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Exposure Therapy and Sertraline in Social Phobia 1 Year Follow Up of A Randomised Controlled Trial
Exposure Therapy and Sertraline in Social Phobia 1 Year Follow Up of A Randomised Controlled Trial
Exposure therapy and sertraline in social phobia: centres in Norway and Sweden (n (n¼289)
289)
and from advertisements in newspapers
and other media (n (n¼159).
159). Three hundred
1-year follow-up of a randomised controlled trial and seventy-five patients were randomly
assigned by a computer to receive double-
TONE TANGEN HAUG, SVEIN BLOMHOFF, KERSTIN HELLSTRM,
blind sertraline or placebo in blocks of
INGAR HOLME, MATS HUMBLE, HANS PET TER MADSBU and JAN EGIL WOLD eight, so that four patients in each block
were randomised to each treatment. No
other stratification factor was used. Each
block was assigned to a specific general
practitioner. In both the sertraline and the
placebo groups half of the patients were
Background Maintenance of The short-term effect of treatment of social randomly allocated to exposure therapy or
treatment effect is important for the phobia has been demonstrated in several to general medical care only. A separate
studies, and both cognitive–behavioural randomisation list was made for exposure
choice of treatment for social phobia.
treatments and pharmacological inter- or non-exposure treatment. Sealed envel-
Aims To examine the effect of exposure ventions have given positive findings opes for allocations from this list were kept
(Mattick et al, al, 1989; Gelernter et al, al, by the investigators and opened after in-
therapy and sertraline 28 weeks after
1991; Liebowitz et al, al, 1992; Versiani et clusion of the patient into the study. During
cessation of medical treatment. al,
al, 1992; Davidson et al, al, 1993; Heimberg this procedure equal numbers of partici-
et al,
al, 1993; Van Vlet et al,
al, 1994; Katzelnick pants were assigned to each treatment
Method In this study 375 patients with option in each block. Tablets were pack-
et al,
al, 1995; Taylor, 1996; Stein et al,
al, 1998).
social phobia were randomised to The studies vary widely in terms of out- aged and numbered by the sponsor and
treatment with sertraline or placebo for come measures, type of control groups, personally delivered to each investigator.
24 weeks, with or withoutthe addition of sample selections and whether treatment is Participants were evaluated at week 24
offered individually or in groups, making (post-treatment, n¼346)346) and at week 52
exposure therapy.Fifty-two weeks after
it impossible to draw meaningful compari- (follow-up, n¼328;
328; Fig. 1). Of the original
inclusion, 328 patients were evaluated by sons between studies. A few studies have 375 participants, 228 were female and
the same psychometric tests as at baseline compared the effect of psychological treat- 147 were male; their mean age was 39.8
and the end of treatment (24 weeks). ment with the effect of medication (Turner (s.d.¼10.4)
(s.d. 10.4) years. Mean age at symptom
et al,
al, 1994; Heimberg et al, al, 1998), but it onset was 16.2 (s.d.¼9.1)
(s.d. 9.1) years and the
Results The exposure therapy group has been difficult to identify treatments that mean duration of illness was 23.6 (s.d.¼(s.d.
and the placebo group had a further are clearly superior to others. Which form 12.2) years. Patients with comorbid dys-
of treatment is chosen will therefore mainly thymia or specific phobias were allowed
improvement in scores on social phobia
depend on the patient’s preferences and the to enter the study; those with panic disorder
during follow-up: mean change in the availability of services. However, the main- with onset before social phobia or any
Clinical Global Impression ^ Social tenance of treatment effects after cessation other current anxiety or major depressive
Phobia overall severity score was of active treatment is also important in this disorder, substance misuse or an eating dis-
0.45 (95% CI 0.16^0.65, P50.01) decision. order were not eligible. In addition, pa-
In this study we examine the effect on tients with a lifetime history of bipolar
for the exposure group, and 0.25
generalised social phobia of 24 weeks of disorder or psychosis were excluded. A co-
(95% CI 0.00^0.48, P50.05) for the treatment with sertraline, with or without morbid psychiatric disorder was diagnosed
placebo group. At week 52 the sertraline the addition of exposure therapy, 1 year in 133 (35%) patients; 101 (27%) had
plus exposure group and the sertraline- after the start of treatment. phobic anxiety disorder, 6 (1.6%) panic
alone group had a significant deterioration disorder, 6 (1.6%) dysthymia and 20
(5.3%) other diagnoses.
