, Drug - or Alcohol-Dependence, life-threatening suicidal crisis
  • Psychotropic medication (except stable treatment with antidepressant since 3 months before study start: medication and dosage has to be stable during the entire study duration)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00434759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search