Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00434759
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2007-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Social Phobia Intervention Study of Mannheim
Sponsor:
Central Institute of Mental Health, Mannheim
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: