Study Results
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View full resultsBasic Information
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COMPLETED
NA
89 participants
INTERVENTIONAL
2006-09-30
2011-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
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
ST
A standard therapy which means a therapist-guided intervention with 16 sessions face-to-face therapy.
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
60 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
Central Institute of Mental Health, Mannheim
OTHER
Responsible Party
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Principal Investigators
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Martin Bohus, MD
Role: STUDY_DIRECTOR
Central Institute of Mental Health in Mannheim
Locations
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Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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SP-32000
Identifier Type: -
Identifier Source: org_study_id