Social Phobia Intervention Study of Mannheim

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00434759
First received: February 9, 2007
Last updated: October 28, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Social Phobia
Behavioral: cognitive therapy
Behavioral: stepped care program based on cognitive therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • Change From Baseline in Social Interaction Anxiety Scale (SIAS) [ Time Frame: baseline to post-treatment (on average 24 weeks) ] [ Designated as safety issue: No ]
    This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.

  • Change From Baseline in Social Phobia Scale (SPS) [ Time Frame: baseline to post-treatment (on average 24 weeks) ] [ Designated as safety issue: No ]
    The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.

  • Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: baseline to post-treatment (on average 24 weeks) ] [ Designated as safety issue: No ]
    The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.


Secondary Outcome Measures:
  • Change From Baseline in Brief Symptom Inventory (BSI) [ Time Frame: baseline to post-treatment (on average 24 weeks) ] [ Designated as safety issue: No ]
    The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.

  • Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: baseline to post-treatment (on average 24 weeks) ] [ Designated as safety issue: No ]
    The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.


Enrollment: 89
Study Start Date: September 2006
Study Completion Date: December 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SCP
SCP is a stepped-care program with a self-help module with minimal therapist contact (8 sessions) as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to a maximum of 16 sessions).
Behavioral: stepped care program based on cognitive therapy
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 Name: based on cognitive therapy for social phobie by Clark & Wells (1995)
Active Comparator: ST
A standard therapy which means a therapist-guided intervention with 16 sessions face-to-face therapy.
Behavioral: cognitive therapy
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 Name: cognitive therapy of social phobia according to D.M. Clark

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434759

Locations
Germany
Central Institute of Mental Health
Mannheim, Baden-Württemberg, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Research Foundation
Investigators
Study Director: Martin Bohus, MD Central Institute of Mental Health in Mannheim
  More Information

No publications provided

Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT00434759     History of Changes
Other Study ID Numbers: SP-32000
Study First Received: February 9, 2007
Results First Received: November 29, 2011
Last Updated: October 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Central Institute of Mental Health, Mannheim:
randomized controlled trial
stepped-care program
cognitive therapy of social phobia according to D.M. Clark

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014