Cognitive Therapy Versus Fluoxetine in Generalized Social Phobia:
A Randomized Placebo-Controlled Trial
David M. Clark, Anke Ehlers, and Freda McManus
Institute of Psychiatry
Ann Hackmann, Melanie Fennell, Helen Campbell,
Teresa Flower, Clare Davenport, and Beverley Louis
University of Oxford
Sixty patients meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American
Psychiatric Association, 1994) criteria for generalized social phobia were assigned to cognitive therapy
(CT), fluoxetine plus self-exposure (FLU SE), or placebo plus self-exposure (PLA SE). At
posttreatment (16 weeks), the medication blind was broken. CT and FLU SE patients then entered a
3-month booster phase. Assessments were at pretreatment, midtreatment, posttreatment, end of booster
phase, and 12-month follow-up. Significant improvements were observed on most measures in all 3
treatments. On measures of social phobia, CT was superior to FLU SE and PLA SE at midtreatment
and at posttreatment. FLU SE and PLA SE did not differ. CT remained superior to FLU SE at
the end of the booster period and at 12-month follow-up. On general mood measures, there were few
differences between the treatments.
Social phobia is a common and disabling disorder (Magee, Eaton,
Wittchen, Gonagle, & Kessler, 1996) that is associated with marked
vocational underachievement and an increased risk of depression,
suicide, and alcohol abuse (Heckelman & Schneier, 1995; Rapee,
1995). Onset is typically in adolescence or earlier (Rapee, 1995).
Perhaps because many patients see the disorder as part of their
personality, treatment-seeking rates are low in comparison with other
anxiety disorders, such as panic disorder (Fresco, Erwin, Heimberg, &
Turk, 2000; Magee et al., 1996). However, in the past 15 years
considerable progress has been made in developing effective pharma-
cological and psychological treatments.
Within pharmacological approaches (see Hood & Nutt, 2001,
for a review), the three best validated interventions are benzodi-
azepines, monoamine oxidase inhibitors, and selective serotonin
reuptake inhibitors (SSRIs). In several countries concerns about
dependency have led to the recommendation that benzodiazepines
should only be used for brief periods (e.g., Committee on Safety of
Medicines, 1988), which limits their utility in treating a chronic
condition such as social phobia. Phenelzine is the best validated
monoamine oxidase inhibitor. Three controlled trials (Heimberg et
al., 1998; Liebowitz et al., 1992; Versiani et al., 1992) have found
phenelzine superior to placebo. A fourth trial (Gelernter et al.,
1991) failed to find a significant difference between phenelzine
and placebo on the main social phobia measures but did find a
difference on a secondary measure of work and social disability.
Among the SSRIs, controlled trials have established superiority
over placebo medication for fluvoxamine (Stein, Fyer, Davidson,
Pollack, & Wiita, 1999), sertraline (Blomhoff et al., 2001; Van
Ameringen, Swinson, Walker, & Lane, 1999; Van Ameringen et
al., 2001), and paroxetine (Allgulander, 1999; Baldwin, Bobes,
Stein, Scharwa¨chter, & Faure, 1999; Stein et al., 1998).
Within psychological approaches, the best validated treatments
are behavioral and cognitive–behavioral. Five meta-analytic re-
views (Chambless & Hope, 1996; Fedoroff & Taylor, 2001; Feske
& Chambless, 1995; Gould, Buckminster, Pollack, Otto, & Yap,
1997; Taylor, 1996) have summarized studies comparing behav-
ioral and cognitive–behavioral treatments (CBTs) with various
control conditions, and each reached broadly similar conclusions.
Exposure alone and exposure with cognitive restructuring are both
associated with significantly greater effect sizes than are waiting
list control conditions. Individual studies have failed to provide
convincing evidence of a difference in efficacy between exposure
alone and exposure with cognitive restructuring. However, in one
meta-analysis (Taylor, 1996), only the combination of exposure
and cognitive restructuring was superior to placebo control condi-
tions. A particularly encouraging finding has been the excellent
maintenance of gains after the end of effective psychological
treatment. For example, Heimberg, Salzman, Holt, and Blendell
David M. Clark, Anke Ehlers, and Freda McManus, Department of
Psychology, Institute of Psychiatry, London, United Kingdom; Ann Hack-
mann, Melanie Fennell, Helen Campbell, Teresa Flower, Clare Davenport,
and Beverley Louis, Department of Psychiatry, University of Oxford,
Oxford, United Kingdom.
Freda McManus is now at Isis Education Centre, Warneford Hospital,
Oxford, United Kingdom. Helen Campbell is now at the Berkshire Health-
care National Health Service Trust, Reading, United Kingdom; Teresa
Flower is now at the Adolescent Forensic Health Service, Parkville, Vic-
toria, Australia; Clare Davenport is now at the Department of Public Health
and Epidemiology, University of Birmingham, Birmingham, United King-
dom; Beverley Louis is now at the Central Middlesex Hospital, London,
United Kingdom.
The research was funded by the Wellcome Trust. Anke Ehlers is a
Wellcome Principal Research Fellow. Eli Lilly provided the identically
packaged 20-mg capsules of fluoxetine and placebo. We are grateful to
Hester Barrington-Ward, Katie Bradbury, Jessica Bolton, Philip Cowen,
Christopher Fairburn, Carolyn Fordham, Michael Gelder, Antje Ho˝rst, and
Kate Telford for their assistance.
Correspondence concerning this article should be addressed to David M.
Clark, Department of Psychology, PO Box 77, Institute of Psychiatry, De
Crespigny Park, London SE5 8AF, United Kingdom. E-mail:
d.clark@iop.kcl.ac.uk
Journal of Consulting and Clinical Psychology Copyright 2003 by the American Psychological Association, Inc.
