Social PhobiaNCT00434759
Social Phobia Intervention Study of Mannheim
A study testing cognitive therapy and stepped care program based on cognitive therapy in people with Social Phobia, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- cognitive therapy and stepped care program based on cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
About this study
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
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.
Read the 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
- 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:
- 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
- Social Phobia
- Being tested
- cognitive therapy, stepped care program based on cognitive therapy
- Keywords
- randomized controlled trial, stepped-care program, cognitive therapy of social phobia according to D.M. Clark
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive therapyBehavioural
Also called cognitive therapy of social phobia according to D.M. Clark
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 therapyBehavioural
Also called based on cognitive therapy for social phobie by Clark & Wells (1995)
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: stepped care program based on cognitive therapy |
| ST | Active comparator | A standard therapy which means a therapist-guided intervention with 16 sessions face-to-face therapy. Receives: Behavioral: cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline to post-treatment (on average 24 weeks)
Secondary outcomes (2)
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.
Measured: baseline to post-treatment (on average 24 weeks)
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.
Measured: baseline to post-treatment (on average 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionMay 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Martin Bohus, MD, Study director, Central Institute of Mental Health in Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434759
- Sponsor's protocol ID
- SP-32000
- Status last verified
- Oct 2012
- First submitted
- 9 Feb 2007
- Last updated
- 28 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00434759
- Acronym / sponsor ID
- SP-32000
- Conditions
- Social Phobia
- Keywords
- randomized controlled trial, stepped-care program, cognitive therapy of social phobia according to D.M. Clark
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Sep 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Posted 28 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCP | Active comparator | Behavioral: stepped care program based on cognitive therapySCP 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 | Behavioral: cognitive therapyA standard therapy which means a therapist-guided intervention with 16 sessions face-to-face therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive therapyAlso: cognitive therapy of social phobia according to D.M. Clarkchanging safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments | Behavioural | ST |
| stepped care program based on cognitive therapyAlso: based on cognitive therapy for social phobie by Clark & Wells (1995)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 | Behavioural | SCP |
Primary outcome
Change From Baseline in Social Interaction Anxiety Scale (SIAS)
Time frame: baseline to post-treatment (on average 24 weeks)
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)
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)
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.
2 secondary outcomes
Change From Baseline in Brief Symptom Inventory (BSI)
Time frame: baseline to post-treatment (on average 24 weeks)
Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline to post-treatment (on average 24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Bohus, MD study director
Central Institute of Mental Health in Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive therapy and stepped care program based on cognitive therapy in people with Social Phobia, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Social Interaction Anxiety Scale (SIAS) (time frame: baseline to post-treatment (on average 24 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.