onthe 36 -item Short Form Health Survey
METHOD All patients were scheduled for nine
compared with exposure alone. meetings with the investigator during the
People aged 18–65 years with generalised first 16 weeks of treatment and a final
Conclusions Exposure therapy alone social phobia according to DSM–IV criteria efficacy assessment after 24 weeks. The
yielded a further improvement during (American Psychiatric Association, 1994) patients were randomised to four treatment
follow-up, whereas exposure therapy of at least 1 year’s duration and rated groups and treated by general practitioners
combined with sertraline and sertraline as moderately ill (a score of at least 4) on for 24 weeks with sertraline or a pill
the overall severity item of the severity placebo, combined with 12 weeks of expo-
alone showed a tendency towards
sub-scale of the Clinical Global Impression sure therapy or of only general medical
deterioration after the completion of – Social Phobia scale (CGI–SP, range 1–7, care. Exposure therapy was given in eight
treatment. Davidson et al,
al, 1993) were eligible for in- sessions for the first 12 weeks of treatment.
clusion in the study. Participants were con- Each of the sessions had an estimated dura-
Declaration of interest Funding was secutively recruited from people seeking tion of 15–20 min. In the first sessions,
provided by Pfizer,Inc. medical care at 41 different primary care main problem areas were identified and
31 2
Instruments
The Mini International Neuropsychiatric
Interview (MINI–R; Sheehan et al, al, 1994)
was used to assess DSM–IV psychiatric
diagnoses. The Clinical Global Impression
Severity Scale (CGI–SP; Liebowitz, 1992)
the Social Phobia Scale (SPS; Mattick &
Clark, 1998), the Fear of Negative
Evaluation (FNE) scale (Watson & Friend,
1969) and the Marks Fear Questionnaire
(MFQ, Marks & Matthews, 1979) assessed
the degree of social phobia. The Sheehan
Disability Inventory (SDI; Leon et al, al,
1992) and the mental health sub-scale of
the MOS 36-item Short Form Health
Survey (SF–36; McHorney et al, al, 1993) as-
sessed daily functioning. The Montgomery–
Åsberg
Asberg Depression Rating Scale (MADRS;
Montgomery & Åsberg,
Asberg, 1979) assessed de-
gree of depression. Patients were also asked
about their employment, sick leave and
medical symptoms during the preceding
year.
Statistical procedures
The program SAS version 6.12 for Win-
dows (SAS Institute, 1997) was employed
in all analyses. All efficacy analyses were
on the intention-to-treat patient popu-
lation: this population was defined as those
who received at least one dose of medi-
cation and at least one efficacy evaluation
post-baseline. All statistical tests were
Fig. 1 Trial profile. two-tailed with a¼0.05. 0.05. Sample size
calculation was based on an estimated
agreement was reached about homework (w2¼12.32,
12.32, P50.001) and sertraline alone 20% difference between active drug and
assignments. In the remaining sessions, the (w2¼10.13,
10.13, P¼0.002)
0.002) were significantly placebo. This required a sample size of at
patients were instructed to gradually superior to placebo. Trends towards least 340 patients to detect a significant
expose themselves to feared situations, increased efficacy of exposure alone difference if b¼0.10
0.10 and the drop-out rate
and to keep exposure homework diaries. compared with placebo (P (P¼0.083)
0.083) and is 35%. This procedure made the study
Details of the exposure therapy have been combined sertraline and exposure primarily powered for analyses of sertraline
published elsewhere (Haug et al, al, 2000). compared with exposure alone (P (P¼0.059)
0.059) v. non-sertraline and exposure v. non-
At week 24, patients treated with sertraline were also observed. More-detailed results exposure, but allowed also pairwise com-
were significantly more improved than have been presented in an earlier paper parisons between the treatment groups. In
those who did not receive sertraline (Blomhoff et al, al, 2001). One year after the latter analyses, however, the power
(w2¼12.53,
12.53, P50.001; OR¼0.534,
OR 0.534, 95% inclusion, all patients were asked to was reduced and the risk of false-negative
CI 0.347–0.835). No significant difference participate in a follow-up assessment (week results increased. Repeated-measures analy-