2003, Vol. 71, No. 6, 1058–1067 0022-006X/03/$12.00 DOI: 10.1037/0022-006X.71.6.1058
1058
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(1993) found that patients who received cognitive–behavioral
group treatment (CBGT) retained their gains at 5-year follow-up
and remained significantly less symptomatic than patients who had
received a control treatment (education-support).
Despite the positive findings reported for existing behavioral
and cognitive–behavioral treatments, it is generally agreed that
there is scope for further development. First, a significant subset of
patients fail to achieve optimal benefit from the existing treatment
programs. For example, in an intent-to-treat analysis, Heimberg et
al. (1998) reported that fewer than 60% of patients who received
CBGT were classified as treatment responders. Using a stricter
improvement criterion, Mattick and Peters (1988) reported that
only 38% of patients who completed their cognitive–behavioral
program were considered optimally improved (achieved high end-
state functioning). Second, one recent meta-analytic review (Fe-
doroff & Taylor, 2001) has concluded that pharmacotherapies
(particularly SSRIs) yield the largest initial effect sizes in social
phobia, although there is some evidence for greater relapse after
discontinuation of medication than after termination of CBT
(Liebowitz et al., 1999).
The present study reports a randomized controlled trial that
evaluated a new CBT and compared it with treatment with an
SSRI. The new CBT is the cognitive therapy (CT) program de-
veloped by Clark, Wells, and colleagues on the basis of their
cognitive model of social phobia. Clark and Wells’s (1995) cog-
nitive model, which is very similar to the model described by
Rapee and Heimberg (1997), is largely focused on the maintenance
of social phobia and attempts to explain why patients with social
phobia fail to benefit from the naturalistic exposure that is pro-
vided by their everyday interactions with other people. Four main-
tenance processes are particularly highlighted. The maintenance
processes are (a) an increase in self-focused attention and moni-
toring with a linked reduction in observation of other people and
their responses; (b) the use of misleading internal information
(particularly anxious feelings and spontaneously occurring, dis-
torted images of themselves seen from an observer perspective) to
make excessively negative inferences about how one appears to
others; (c) extensive use of safety behaviors that are intended to
prevent feared catastrophes but have the consequence of maintain-
ing negative beliefs, increasing feared symptoms, and making
patients come across to others in ways that are likely to elicit less
friendly responses (although termed behaviors, a substantial pro-
portion of the safety behaviors are cognitive strategies); and (d) the
use of negatively biased anticipatory and postevent processing.
The CT program includes a series of procedures that are specifi-
cally focused on reversing the maintaining processes specified in
the model.
The SSRI chosen for comparison with CT is fluoxetine. At the
time the trial was conducted, no controlled trials of fluoxetine had
been reported. However, five open trials of fluoxetine (Black,
Uhde, & Tancer, 1992; Koponen, Lepola, & Juhani, 1995; Perugi
et al., 1994; Schneier, Chin, Hollander, & Liebowitz, 1992; Van
Ameringen, Mancini, & Streiner, 1993) had obtained promising
results. Following the example of two previous pharmacotherapy
trials in social phobia (Blomhoff et al., 2001, with sertraline;
Gelernter et al., 1991, with phenelzine), fluoxetine was combined
with weekly self-exposure assignments. Combining medication
with self-exposure was intended to produce a closer approximation
to routine clinical practice, as it was thought that many United
Kingdom clinicians who use medication are likely to combine it
with a simple practical procedure such as self-exposure. To esti-
mate the extent to which improvements associated with fluoxetine
plus self-exposure were active pharmacological effects, we also
included a placebo plus self-exposure condition in the study.
Method
Design
Patients were initially randomly assigned to CT, fluoxetine plus self-
exposure (FLU SE), or placebo plus self-exposure (PLA SE). Allo-
cation to fluoxetine or placebo was double-blind. Patients had up to 16
weekly treatment sessions. After 16 weeks, the medication blind was
broken. Patients who were allocated to FLU SE continued their medi-
cation for 3 months and had up to three treatment sessions during this
booster period. Patients who were allocated to CT had the same number of
booster sessions. Patients initially allocated to placebo were withdrawn
from the trial at 16 weeks and offered their choice of CT, FLU SE, or
a combination of both treatments. Assessments, which included ratings
completed by an independent assessor, were at pretreatment, midtreatment,
posttreatment (16 weeks), end of the booster period, and 12-month
follow-up.
Patients
Local general practitioners, psychiatrists, and psychologists were sent a
letter requesting referrals to a trial of psychological and pharmacological
treatments for social phobia. Advertisements in the local press and shop-
ping centers also brought the trial to the attention of potential participants
(all of whom had to be referred by a clinician). Referrers were informed
that open trials suggested that CT and fluoxetine were both effective, and
it was not known which was more effective. Referred patients were
assessed using a combination of the Anxiety Disorders Interview Schedule
for DSM–IV (ADIS; Brown, Di Nardo, & Barlow, 1994) and the Structured
Clinical Interview for DSM–IV, Axis-I disorders (SCID-I; First, Spitzer,
Gibbon, & Williams, 1995). All patients were assessed with the overview
module of the SCID-I and the social phobia module of the ADIS. If the
SCID-I screener module indicated that another Axis-I disorder might be
present, the SCID-I module for that disorder was also administered. All
patients were also assessed with the Avoidant Personality Disorder section
of the SCID: Axis-II Disorders Interview (SCID-II; First, Gibbon, Spitzer,
Williams, & Benjamin, 1997). The Borderline Personality Disorder section
of SCID-II was administered if it was clinically relevant. Diagnostic
interviews were conducted by clinical psychologists who had received
extensive training in the SCID and ADIS. All diagnoses were also checked
with a senior clinician (David M. Clark). Patients were accepted if they met
the following criteria: (a) Diagnostic and Statistical Manual of Mental
Disorders (4th ed.; DSM–IV; American Psychiatric Association, 1994)
criteria for generalized social phobia;
1
(b) condition duration of at least 6
months; (c) social phobia was considered their main problem; (d) age
between 18 and 60 years; (e) willingness to accept random allocation; (f)
no current major depressive disorder, bipolar disorder, psychosis, alcohol
or substance dependency, or epilepsy; (g) not pregnant and had no intention
to become pregnant; (h) social phobia had not been previously treated with
an SSRI, CT, or exposure therapy; (i) no psychotropic medication use or,
1
Following the DSM–IV (American Psychiatric Association, 1994, pp.
