The University of Southampton
University of Southampton Institutional Repository

Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia

Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia
Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia
Background: Generalized social phobia is common, persistent, and disabling and is often treated with selective serotonin reuptake inhibitor drugs or cognitive behavioral therapy.

Objective: We compared fluoxetine (FLU), comprehensive cognitive behavioral group therapy (CCBT), placebo (PBO), and the combinations of CCBT/FLU and CCBT/PBO.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Two academic outpatient psychiatric centers.

Patients: Subjects meeting a primary diagnosis of generalized social phobia were recruited via advertisement. Seven hundred twenty-two were screened, and 295 were randomized and available for inclusion in an intention-to-treat efficacy analysis; 156 (52.9%) were male, 226 (76.3%) were white, and mean age was 37.1 years.

Interventions: Treatment lasted for 14 weeks. Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d (or equivalent). Group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions.

Main Outcome Measures: An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes. A videotaped behavioral assessment served as a secondary outcome, using the Subjective Units of Distress Scale. Adverse effects were measured by self-rating. Each treatment was compared by means of 2 tests and piecewise linear mixed-effects models.

Results: Clinical Global Impressions scales response rates in the intention-to-treat sample were 29 (50.9%) (FLU), 31 (51.7%) (CCBT), 32 (54.2%) (CCBT/FLU), 30 (50.8%) (CCBT/PBO), and 19 (31.7%) (PBO), with all treatments being significantly better than PBO. On the Brief Social Phobia Scale, all active treatments were superior to PBO. In the linear mixed-effects models analysis, FLU was more effective than CCBT/FLU, CCBT/PBO, and PBO at week 4; CCBT was also more effective than CCBT/FLU and CCBT/PBO. By the final visit, all active treatments were superior to PBO but did not differ from each other. Site effects were found for the Subjective Units of Distress Scale assessment, with FLU and CCBT/FLU superior to PBO at Duke University Medical Center, Durham, NC. Treatments were well tolerated.

Conclusions: All active treatments were superior to PBO on primary outcomes. Combined treatment did not yield any further advantage. Notwithstanding the benefits of treatment, many patients remained symptomatic after 14 weeks.

0003-990X
1005-1013
Davidson, Jonathan R.T.
1c4d8510-4b2b-4775-b5a2-b9a08b9556ac
Foa, Edna B.
b6d08348-b9da-45a9-8082-2c78bb5084b9
Huppert, Jonathan D.
7f756560-668a-4b82-b736-12c3df8dca8a
Keefe, Francis J.
5c2a53e1-5031-4ecc-aa34-80641985a68e
Franklin, Martin E.
6287d225-1ba1-4848-a43b-2686f863f316
Compton, Jill S.
8c685f2d-769b-4f08-b142-0529dc3ef523
Zhao, Ning
ebe0ac3e-53bd-43fd-b633-1264307d3a04
Connor, Kathryn M.
1f63eaf1-4014-45bf-a8eb-9449321ac989
Lynch, Thomas R.
29e90123-0aef-46c8-b320-1617fb48bb20
Gadde, Kishore M.
4b266d90-6eb2-4ae6-b678-3763cb0dce85
Davidson, Jonathan R.T.
1c4d8510-4b2b-4775-b5a2-b9a08b9556ac
Foa, Edna B.
b6d08348-b9da-45a9-8082-2c78bb5084b9
Huppert, Jonathan D.
7f756560-668a-4b82-b736-12c3df8dca8a
Keefe, Francis J.
5c2a53e1-5031-4ecc-aa34-80641985a68e
Franklin, Martin E.
6287d225-1ba1-4848-a43b-2686f863f316
Compton, Jill S.
8c685f2d-769b-4f08-b142-0529dc3ef523
Zhao, Ning
ebe0ac3e-53bd-43fd-b633-1264307d3a04
Connor, Kathryn M.
1f63eaf1-4014-45bf-a8eb-9449321ac989
Lynch, Thomas R.
29e90123-0aef-46c8-b320-1617fb48bb20
Gadde, Kishore M.
4b266d90-6eb2-4ae6-b678-3763cb0dce85

Davidson, Jonathan R.T., Foa, Edna B., Huppert, Jonathan D., Keefe, Francis J., Franklin, Martin E., Compton, Jill S., Zhao, Ning, Connor, Kathryn M. and Lynch, Thomas R. , Gadde, Kishore M. (ed.) (2004) Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia. Archives of General Psychiatry, 61 (10), 1005-1013. (PMID:15466674)

Record type: Article

Abstract

Background: Generalized social phobia is common, persistent, and disabling and is often treated with selective serotonin reuptake inhibitor drugs or cognitive behavioral therapy.

Objective: We compared fluoxetine (FLU), comprehensive cognitive behavioral group therapy (CCBT), placebo (PBO), and the combinations of CCBT/FLU and CCBT/PBO.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Two academic outpatient psychiatric centers.

Patients: Subjects meeting a primary diagnosis of generalized social phobia were recruited via advertisement. Seven hundred twenty-two were screened, and 295 were randomized and available for inclusion in an intention-to-treat efficacy analysis; 156 (52.9%) were male, 226 (76.3%) were white, and mean age was 37.1 years.

Interventions: Treatment lasted for 14 weeks. Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d (or equivalent). Group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions.

Main Outcome Measures: An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes. A videotaped behavioral assessment served as a secondary outcome, using the Subjective Units of Distress Scale. Adverse effects were measured by self-rating. Each treatment was compared by means of 2 tests and piecewise linear mixed-effects models.

Results: Clinical Global Impressions scales response rates in the intention-to-treat sample were 29 (50.9%) (FLU), 31 (51.7%) (CCBT), 32 (54.2%) (CCBT/FLU), 30 (50.8%) (CCBT/PBO), and 19 (31.7%) (PBO), with all treatments being significantly better than PBO. On the Brief Social Phobia Scale, all active treatments were superior to PBO. In the linear mixed-effects models analysis, FLU was more effective than CCBT/FLU, CCBT/PBO, and PBO at week 4; CCBT was also more effective than CCBT/FLU and CCBT/PBO. By the final visit, all active treatments were superior to PBO but did not differ from each other. Site effects were found for the Subjective Units of Distress Scale assessment, with FLU and CCBT/FLU superior to PBO at Duke University Medical Center, Durham, NC. Treatments were well tolerated.

Conclusions: All active treatments were superior to PBO on primary outcomes. Combined treatment did not yield any further advantage. Notwithstanding the benefits of treatment, many patients remained symptomatic after 14 weeks.

Full text not available from this repository.

More information

Published date: October 2004

Identifiers

Local EPrints ID: 194225
URI: http://eprints.soton.ac.uk/id/eprint/194225
ISSN: 0003-990X
PURE UUID: d472f0ab-3f45-4578-8c1e-157e7ee8edf5
ORCID for Thomas R. Lynch: ORCID iD orcid.org/0000-0003-1270-6097

Catalogue record

Date deposited: 26 Jul 2011 09:12
Last modified: 17 Dec 2019 01:43

Export record

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×