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Abstract

Objective: This is a naturalistic treatment outcome study investigating the impact of preexisting antidepressant use on the effectiveness of group cognitive behaviour therapy (CBT) for social phobia.

Method: Of the 133 participants who completed the CBT program, 49 reported taking antidepressants (CBT ++ AD group), while 84 reported not taking antidepressants (CBT group). The treatment program involves 40 h of structured, group-based CBT over 7 weeks. The dependent measures included the Social Phobia Scale and Social Interaction Anxiety Scale, the Fear of Negative Evaluation Scale, the Depression, Anxiety and Stress Scale and the Short Form-12.

Results: Both the CBT ++ AD group and the CBT group improved significantly across treatment on all dependent measures. There were no significant differences between the groups on any outcome measure and the rate of improvement from pre- to post-treatment for both groups did not differ.

Conclusions: Pre-existing antidepressants did not significantly enhance or detract from the positive treatment outcome of a structured, group-based CBT program for social phobia.

Keywords

antidepressant medication cognitive behaviour therapy social phobia treatment outcome

Social phobia is an anxiety disorder characterized by a marked and persistent fear of one or more social or performance situations involving potential scrutiny by others and possible embarrassment or humiliation [1]. It is a prevalent and disabling disorder [2–4], with a high rate of comorbid depression, other anxiety disorders and substance use disorders [5]. It is a challenging anxiety disorder to treat, particularly at the severe end of the social phobia spectrum [6–8].

In terms of pharmacological treatments for social phobia, antidepressants are increasingly being regarded as an effective option, at least in the short term [9], [10]. The main medication classes demonstrating superiority to placebo in controlled trials of social phobia are the monoamine oxidase inhibitors (MAOIs) and the serotoninspecific re-uptake inhibitors (SSRIs). Of the MAOIs, phenelzine has been the most extensively studied in the treatment of social phobia, and has demonstrated greater effectiveness than placebo in a number of controlled trials [11], [12]. Use of the MAOIs, however, is limited by serious side-effects that include potentially fatal interactions [13]. The reversible monoamine oxidase inhibitors (RIMAs) are safer but have failed to consistently demonstrate significantly superior effects over placebo for this disorder [14], [15]. The SSRIs represent an attractive medication choice for social phobia due to their effectiveness and the absence of problems associated with either the MAOIs or the benzodiazepines [5], [16]. A number of the SSRIs have demonstrated effectiveness in randomized controlled trials of social phobia [17]. These include paroxetine [18], [19], fluvoxamine [20], [21] and sertraline [22]. Few studies have investigated the durability of treatment effects in social phobia over the longer term for either the MAOIs or SSRIs. Some studies have found that taking these medications over a longer treatment period reduces social phobia symptoms and the risk of relapse [23–25]. However, once medication is discontinued, relapse rates are high [25–27].

In comparison, it has been demonstrated that treatment gains are maintained in the longer term after completing a cognitive behaviour therapy (CBT) treatment program for social phobia [28]. Cognitive behaviour therapy is the psychological treatment of choice for this disorder, demonstrated to be superior in comparison with credible placebo in the short term [12], [29] and long term [8]. Equivalent effect sizes are obtained for group- and individual-based CBT [30], although CBT is most cost-effective when delivered in a group format [31]. Treatment gains are generally maintained at 6 and 12 months [8], [29], with treatment effects evident up to 5 years post-treatment [28]. However, there is still room for improvement in terms of the proportion of treatment completers achieving high end-state functioning following CBT, particularly at the severe end of the social phobia continuum [8], [32].