was observed between those who received 52). Those who had not improved satisfac- sis of covariance for each scale measure-
exposure therapy and those who did not torily at the end of week 24 could be ment at 24 weeks and 52 weeks was done
(w2¼2.18,
2.18, P¼0.140;
0.140; OR¼0.732,
OR 0.732, 95% offered further treatment during the to test differences between treatment
CI 0.475–1.134). In the pairwise compari- follow-up period – either psychological groups globally, adjusted for baseline
sons, combined sertraline and exposure treatment or medication, as decided by the values at week 0. Multiple ordinal logistic
313
T
Table
able 1 Change in scores on the Clinical Global Impression ^ Social Phobia (CGI^SP) severity sub-scale and the Social Phobia Scale (SPS) from week 24 to week 52
(n¼82)
Placebo (n 82) (n¼83)
Sertraline+exposure (n 83) (n¼85)
Sertraline (n 85) (n¼78)
Exposure+placebo (n 78)
CGI^SP severity
Anxiety attacks (70.02 to 0.50)
0.26 (7 70.01 (7
(70.23 to 0.21) 70.05 (7
(70.28 to 1.19) (70.14 to 0.39)
0.14 (7
Avoidance (70.04 to 0.47)
0.22 (7 70.05 (7
(70.31 to 0.21) (70.25 to 0.30)
0.05 (7 (70.10 to 0.45)
0.17 (7
Performance anxiety 0.36* (0.05 to 0.56) 70.04 (7
(70.24 to 0.15) 70.13 (7
(70.37 to 0.13) (70.12 to 0.40)
0.14 (7
Disability 0.32** (0.08 to 0.53) 70.05 (7
(70.27 to 0.18) (70.19 to 0.36)
0.12 (7 0.32** (0.06 to 0.52)
Overall severity 0.25* (0.00 to 0.48) (70.23 to 0.23)
0.00 (7 (70.17 to 0.33)
0.10 (7 0.45** (0.16 to 0.65)
SPS (70.61 to 3.93)
1.66 (7 (71.42 to 2.25)
0.42 (7 70.18 (7
(72.18 to 1.82) 3.86** (1.27 to 5.64)
regression was also used to identify any in scores on the CGI–SP overall severity P50.01), FNE (mean change 2.36, 95%
statistical interaction between treatment sub-scale (mean change 0.45, 95% CI CI 0.97–3.77, P50.01) and SF–36 (mean
groups on response. Pairwise comparisons 0.16–0.65, P50.01) and disability sub- change 1.34, 95% CI 0.89–1.85, P50.01)
for changes from week 24 to week 52, scale (mean change 0.32, 95% CI 0.06– between week 24 and week 52. The
adjusted for baseline, were made between 0.52, P50.01), and on the SPS (mean placebo-only group had a significant
each of the three active-treatment groups change 3.86, 95% CI 1.27–5.64, P50.01) improvement on the Brief Social Phobia
and the placebo-only group. At each during follow-up. The placebo-only group Scale fear sub-scale (mean change 1.01,
time point (24 weeks and 52 weeks) in the also had a significant improvement on 95% CI 0.03–2.00, P50.05), MFQ (mean
time point analyses all groups were com- the CGI–SP overall severity sub-scale change 3.48, 95% CI 1.12–5.83,
pared pairwise, with Bonferroni P-value (mean change 0.25, 95% CI 0.00–0.48, P50.01), FNE (mean change 1.29, 95%
adjustments for each scale analysed. P50.05), disability sub-scale (mean change CI 0.92–2.65, P50.05), SDI work sub-
0.32, 95% CI 0.08–0.53, P50.01) and scale (mean change 1.07, 95% CI 0.44–
RESULTS performance sub-scales (mean change 1.69, P50.01), SDI social sub-scale (mean
0.36, 95% CI 0.05–0.56, P50.05). For change 0.91, 95% CI 0.27–1.54, P50.05)
Of the 375 patients assessed at baseline, the sertraline plus exposure and the and the SF–36 (mean change 1.51, 95%
346 had a post-therapy assessment at week sertraline-alone groups there was a slight CI 1.01–2.45, P50.01). For the sertraline
24, and 328 a follow-up assessment at week deterioration in scores on most of the CGI plus exposure and the sertraline-alone
52. Only 18 patients were lost to follow-up sub-scales and on SPS, but the changes were groups there was a deterioration in scores
between week 24 and week 52. The main not significant (Table 1, Fig. 2). on SF–36 between week 24 and week 52
reasons for patients dropping out were the The exposure-alone group had also a (mean change 70.89, 95% CI 71.35 to
lack of perceived need for further treat- significant improvement on the fear and 1.34, P50.05; 71.40, 95% CI 71.90 to
ment, events unrelated to treatment such avoidance sub-scales of the Brief Social 1.92, P50.01, respectively). Other changes
as moving to another area, or unknown Phobia Scale (mean changes 1.01, 95% CI were not significant (Table 2, Figs 3
reasons (Fig. 1). 0.06–1.96, P50.05, and 1.07, 95% CI and 4).