412–413), we diagnosed the generalized subtype of social phobia if the
assessors considered that an individual’s fears “related to most social
situations” and involved fear of “both public performance situations and
social interaction situations.” Inspection of patients’ pretreatment Liebow-
itz Social Anxiety Scales (LSAS; Liebowitz, 1987) indicated that accepted
patients feared a median of 20 of the 24 situations specified on the scale
(range: 12–24).
1059
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alternatively, willingness to be withdrawn from medication before the start
of the trial (a minimum 4-week drug-free period was required before a
patient could start trial treatment); and (j) agreed not to start any additional
treatment during the trial. With the exception of borderline personality
disorder, Axis II personality disorders were not a reason for exclusion.
Of 123 social phobia patients referred for possible inclusion in the trial,
63 did not meet entry criteria. Reasons for exclusion were as follows: social
phobia was not the main problem (19 patients); participation was declined
(14 patients); previous treatment with an SSRI (9 patients); social phobia
was too mild or too specific (8 patients); use of medication with psycho-
tropic effects that would be medically inappropriate to withdraw (6 pa-
tients); previous CBT for social phobia (3 patients); current major depres-
sive disorder (3 patients); and borderline personality disorder (1 patient).
The remaining 60 patients met entry criteria and were allocated to treat-
ment (20 per condition) on a stratified random basis. Stratification vari-
ables were gender (male, female) and avoidant personality disorder
(present, absent). Within each of the stratification cells, sealed allocations
were drawn at random.
Treatments
CT. CT was based on Clark and Wells’s (1995) model of the mainte-
nance of social phobia and used a variety of procedures to reverse the
maintaining factors identified in the model. The procedures were described
in detail in a therapist manual (Clark, 1997) and can also be found in briefer
form in Wells (1997, Chapter 7) and Clark (2001, pp. 419427). The main
steps in treatment were as follow: (a) developing with patients a personal
version of Clark and Wells’s model using their own thoughts, images,
anxiety symptoms, safety behaviors, and attentional strategies; (b) safety
behaviors and self-focused attention experiment: Key safety behaviors
were identified and their adverse effects demonstrated with an experiential
exercise in which patients role-played a difficult social situation while
focusing attention on themselves and using their safety behaviors and then
while focusing attention externally and attempting to drop their safety
behaviors; (c) shifting focus of attention to the social situation: Patients
were encouraged to focus their attention externally to reduce problematic
self-monitoring and to obtain more accurate information about how they
are responded to by other people; (d) video feedback was used to modify
distorted self-imagery: Patients viewed a video of the safety behaviors and
attention experiment and videos of other occasions in which they engaged
in feared social tasks under an instructional set that was designed to make
the discrepancy between patients’ negative, distorted self-images and their
objective social performance particularly evident (see Harvey, Clark,
Ehlers, & Rapee, 2000, for a description and evaluation of this procedure);
(e) behavioral experiments: Extensive use was made of behavioral exper-
iments in which patients specified their feared outcomes for various social
situations and tested out whether they occurred during planned exposure to
the situations using in-session role-plays and in-session and homework-
based in vivo assignments. To maximize disconfirmation, patients were
encouraged to drop safety behaviors and focus their attention externally.
“Widening bandwidth” exercises in which patients intentionally acted
against their excessively rigid rules for social interaction while observing
the consequences were included; (f) problematic anticipatory and
postevent processing was identified: Discussion usually showed that the
disadvantages of anticipatory and postevent processing greatly exceeded its
advantages and, armed with this knowledge, patients were encouraged to
drop it; and (g) dysfunctional assumptions were also identified and mod-
ified by behavioral experiments and by cognitive restructuring techniques.
Sessions were approximately 75 min.
Medication and self-exposure (FLU SE and PLA SE). Patients
who were allocated to medication and self-exposure instructions were
started on identically packaged 20-mg capsules of either fluoxetine or
placebo. Dose was increased to 40 mg in Week 2 or 3. A maximum dose
of 60 mg was permitted. All but 1 patient in each group received the
maximum dose (usually by Week 5 or 6). The remaining 2 patients reached
40 mg (FLU SE) and 20 mg (PLA SE), respectively. At the start of the
trial, patients were informed that they might be asked to provide a blood
sample without advance warning during one of their treatment sessions.
Blood was taken from 16 patients (80%) in each group during a session
between Weeks 9 and 13. An independent laboratory, blind to allocation,
assayed for fluoxetine and norfluoxetine levels. After the blind was broken,
the assays indicated that no patients allocated to placebo had fluoxetine or
its metabolite in their blood. All patients allocated to fluoxetine had
significant blood levels of fluoxetine (M 331.5
g/ml, SD 149.1
g/ml) and norfluoxetine (M 217.7
g/ml, SD 89.8
g/ml). Prior to
starting medication, patients were told that there is good reason to believe
that social phobia is maintained by a neurochemical disturbance that can be
rectified by fluoxetine. They were told that as the dose built up, fluoxetine
should help make them more confident in social situations but that to gain
the maximum benefit from the medication they would also need to sys-
tematically expose themselves to feared social situations, with exposure
being organized in a graded way to progressively build self-confidence.
From Session 3 onward, therapists set several new exposure assignments
each week and reviewed the assignments during the next session. There
were no therapist-accompanied or in-session exposure assignments. Ses-
sions typically lasted 3040 min.
