Clinical trial NCT00434759: Social Phobia Intervention Study of Mannheim
Official title: Evaluation of the Efficacy, Mechanisms of Change and Efficiency of a Stepped-care Program With a Computer-based Self-help Module and Minimal Therapist Contact in Comparison to a Standard Cognitive Therapy for Patients With Social Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Keywords: randomized controlled trial
stepped-care program
cognitive therapy of social phobia according to D.M. Clark
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-02-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: With prevalence rates (lifetime) up to 13% in western countries, Social Phobia is one of the most frequent mental disorders. Main objective of this clinical trial is the evaluation of the efficacy and efficiency of a stepped care program for patients with Social Phobia (SCP) as compared to a standard therapy (ST) for patients with social phobia. Both interventions are based on the cognitive therapy according to D.M. Clark.

The SCP starts with a 8-sessions self-help-module with minimal therapist contact via email. Patients who do not reach remission after this first step, enter step 2 which consists of 8 therapy sessions guided by a therapist. If patients are not remitted after that, they receive another 8 sessions of therapist-guided cognitive treatment in step 3. So the SCP contains 8, 16 or 24 sessions of therapy - depending on remission status of the patient. In contrast to that, the ST comprises 16 sessions of therapist-guided intervention.

The diagnostic status of the patients is assessed by blinded clinician raters before treatment, after every eighth therapy session, and at 5 follow-up timepoints in order to examine the stability of treatment effects (3, 6, 9, 12 and 30 months after the end of therapy). Besides efficacy and efficiency of the SCP vs. ST, mechanisms of change and differential predictors for therapy outcome will be investigated.

Hypotheses: We expect that

1. the SCP is significantly more effective than the ST.
2. the SCP is significantly more efficient than the ST.
3. the results referring to the efficacy will be stable up to 30 months after the end of treatment(Follow Up Phase).
4. the SCP will cause less primary and secondary costs than the ST.
5. successful therapy leads to an improvement in the following areas:

   * reduction of biased information processing,
   * reduction of negative thoughts, subjective anxiety, safety behaviors, self-focused attention and autonomic arousal in anxiety-provoking situations,
   * amelioration of verbal and non-verbal social competence in anxiety- provoking situations.

As mediators of change, the factors maintaining social anxiety according to the model of Social Phobia by Clark and Wells (1995) will be investigated.

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)

Primary outcomes:
measure: Change From Baseline in Social Interaction Anxiety Scale (SIAS)
timeFrame: baseline to post-treatment (on average 24 weeks)
measure: Change From Baseline in Social Phobia Scale (SPS)
timeFrame: baseline to post-treatment (on average 24 weeks)
measure: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)
timeFrame: baseline to post-treatment (on average 24 weeks)
Secondary outcomes:
measure: Change From Baseline in Brief Symptom Inventory (BSI)
timeFrame: baseline to post-treatment (on average 24 weeks)
measure: Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: baseline to post-treatment (on average 24 weeks)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
state: Baden-Württemberg
Study officials:
affiliation: Central Institute of Mental Health in Mannheim
name: Martin Bohus, MD
role: STUDY_DIRECTOR
References: