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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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
the SCP is significantly more effective than the ST.
the SCP is significantly more efficient than the ST.
the results referring to the efficacy will be stable up to 30 months after the end of treatment(Follow Up Phase).
the SCP will cause less primary and secondary costs than the ST.
successful therapy leads to an improvement in the following areas:
As mediators of change, the factors maintaining social anxiety according to the model of Social Phobia by Clark and Wells (1995) will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCP | Active Comparator | 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). |
|
| ST | Active Comparator | A standard therapy which means a therapist-guided intervention with 16 sessions face-to-face therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive therapy | Behavioral | changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Social Interaction Anxiety Scale (SIAS) | 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. | baseline to post-treatment (on average 24 weeks) |
| Change From Baseline in Social Phobia Scale (SPS) | 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. | baseline to post-treatment (on average 24 weeks) |
| Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | 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. | baseline to post-treatment (on average 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Symptom Inventory (BSI) | 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. | baseline to post-treatment (on average 24 weeks) |
| Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bohus, MD | Central Institute of Mental Health in Mannheim | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Care Program | stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission |
| FG001 | Standardtherapy | standard therapy (therapist-guided intervention only) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepped Care Program | stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission |
| BG001 | Standardtherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Social Interaction Anxiety Scale (SIAS) | 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | baseline to post-treatment (on average 24 weeks) |
|
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No serious and/or other adverse events were assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped Care Program | stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Martin Bohus | Central Institute of Mental Health, Mannheim, Germany | +49 621 1703 4002 | martin.bohus@zi-mannheim.de |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D060986 | Water Wells |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D014881 | Water Supply |
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|
| stepped care program based on cognitive therapy | Behavioral | 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 |
|
|
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. |
| baseline to post-treatment (on average 24 weeks) |
| family affairs |
|
standard therapy (therapist-guided intervention only)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
standard therapy (therapist-guided intervention only; 16 sessions)
|
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|
| Secondary | Change From Baseline in Brief Symptom Inventory (BSI) | 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | baseline to post-treatment (on average 24 weeks) |
|
|
|
|
| Secondary | Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | baseline to post-treatment (on average 24 weeks) |
|
|
|
|
| Primary | Change From Baseline in Social Phobia Scale (SPS) | 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | baseline to post-treatment (on average 24 weeks) |
|
|
|
|
| Primary | Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | baseline to post-treatment (on average 24 weeks) |
|
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standardtherapy | standard therapy (therapist-guided intervention only) | 0 | 0 | 0 | 0 |
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| D012498 |
| Sanitary Engineering |
| D004738 | Engineering |
| D013676 | Technology, Industry, and Agriculture |