Therapists and Supervision
CT was delivered by four clinical psychologists who were experienced
in the use of CBTs for anxiety. The medication plus self-exposure treat-
ments were delivered by four specialist registrars in psychiatry with several
years of out-patient practice with a mixed caseload that included anxiety
disorders. As do many pharmacotherapists, the psychiatrists had extensive
prior experience with SSRIs but only modest formal training in CBT. All
therapists treated at least two practice social phobia cases in the relevant
treatment modality (CT or medication SE) before the start of the trial.
During the trial, all therapists had regular supervision with David M. Clark
to check protocol adherence and assist with planning future sessions. A
random selection of session tapes was also reviewed. In the medication
conditions, additional supervision from a senior psychiatrist was provided.
No protocol violations were detected.
Measures
Social phobia. Independent assessors rated patients’ fear and avoid-
ance across a range of social situations using the ADIS. The mean rating
across all fear and avoidance items was analyzed. Patients completed five
standardized self-report social phobia scales: Mattick and Clarke’s (1998)
Social Phobia Scale and Social Interaction Anxiety Scale; the LSAS;
Marks and Mathews’s (1979) Fear Questionnaire Social Phobia subscale
(FQ-SOC); and the Fear of Negative Evaluation Scale (Watson & Friend,
1969). To date, the LSAS has most commonly been used as an assessor
rating. However, Baker, Heinrichs, Kim, and Hofman (2002) have recently
provided data that support its use as a self-report instrument. An additional
self-report measure, the Social Phobia Weekly Summary Scale (SPWSS),
which was developed by our group, was also included. The five-item
SPWSS has good internal consistency (Cronbach’s
.81) and consists
of 08 ratings of social anxiety, social avoidance, self-focused versus
external attention, anticipatory processing, and postevent rumination.
General mood. The Beck Anxiety Inventory (BAI; Beck, Epstein,
Brown, & Steer, 1988) and the Beck Depression Inventory (BDI; Beck,
Rush, Shaw, & Emery, 1979) were used to assess anxious and depressed
mood, respectively.
All social phobia and general mood measures were given at each
assessment except for the midtreatment assessment, when the ADIS (as-
sessor rating) and the LSAS (patient self-report) were omitted.
Statistical Analysis
Analyses were intent to treat. All patients who started treatment and
provided at least one postintake assessment were included in the analyses
1060
CLARK ET AL.
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with last available data carried forward, with the exception of the 12-month
follow-up analysis, in which data for patients who failed to reach the
posttreatment assessment were not carried forward.
2
To identify any dif-
ferences between groups before treatment, we compared initial scores for
the three treatment groups with the liberal procedure of separate one-way
analyses of variance (ANOVAs) for each measure. To identify any differ-
ences between groups at midtreatment, posttreatment or follow-up, we
used one-way analyses of covariance (ANCOVAs) with pretreatment
scores as covariates followed by post hoc Duncan’s multiple range tests
when comparing more than two means. We used t tests to identify signif-
icant within-treatment changes. A two-step approach was adopted to deal
with multiple measurement of social phobia. First, a single unweighted
social phobia composite was created and analyzed. Only if the composite
revealed significant between- or within-group differences were further
ANCOVAs or t tests performed on individual social phobia measures. The
composite was generated with the procedure recommended by Rosenthal
and Rosnow (1991) and adopted in several previous trials (e.g., Clark et al.,
1994, 1999; Hollon et al., 1992). Patients’ scores on each (of seven) social
phobia measures were standardized (M 0, SD 1) across pre- and
posttreatment assessments by converting to Z scores. The composite at
each assessment occasion was the mean of the Z scores on that occasion.
Results
Characteristics of Patients
Patients’ mean age was 33.2 years (SD 8.1). Mean duration of
social phobia was 13.3 years (SD 11.3). Fifty-two percent were
women. Fifty percent were married or cohabiting. Seventy-two
percent were employed, 12% were students, and 16% were unem-
ployed. Thirty-three percent left school by age 16, 11% completed
high school, and 56% had some higher education. Forty-three
percent met criteria for avoidant personality disorder. Fourteen
percent were taking psychotropic medication from which they had
to be withdrawn before the start of the trial. There were no
significant differences between the treatment groups in any of
these characteristics.
Dropouts and Number of Sessions Attended
Four patients withdrew before the end of treatment: 2 because of
side-effects (1 in FLU SE, 1 in PLA SE), 1 (PLA SE) to
seek treatment elsewhere, and 1 (PLA SE) relocated for work.
Two further patients (both FLU SE) were withdrawn. One
unexpectedly became pregnant, and the other became severely
depressed and required additional emergency treatment. For these
patients, assessments at the point of withdrawal (Weeks 6, 3, 5, 9,
7, & 12, respectively) were used in the posttreatment and end-of-
booster-period analyses. Patients were offered up to 16 treatment
sessions and 3 booster sessions. For completers, the mean numbers
of sessions attended were CT, 15.1 (SD 1.7) treatment sessions
and 2.5 (SD 0.9) booster sessions; FLU SE, 13.5 (SD 1.8)
treatment sessions and 2.7 (SD 0.9) booster sessions; and
PLA SE, 13.2 (SD 2.8) treatment sessions. For dropouts, the
mean numbers of treatment sessions attended were FLU SE, 6.7
(SD 3.8) and PLA SE, 5.7 (SD 2.5).
Effects of Treatment on Social Phobia
Figure 1 shows the social phobia composite, and Table 1 shows
the individual social phobia measures at each time point. The
social phobia composite was based on seven individual social
phobia measures at all time points except for midtreatment, at
which five individual measures were administered. At pretreat-
ment, one-way ANOVAs indicated that there were no significant
differences between the groups.
At midtreatment (8 weeks), ANCOVA revealed a significant
treatment effect on the social phobia composite. Paired compari-
sons indicated that CT was superior to FLU SE and PLA SE,
which did not differ from each other. Analysis of the five individ-
ual social phobia measures indicated that CT was superior to
FLU SE on two measures and superior to PLA SE on three
measures. Within-group t tests were used to assess pretreatment to
midtreatment change. All three treatments were associated with
significant pretreatment to midtreatment improvement on the so-
cial phobia composite and most individual measures. The mea-
sures that were not significant were the Fear of Negative Evalua-
tion Scale in the FLU SE condition and FQ-SOC and SPWSS in
the PLA SE condition.
