Social Phobia Intervention Study of Mannheim
Condition: Social Phobia
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional

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.
    

Intervention name(s): cognitive therapy; stepped care program based on cognitive therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments; starting with a digital-video-disk-based (DVD-based) self-help module (8 Sessions) followed by face-to-face-therapy including 8 or 16 sessions depending on remission status; including: changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
Other intervention name(s): cognitive therapy of social phobia according to D.M. Clark; based on cognitive therapy for social phobie by Clark & Wells (1995)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized controlled trial; stepped-care program; cognitive therapy of social phobia according to D.M. Clark