0.01–2.14, P50.05, respectively), MFQ Compared with the placebo group,
(mean change 3.46, 95% CI 1.27–5.64, the sertraline-alone group were found to
Changes in psychometric scores
have a significant deterioration on the
from baseline to week 52
CGI–SP performance anxiety sub-scale
All four study groups had a significant (mean difference in change 0.54, 95% CI
reduction in scores on CGI–SP (all sub- 0.13–0.96, P¼0.05),
0.05), MFQ (mean differ-
scales), SPS, Brief Social Phobia Scale (all ence in change 4.84, 95% CI 0.95–8.74,
sub-scales; Davidson et al,al, 1991), MFQ P¼0.01),
0.01), FNE (mean difference in change
and FNE (P(P50.001) from baseline to week 2.34, 95% CI 0.15–4.54, P¼0.03) 0.03) and
52. There were also significant reductions SF–36 (mean difference in change 72.92,
in MADRS score and in scores on the SDI 95% CI 74.67 to 71.17, P50.01). There
and SF–36. was also a significant deterioration in ser-
Fig. 2 Mean scores on the Clinical Global Impres- traline compared with exposure on MFQ
Changes in psychometric scores sion ^ Social Phobia overall severity sub-scale at (mean difference in change 4.10, 95% CI
from week 24 to week 52 baseline week 24 and week 52 (range 0 ^7). 0.17–8.03, P¼0.03),
0.03), FNE (mean difference
Participants who had been treated with ex- ^, placebo; &, sertraline + exposure; ~, exposure; in change 3.00, 95% CI 0.78–5.22,
posure alone had a significant improvement 6
6, sertraline. P50.01) and SF–36 (mean difference in
314
T
Table
able 2 Change in scores1 on the Brief Social Phobia Scale (BSPS), the Fear of Negative Evaluation (FNE) scale, the Marks Fear Questionnaire (MFQ), the Sheehan
(n¼328)
Disability Inventory (SDI), and the mental health sub-scale of the 36-item Short Form Health Survey (SF^36) from week 24 to week 52 (n 328)
(n¼82)
Placebo (n 82) (n¼83)
Sertraline+exposure (n 83) (n¼85)
Sertraline (n 85) (n¼78)
Exposure+placebo (n 78)
BSPS
Fear 1.01* (0.03 to 2.00) (70.84 to 1.00)
0.08 (7 (70.84 to 1.27)
0.21 (7 1.01* (0.06 to 1.96)
Somatic reaction (70.54 to 0.66)
0.06 (7 70.40 (7
(70.93 to 0.13) (70.55 to 0.76)
0.11 (7 (70.44 to 0.54)
0.05 (7
Avoidance (70.24 to 1.71)
0.74 (7 (70.77 to 0.94)
0.09 (7 (70.31 to 1.68)
0.68 (7 1.07* (0.01 to 2.14)
MFQ 3.48** (1.12 to 5.83) (71.80 to 2.14)
0.17 (7 71.27 (7
(73.57 to 1.02) 3.46** (1.27 to 5.64)
FNE 1.29* (0.02 to 2.56) (70.96 to 1.62)
0.33 (7 70.34 (7
(71.49 to 0.81) 2.36** (0.96 to 3.77)
SDI
Work 1.07** (0.44 to 1.69) 70.03 (7
(70.51 to 0.46) 70.11 (7
(70.57 to 0.34) (70.29 to 1.05)
0.38 (7
Social 0.91* (0.27 to 1.54) 70.18 (7
(70.68 to 0.31) (70.44 to 0.59)
0.08 (7 (70.08 to 1.36)
0.64 (7
Family (70.10 to 1.02)
0.46 (7 70.09 (7
(70.45 to 0.26) 70.05 (7
(70.50 to 0.40) (70.31 to 0.63)
0.16 (7
SF^36 1.51** (1.01 to 2.45) 70.89* (7
(71.35 to 1.34) 71.40** (7
(71.90 to 1.92) 1.34** (0.89 to 1.85)
1. All scales patient-rated. Score ranges: BSPS fear and avoidance sub-scales 0 ^28, somatic reaction sub-scale 0 ^16; FNE 0 ^30, MFQ 0 ^ 40, SDI 0 ^10, SF^35 0 ^100.
2. Negative values indicate deterioration.
*P50.05, **P**P50.01.
31 5
Mean (s.e.)