At posttreatment (16 weeks), there were significant ANCOVA
treatment effects on the social phobia composite and all seven
individual measures. Paired comparisons indicated that CT was
superior to FLU SE and PLA SE on each measure. FLU
SE did not differ from PLA SE.
3
The t tests indicated that the
CT and FLU SE conditions were associated with significant
pretreatment to posttreatment improvement on the social phobia
composite and all individual measures. PLA SE was associated
with significant pretreatment to posttreatment improvement on all
measures except the FQ-SOC.
2
The main reason for the 12-month follow-up was to determine whether
treatment gains were maintained. In this context, we considered carrying
forward the last observation for patients who did not attend the 12-month
follow-up problematic, as it assumes that such individuals did not relapse.
As a consequence, the extent to which treatment gains were maintained
could be overestimated. At the request of an anonymous reviewer, a
reanalysis of the 12-month follow-up data using the carried forward strat-
egy was also conducted. The results were essentially the same as those
reported in the text. CT remained superior to FLU SE on the social
phobia composite, but the number of individual social phobia measures that
showed a significant difference between the two treatments increased from
four to six. The additional measures were the ADIS and LSAS.
3
A completers-only analysis in which the patients who had less than 16
weeks on medication were excluded produced essentially similar results,
with FLU SE and PLA SE failing to differ on any measure.
Figure 1. Social phobia composite scores at each assessment. CT
cognitive therapy; FLU SE fluoxetine plus self-exposure; PLA
SE placebo plus self-exposure; pre pretreatment, mid midtreat-
ment; post posttreatment; 12m FU 12-month follow-up.
1061
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Table 1
Outcome Measures at Each Assessment
Assessment
Cognitive therapy
Fluoxetine and
self-exposure
a
Placebo and
self-exposure
Group effect
b
n M SD n M SD n M SD
Social phobia composite
Pretreatment 20 0.69 0.69 20 0.49 0.63 20 0.44 0.94 F(2, 57) 0.6
Midtreatment 20 0.54
a
1.02 20 0.05
b
0.97 20 0.08
b
1.11 F(2, 56) 8.4***
Posttreatment 20 1.13
a
0.99 20 0.35
b
1.12 20 0.16
b
1.18 F(2, 56) 9.5***
End of boosters 20 1.27
a
0.83 20 0.56
b
1.14 F(1, 37) 7.7**
12-month follow-up 20 1.28
a
0.86 17 0.68
b
1.01 F(1, 35) 6.4*
Anxiety Disorders Interview Schedule,
Fear and Avoidance
Pretreatment 20 3.37 1.27 20 3.07 1.07 20 3.10 1.38 F(2, 57) 0.4
Posttreatment 20 1.58
a
1.23 19 2.33
b
1.33 20 2.60
b
1.57 F(2, 55) 5.6**
End of boosters 20 1.43 1.15 19 2.01 1.25 F(1, 36) 3.6†
12-month follow-up 20 1.55 1.18 17 2.06 1.24 F(1, 35) 2.3
Social Phobia Scale
Pretreatment 20 30.20 14.79 20 31.33 13.39 20 36.10 18.31 F(2, 57) 0.8
Midtreatment 20 17.44
a
13.24 18 24.39
b
11.48 19 30.42
b
18.00 F(2, 53) 4.1*
Posttreatment 20 10.87
a
11.36 19 21.04
b
14.67 20 27.50
b
18.95 F(2, 55) 6.8**
End of boosters 20 9.80
a
9.51 19 16.05
b
10.51 F(1, 36) 4.6*
12-month follow-up 20 8.90
a
7.57 17 14.59
b
10.69 F(1, 34) 4.2*
Social Interaction Anxiety Scale
Pretreatment 20 48.30 12.26 20 43.85 12.72 20 41.96 14.02 F(2, 57) 1.2
Midtreatment 20 34.02 13.93 18 38.42 13.67 19 35.29 14.67 F(2, 53) 2.8†
Posttreatment 20 24.51
a
13.76 19 32.79
b
15.93 20 33.05
b
14.56 F(2, 55) 5.9**
End of boosters 20 23.73 11.94 20 27.76 15.41 F(1, 37) 2.8†
12-month follow-up 20 23.65
a
14.44 17 29.59
b
13.79 F(1, 34) 4.5*
Liebowitz Social Anxiety Scale
Pretreatment 20 78.65 25.56 20 75.34 17.63 20 71.05 26.67 F(2, 57) 0.5
Posttreatment 20 35.41
a
22.90 19 56.16
b
30.61 20 55.34
b
31.17 F(2, 55) 5.7**
End of boosters 20 31.42
a
23.55 20 52.44
b
32.36 F(1, 37) 6.5*
12-month follow-up 20 34.75 23.21 17 46.46 24.77 F(1, 34) 2.6
Social Phobia Weekly Summary Scale
Pretreatment 20 5.08 1.46 20 4.58 0.93 20 4.66 1.64 F(2, 57) 0.8
Midtreatment 20 2.48
a
1.76 20 3.74
b
1.78 20 3.86
b
2.11 F(2, 56) 6.8**
Posttreatment 20 1.91
a
1.50 20 3.18
b
1.74 20 3.65
b
1.85 F(2, 56) 7.8**
End of boosters 19 1.91
a
1.12 18 2.93
b
1.67 F(1, 34) 5.7*
12-month follow-up 19 1.66
a
1.31 17 2.88
b
1.76 F(1, 33) 7.2*
Fear Questionnaire Social Phobia
Subscale
Pretreatment 20 22.39 6.37 20 19.43 8.28 20 19.00 7.44 F(2, 57) 1.2
Midtreatment 20 14.20
a
7.03 19 15.46
a,b
7.67 19 18.58
b
10.01 F(2, 54) 4.4**
Posttreatment 20 9.20
a
7.26 20 13.60
b
8.01 20 16.25
b
10.26 F(2, 56) 7.6**
End of boosters 20 8.45 6.49 18 10.56 7.63 F(1, 35) 2.8
12-month follow-up 19 8.11 6.43 17 10.94 6.51 F(1, 33) 2.6
Fear of Negative Evaluation
Pretreatment 20 25.16 5.18 20 25.70 5.36 20 23.55 6.92 F(2, 57) 0.7
Midtreatment 20 19.50 8.70 18 23.94 6.01 19 21.16 8.11 F(2, 53) 2.6†
Posttreatment 20 15.28
a
9.00 19 21.31
b
9.24 20 20.30
b
8.11 F(2, 55) 3.8*
End of boosters 20 12.94
a
7.82 18 18.46
b
8.92 F(1, 35) 4.4*
12-month follow-up 19 12.32
a
9.06 17 18.76
b
9.25 F(1, 33) 4.4*
Beck Anxiety Inventory
Pretreatment 20 17.60 9.51 20 17.40 7.42 20 19.75 11.92 F(2, 57) 0.4
