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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Therapy | Active Comparator | Cognitive Therapy |
|
| Seroxat and SE | Active Comparator | SSRI with Self exposure |
|
| Seroxat and Cognitive Therapy | Active Comparator | Combination of Seroxat and Cognitive Therapy |
|
| Pill-Placebo | Placebo Comparator | Pill Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroxat, Cognitive therapy, Seroxat+ cognitive therapy | Drug | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate during 6 and 12 months of follow up. | December 2010 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans M Nordahl, Professor | Norwegian University of Science and Technology, NTNU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Psychology, NTNU | Trondheim | Dragvoll | 7491 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27744447 | Result | Nordahl HM, Vogel PA, Morken G, Stiles TC, Sandvik P, Wells A. Paroxetine, Cognitive Therapy or Their Combination in the Treatment of Social Anxiety Disorder with and without Avoidant Personality Disorder: A Randomized Clinical Trial. Psychother Psychosom. 2016;85(6):346-356. doi: 10.1159/000447013. Epub 2016 Oct 15. | |
| 28295802 | Result |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001521 | Behavior Therapy |
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|
| Nordahl H, Nordahl HM, Hjemdal O, Wells A. Cognitive and metacognitive predictors of symptom improvement following treatment for social anxiety disorder: A secondary analysis from a randomized controlled trial. Clin Psychol Psychother. 2017 Nov;24(6):1221-1227. doi: 10.1002/cpp.2083. Epub 2017 Mar 15. |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |