RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo

Study Overview
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Brief Summary
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We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients' response to CT, to paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). All patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The 4th group will have placebo for 24 weeks and clinical management. The patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months. Measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.

Official Title
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A Randomised, Triple Blind, Placebo-controlled Trial Comparing the Effects of Cognitive Therapy, Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia

Conditions
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Phobic Disorders

Intervention / Treatment
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* Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent obtained prior to entry in the study. Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994). Symptoms present at least one year. Age between 18-65 years. Exclusion Criteria: Known somatic diseases. Pregnant (*) or lactating women. Psychosis Acute suicidal symptoms Major depressive disorder Generalized Anxiety Disorder or PTSD Cluster A or cluster B personality disorder Substance abuse or dependence Body dysmorphic disorder. Not willing to accept random allocation. Patients who take some form of SSRI medications currently or during the last 6 months Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial or are taking herbal remedies that may be hazardous or inflict treatment response.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Therapy<br>Cognitive Therapy | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy<br>* Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up<br>* Other names: Paroxetine;|
| Active Comparator: Seroxat and SE<br>SSRI with Self exposure | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy<br>* Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up<br>* Other names: Paroxetine;|
| Active Comparator: Seroxat and Cognitive Therapy<br>Combination of Seroxat and Cognitive Therapy | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy<br>* Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up<br>* Other names: Paroxetine;|
| Placebo Comparator: Pill-Placebo<br>Pill Placebo | Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy<br>* Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up<br>* Other names: Paroxetine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week. |  | December 2010 | 
| A patient is classified as responder if the decrease on FNE is equivalent with or above 40%. |  | December 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate during 6 and 12 months of follow up. |  | December 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phobic disorders, Therapy, cognitive, Paroxetine