Midtreatment 20 7.70 9.53 20 9.15 5.65 20 9.80 8.19 F(2, 56) 0.3
Posttreatment 20 5.50 5.93 20 7.95 7.20 20 9.50 7.32 F(2, 56) 1.6
End of boosters 20 5.05 5.73 18 8.22 6.55 F(1, 35) 3.9†
12-month follow-up 19 4.79
a
3.81 17 7.29
b
4.73 F(1, 33) 4.5*
1062
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Effects of Treatment on General Mood
In contrast to the social phobia measures, ANCOVAs indicated
that the three treatments did not differ in their effects on the
general mood measures (BAI and BDI) at either midtreatment or
posttreatment (see Table 1). However, in all three treatments there
were significant pretreatment to midtreatment and pretreatment to
posttreatment improvements on the BAI and the BDI (all ps
.05).
Maintenance of Treatment Gains
At 16 weeks the medication blind was broken and patients on
placebo were withdrawn from the trial. Patients who had received
CT or FLU SE entered a 3-month booster phase during which
they received up to three additional sessions. Fluoxetine was
maintained at full dose in the booster phase. At the end of the
booster phase, no further treatment sessions were offered and
fluoxetine was gradually withdrawn over a 3- to 6-week period.
End of booster phase. For the social phobia measures,
ANCOVA indicated that CT was superior to FLU SE on the
social phobia composite and four of seven individual social phobia
measures (see Table 1). The t tests comparing posttreatment and
end of booster phase scores were used to determine whether
treatment gains were maintained or improved on in the booster
period. For CT none were significant, indicating that treatment
gains were maintained. For FLU SE significant improvement
was observed in the social phobia composite, t(19) 3.02, p
0.1; the ADIS, t(18) 3.02, p .01; the FQ-SOC, t(17) 2.68,
p .05; and the Social Interaction Anxiety Scale, t(18) 3.66,
p .001. For the general mood measures, ANCOVA indicated
that CT did not differ from FLU SE. The t tests comparing
posttreatment and end of booster scores were nonsignificant, in-
dicating that for both CT and FLU SE treatment gains in general
mood were maintained.
12-month follow-up. For the social phobia measures,
ANCOVA indicated that CT remained superior to FLU SE on
the social phobia composite and four of seven individual social
phobia measures. For both treatments, t tests comparing 12-month
follow-up scores with patients’ scores at posttreatment and at the
end of the booster phase were all nonsignificant, indicating that the
treatment gains were maintained at 12-month follow-up, but there
was no evidence of further, sustained improvement. For the gen-
eral mood measures, CT was superior to FLU SE on the BAI but
not the BDI.
Effect Sizes
To gain a clearer impression of the magnitude of the improve-
ment in social phobia associated with each treatment condition, we
calculated uncontrolled pretreatment to posttreatment, end of
booster, and follow-up effect sizes for the social phobia composite
using the following formula: Effect size (mean social phobia
composite at pretreatment mean social phobia composite at
posttreatment, end of booster, or follow-up) pooled standard
deviation. Table 2 shows the data. Depending on the assessment
point, uncontrolled effect sizes ranged from 2.14 to 2.53 for CT
and from 0.92 to 1.36 for FLU SE. Controlled effect sizes in
which the posttreatment means for CT and FLU SE were
compared with PLA SE were also computed using the following
formula: Controlled effect size (PLA SE posttreatment co-
variance adjusted mean CT or FLU SE posttreatment
Table 2
Effect Sizes for the Social Phobia Composite at Posttreatment,
End of Booster Period, and 12-Month Follow-Up
Assessment CT FLU SE PLA SE
Posttreatment 2.14 0.92 0.56
End of booster period 2.57 1.14
12-month follow-up 2.53 1.36
Note. CT cognitive therapy; FLU SE fluoxetine plus self-
exposure; PLA SE placebo plus self-exposure. Effect size (mean
composite at pretreatment minus mean composite at posttreatment, end of
booster or at follow-up) pooled standard deviation.
Table 1 (continued)
Assessment
Cognitive therapy
Fluoxetine and
self-exposure
a
Placebo and
self-exposure
Group effect
b
n M SD n M SD n M SD
Beck Depression Inventory
Pretreatment 20 13.25 7.48 20 12.75 6.98 20 12.69 8.07 F(2, 57) 0.1
Midtreatment 20 6.95 7.60 20 8.60 7.12 20 8.00 8.34 F(2, 56) 0.5
Posttreatment 20 4.70 5.60 20 7.70 7.64 20 7.90 8.57 F(2, 56) 1.9
End of boosters 20 4.45 5.19 18 6.61 5.97 F(1, 35) 2.6
12-month follow-up 19 4.53 3.99 17 5.65 5.27 F(1, 33) 0.8
Note. Within an assessment occasion, means with no subscripts and those that share the same subscript do not differ. Means with nonoverlapping
subscripts differ at p .05 or better.
a
Two fluoxetine and self-exposure patients restarted fluoxetine between the end of the booster period and the 12-month follow-up. Patients were asked to
refrain from seeking any additional nontrial treatment during the follow-up period. No cognitive therapy patient had additional trial or nontrial treatment.