Mean (s.e.) Difference from placebo Mean (s.e.) Difference from placebo Mean (s.e.) Difference from placebo
CGI^SP severity
Anxiety 70.29 (0.13) 70.05 (0.13) 0.24 (7
(70.19 to 0.66) 0.414 0.04 (0.12) 0.33 (7
(70.09 to 0.75) 0.156 70.13 (0.13) 0.16 (7
(70.27 to 0.58) 0.722
Avoidance 70.22 (0.13) 70.01 (0.13) 0.22 (7
(70.23 to 0.56) 0.519 70.06 (0.13) 0.16 (7
(70.28 to 0.60) 0.719 70.14 (0.14) 0.08 (7
(70.38 to 0.53) 0.948
Performance 70.39 (0.12) 70.01 (0.12) 0.39 (7
(70.03 to 0.80) 0.074 0.15 (0.12) 0.54 (0.13 to 0.96) 0.005 0.09 (0.13) 0.31 (7
(70.12 to 0.73) 0.209
anxiety
Disability 70.35 (0.13) 0.00 (0.13) 0.35 (7
(70.07 to 0.77) 0.125 70.12 (0.12) 0.23 (7
(70.19 to 0.65) 0.425 70.31 (0.13) 0.04 (7
(70.39 to 0.46) 0.994
Overall severity 70.25 (0.112) 70.05 (1.12) 0.20 (7
(70.21 to 0.62) 0.514 70.10 (0.12) 0.16 (7
(70.26 to 0.57) 0.702 70.43 (0.13) 70.18 (7
(70.06 to 0.24) 0.632
SPS 72.03 (1.08) 71.46 (1.07) 0.57 (7
(73.02 to 4.16) 0.966 70.31 (1.05) 1.72 (7
(71.82 to 5.27) 0.522 73.26 (1.10) 71.23 (7
(74.87 to 2.40) 0.762
BSPS
Fear 71.17 (0.50) 70.40 (0.51) 0.77 (7
(70.92 to 2.46) 0.571 70.18 (0.50) 0.99 (7
(70.68 to 2.66) 0.363 71.02 (0.52) 0.16 (7
(71.55 to 1.86) 0.993
Somatic reaction 70.10 (0.29) 0.19 (0.30) 0.29 (7
(70.69 to 1.28) 0.828 70.06 (0.29) 0.04 (7
(70.93 to 1.01) 0.999 70.06 (0.30) 0.04 (7
(70.95 to 1.03) 0.999
Avoidance 70.83 (0.50) 70.41 (0.50) 0.43 (7
(71.24 to 2.09) 0.879 70.77 (0.49) 0.06 (7
(71.59 to 1.71) 0.999 70.99 (0.51) 70.15 (7
(71.84 to 1.53) 0.993
MFQ 74.22 (1.18) 72.01 (1.19) 2.22 (7
(71.75 to 6.18) 0.411 0.62 (1.15) 4.84 (0.95 to 8.74) 0.010 73.48 (1.20) 0.74 (7
(73.23 to 4.72) 0.946
FNE 71.58 (0.66) 71.09 (0.67) 0.49 (7
(71.72 to 2.71) 0.915 0.76 (0.65) 2.34 (0.15 to 4.54) 0.033 72.24 (0.68) 70.66 (7
(72.89 to 1.58) 0.830
SDI
Work 70.97 (0.29) 70.08 (0.29) 0.88 (7
(70.09 to 1.86) 0.084 70.15 (0.28) 0.82 (7
(70.14 to 1.78) 0.113 70.32 (0.30) 0.64 (7
(70.34 to 1.63) 0.286
Social 70.88 (0.30) 70.02 (0.30) 0.86 (0.09 to 1.86) 0.084 70.05 (0.29) 0.83 (7
(70.16 to 1.83) 0.121 70.64 (0.31) 0.24 (7
(70.78 to 1.25) 0.903
Family 70.23 (0.23) 0.02 (0.23) 0.25 (7
(70.52 to 1.02) 0.782 0.07 (0.23) 0.30 (7
(70.47 to 1.06) 0.679 70.29 (0.24) 70.06 (7
(70.84 to 0.72) 0.996
SF^36 1.51 (0.53) 70.89 (0.53) 72.40 (7
(74.17 to 0.63) 0.004 71.40 (7
(70.52) 72.92 (7
(74.67 to 1.17) 50.001 1.34 (0.54) 70.18 (7
(71.97 to 1.61) 0.991
1. All scales patient-rated. Score ranges: BSPS fear and avoidance sub-scales 0 to 28, somatic reaction sub-scale 0 ^16; FNE 0 ^30, MFQ 0 ^ 40, SDI 0 ^10, SF^36 0 ^100.
LON G -T E R M E F F E C T S OF S O C I A L P HOB
HO B I A T H E R A P Y
317
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