Two fluoxetine and self-exposure patients started a course of psychological treatment between the end of the booster period and the 12-month follow-up.
Both had a full assessment, data from which were used for the 12-month follow-up analysis, before starting the additional treatment.
b
At pretreatment, group effect was based on one-way analysis of variance. At all other assessment points group effect was based on one-way analysis of
covariance, with pretreatment scores as the covariate. Significant (p .01) analysis of variance or analysis of covariance main effects were investigated
with post hoc Duncan’s multiple range tests when more than two means were involved.
p .1. * p .05. ** p .01. *** p .001.
1063
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covariance-adjusted mean) pooled standard deviation. Cohen
(1988) proposed a threefold classification of effect sizes: small
(0.200.49), medium (0.500.79), and large (0.80 and above).
According to this system, the posttreatment controlled effect size
for CT (1.31) is large, and the posttreatment controlled effect size
for FLU SE (0.21) is small.
Predictors of Treatment Response
Multiple regression was used to identify possible predictors of
treatment response in the total sample. Six possible predictors
(initial level of depression, duration of social phobia, and presence
of avoidant personality disorder and patient age, gender, and
marital status) were entered, with the dependent variable being the
social phobia composite residualized gain scores at posttreatment.
None of the predictors were significant.
Equivalence Analysis for FLU SE Versus PLA SE
To investigate the apparent lack of difference between FLU
SE and PLA SE, we conducted an equivalence analysis (see
Rogers, Howard, & Vessey, 1993) on the social phobia composite
data for the two medication conditions. Equivalence analysis al-
lows one to further explore a null result by calculating the largest
possible difference between two conditions that a study may have
missed because of limitations of statistical power. Setting alpha at
.05 and using equivalence analysis, we reject the hypothesis that
FLU SE has a posttreatment adjusted mean on the social phobia
composite that is more than 0.70 superior to that for PLA SE.
However, we are not able to reject the hypothesis that FLU SE
is more effective than PLA SE but the difference is less than
0.70. If we convert this calculation into controlled effect sizes, our
sample size does not allow us to reject the hypothesis that, com-
pared with the PLA SE control condition, FLU SE has a
positive effect size of up to 0.56 (a medium effect size in Cohen’s
classification).
Discussion
Effectiveness of Cognitive Therapy
The overall pattern of results indicates that CT is an effective
treatment for generalized social phobia. Patients treated with CT
improved significantly more than patients who received self-
exposure instructions combined with fluoxetine or placebo. In
addition, the gains obtained in treatment were well maintained at
1-year follow-up.
In line with routine clinical practice, CT sessions were longer
than medication plus self-exposure sessions. This raises the pos-
sibility that the superiority of CT could have been due to greater
therapist contact. A further trial with a control treatment involving
an identical amount of therapist contact is required to definitively
address this question. However, there are two reasons for suppos-
ing that therapist contact alone is unlikely to explain the superi-
ority of CT. First, in a recent social phobia trial, Heimberg et al.
(1998) found that 150-min sessions of education and support were
no more effective than 30-min sessions devoted to administering a
pill placebo, and both conditions were inferior to 150-min sessions
of CBGT. Second, therapy experiments that attempt to assess the
short-term impact of discrete therapy maneuvers have shown that
several of the procedures involved in the CT program (dropping
safety behaviors, shifting to an external focus of attention, and
using video feedback) have beneficial effects over and above those
obtained with a similar duration control procedure (Harvey et al.,
2000; Morgan & Raffles, 1999; Wells et al., 1995; Wells &
Papageorgiou, 1988).
Meta-analyses of other CBTs for social phobia (Fedoroff &
Taylor, 2001; Feske & Chambless, 1995; Gould et al., 1997;
Taylor, 1996) have reported mean pretreatment to posttreatment
effect sizes between 0.80 and 1.08 for social phobia measures. In
trials that have focused exclusively on generalized social phobia
(Hope, Herbert, & White, 1995; Salaberria & Echeburua, 1998;
Scholing & Emmelkamp, 1993), CBT pretreatment to posttreat-
ment effect sizes on the social phobia measures that were used in
the current trial have ranged from 0.56 to 1.31. The pretreatment
to posttreatment effect size observed with CT in the current trial
(2.14) is substantially larger, which raises the possibility that the
new CT program has enhanced efficacy. However, comparisons
between trials are fraught with difficulty because of differences in
selection criteria, patient demographics, and other characteristics.
For this reason, a within-trial comparison between CT and other
established behavioral and cognitive–behavioral programs is
required.
Effectiveness of Medication Plus Self-Exposure
Patients who received medication plus self-exposure showed
significant and substantial improvements on almost all social pho-
bia measures between pretreatment and posttreatment. The im-
provement observed with PLA SE was not surprising given the
established efficacy of self-exposure in phobic disorders. At the
time the trial was planned, five open trials (Black et al., 1992;
Koponen et al., 1995; Perugi et al., 1994; Schneier et al., 1992;
Van Ameringen et al., 1993) suggested that fluoxetine is effective.
Since the start of the trial, several randomized controlled trials
establishing the effectiveness of other SSRIs have been published.
Given these points, we were surprised to find that FLU SE was
not more effective than PLA SE. This finding cannot be attrib-
uted to inadequate dosage, as almost everyone was prescribed the
maximum of 60 mg and plasma analysis indicated excellent com-
pliance, with all patients in the fluoxetine condition having suitable
blood levels of fluoxetine and its metabolite (norfluoxetine). There
are at least three other (possibly interacting) explanations for the
lack of difference between FLU SE and PLA SE.
First, the present trial is underpowered relative to most recent
medication trials that routinely have larger cell sizes. Our
equivalence-testing analysis indicated that with our cell size of 20
patients, a difference between FLU SE and PLA SE equiv-
alent to a medium controlled effect size (Cohen, 1988), could have
been missed. Since the completion of the trial, two other groups
have reported fluoxetine versus placebo comparisons. The results
obtained by these two groups are consistent with the reduced
power argument. In a published study using cell sizes of 30 per
group, Kobak, Greist, Jefferson, and Katzelnick (2002) failed to
find a significant difference between fluoxetine and placebo. By
contrast, in a conference paper, Huppert, Roth, Keefe, Davidson,
and Foa (2002) reported obtaining some significant differences
between fluoxetine and placebo when a larger cell size (approxi-
mately 60 patients per group) was used.
1064
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Second, fluoxetine may be less effective in social phobia than
the three other SSRIs (fluvoxamine, sertraline, paroxetine) that
have been shown to be effective in randomized controlled trials.
Consistent with this suggestion, the controlled effect sizes ob-
served with fluoxetine in the present trial and in Kobak et al.’s
(2002) trial are generally lower than those reported in trials of the
other SSRIs (see Fedoroff & Taylor, 2001; Gould et al., 1997). A
trial involving a direct comparison between fluoxetine and the
other SSRIs is required to clarify this point. If fluoxetine does turn
out to be less effective, the finding may be an important lead in
helping clarify the neurobiology of social anxiety. For example,
fluoxetine differs from fluvoxamine, sertraline, and paroxetine in
the relative balance of its noradrenergic and serotinergic effects
(Leonard, 1996; Stahl, 1998).
Third, the fluoxetine versus placebo contrast in the present trial
may have been shorter than ideal. Kobak et al.’s (2002) main
contrast was after 14 weeks and ours was after 16 weeks. How-
ever, patients in the present trial who stayed on fluoxetine after the
medication blind was broken (at 16 weeks) showed further signif-
icant improvement between that point and the end of the booster
period (28 weeks). It is therefore possible that a significant differ-
ence between fluoxetine and placebo might have emerged between
16 and 28 weeks.
The present trial was relatively unusual in combining medica-
tion with self-exposure. Only two previous social phobia medica-
tion trials (Blomhoff et al., 2001; Gelernter et al., 1991) have had
a similar design. However, it seems unlikely that adding self-
exposure contributed to lack of difference between fluoxetine and
placebo, as Kobak et al. (2002) did not use self-exposure and still
failed to find a significant difference between fluoxetine and
placebo.
Contrast Between Social Phobia and General Mood
Measures
In contrast to the results obtained with standardized measures of
social phobia, at posttreatment there were no significant between-
group differences on the two general mood measures (BDI and
BAI). The substantial improvements in depression that were ob-
served with all three treatments are consistent with the view that
much of the depressed mood observed in our patients was second-
ary to their social phobia. This is perhaps not surprising when one
recalls that patients with concurrent major depressive disorder
were excluded from the study. The observed lack of difference
between the three treatments on the BDI in our sample could be
viewed as an indication of the treatments’ particularly specific
effects on social phobia or it could be the consequence of a floor
effect. Consistent with the latter suggestion, in all three treatments
the posttreatment means for the BDI were in the nonclinical range.
Similarly to the BDI, the BAI showed substantial but broadly
similar improvement in all three treatments, with CT differing
from FLU SE only at the 12-month follow-up. Posttreatment
means for the BAI were in the minimal or mild anxiety range
(Beck & Steer, 1993), suggesting a floor effect on this measure as
well. In addition, the BAI may have relatively poor sensitivity as
an outcome measure in phobic disorders because the extensive
avoidance of feared situations shown by severe phobics can result
in low pretreatment scores on general measures of anxious mood
such as the BAI.
Stability of Therapeutic Gains
In CT and FLU SE the improvements obtained at the end of
treatment were maintained at 1-year follow-up. The CT finding is
in line with other CBT research (see Fedoroff & Taylor, 2001;
Taylor, 1996). For medications, some studies (e.g., Liebowitz et
al., 1999) have shown an increased relapse rate following discon-
tinuation. It is encouraging that this did not happen in the present
study, perhaps because medication was combined with self-
exposure. Further studies could explore this issue by comparing
long-term outcome of medication alone versus medication plus
self-exposure.
Limitations
Four limitations need to be borne in mind when interpreting the
study. First, as mentioned above, the sample size for a drug–
placebo comparison was relatively modest, and a medium size
active medication effect could have been missed. Second, it is
possible that fluoxetine is less effective than some other SSRIs
and, as a consequence, one cannot assume that the observed
difference between CT and FLU SE would generalize to other
SSRIs. Third, the exposure element in the medication SE groups
was less extensive than in most formal exposure programs. There
were no therapist-assisted or in-session exposure exercises. In
addition, as do many pharmacotherapists, the psychiatrists who
delivered the medication treatments had little previous formal
training in CBT. It is possible that both fluoxetine and placebo
would have been associated with greater improvement if they had
been combined with a more extensive exposure program delivered
by therapists with specialized training in CBT. Fourth, it is unclear
whether the results can be generalized to patients with specific
social phobia or to patients with generalized social phobia and
concurrent major depression, as both types of patient were ex-
cluded from the study. Specific social phobia was excluded be-
cause it is generally less disabling and was also considered less
likely to respond to medication, but no studies have formally tested
this suggestion. Comorbid major depression was excluded to en-
sure that any medication effect was not an indirect consequence of
treating depression rather than a direct effect on social phobia.
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Received July 1, 2002
Revision received March 10, 2003
Accepted March 11, 2003
1067
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