Although the outcomes of CBT versus pharmacotherapy for social phobia generally reflect similar effectiveness and attrition rates in the short term [9], [31], there are insufficient pharmacotherapy studies with follow-up data to report on the maintenance of treatment gains in the longer term. In clinical practice, the concurrent application of medication and CBT is common; however, very few studies have investigated the effectiveness of a combined treatment approach for social phobia. As described by Heimberg [30], there are three possible outcomes from combining medication and CBT. Combined treatment may produce a better outcome than each treatment alone, by potentiating the gains achieved by CBT and also reducing relapse rates when medication is discontinued. Alternatively, there may be no difference between the combined approach versus either approach individually, if both CBT and pharmacotherapy are sufficiently powerful on their own. It is also possible that medication might detract from the effectiveness of CBT if participants attribute treatment gains from a combined approach to the medication and not to the cognitive and behavioural strategies. The limited research to date has not found a significant advantage for combination treatment over CBT or pharmacotherapy alone for social phobia [9], [31], [33]. However, the most effective medications have not necessarily been included [34], [35], while the full complement of CBT components has not always been used in the combined treatment condition [36]. The duration and structure of CBT and the mode of treatment delivery (individual vs. group) varies between studies and between different experimental conditions [36] and samples have not necessarily been representative of clinical populations [34]. Interestingly, results of a recent study have suggested that in the long term, exposure alone may be more effective than in combination with sertraline in the treatment of social phobia [37]. Further research is needed to investigate the use of a combination of CBT and effective medications in social phobia [30], [31].

This current project replicates the methodology of Oei et al. [38], [39] in examining the effect of concurrent antidepressant use in a large clinical sample of people undergoing CBT for social phobia in a routine setting. It is a naturalistic study investigating the impact of preexisting antidepressant medication on the outcome of a group-based, structured CBT program for social phobia.

Method

Participants

A total of 148 participants (78 female and 70 male; mean age 34.3 years; SD = 10.2) were included from a total of 153 consecutive adult outpatients undergoing a group-based cognitive behavioural treatment program for social phobia at the Anxiety Disorders Clinic, St. Vincent's Hospital, Sydney, over a 2 year period. Of the total of 153 outpatients, five were excluded from the study due to social phobia not being the primary diagnosis (n = 4), or to an absence of data at pretreatment (n = 1). Participants completed this study as part of their routine assessment at the Clinic. The assessment procedure involves an initial interview with an experienced staff psychiatrist, a second interview with a psychiatry registrar to confirm diagnosis and treatment recommendation, and a computerized version of the Composite International Diagnostic Interview (CIDI-Auto), which provides a diagnostic assessment according to both DSM-IV and ICD-10 (12 month version) [40]. A computerized version of the International Personality Disorders Examination Questionnaire [41], which is a screener for ICD-10 personality disorders, is also routinely administered. For the purposes of describing the clinical characteristics of the sample, the only additional disorders of interest were depression or dysthymia, and anxious (avoidant) personality disorder. On clinical interview, all 148 participants met criteria for a primary DSM-IV diagnosis of social phobia. Patients were not accepted into the treatment program if they were currently using benzodiazepines or if they met a primary diagnosis of major depression. Patients with current substance abuse or dependence, psychotic disorder, or active suicidal ideation, were also excluded. A battery of self-report questionnaires was administered at each assessment occasion as part of routine outcome evaluation for the Clinic. In the majority of cases, questionnaires were administered via computer. If computers were not available, participants completed pen and paper versions. Participants' responses on questionnaires administered on the first day of the treatment program served as the pretreatment measure and responses on the final day of the treatment program (7 weeks later) served as the post-treatment measure.

For the purposes of this study, it was necessary to determine whether participants had already been prescribed an antidepressant at the time of attending the Anxiety Disorders Clinic. Participants' antidepressant medication status was determined at their first and second assessment interviews, as a routine part of the clinical assessment. If participants were taking an antidepressant prescribed by their GP or psychiatrist, they were strongly advised to continue their medication while undergoing the social phobia CBT program at the Clinic. This was also emphasized on the first day of the treatment program by the treating clinician. Two additional measures were undertaken to confirm medication status. First, a subsample of participants who were enrolled in the treatment program at the time of the study (n = 52, 35%) were administered a brief questionnaire regarding medication use on the first and last days of the treatment program. For these patients, there was 100% concordance with their self-reported medication status and their medication status as documented in the file. Second, an attempt was made to retrospectively confirm the medication status of the remaining participants (65%; n = 96 of the total sample) who had attended the treatment program an average of 10 months (range 2–24 months) previously. Fifty-seven of these participants (59%) responded to contact by telephone or mail. For these participants, there was 100% concordance with medication status as documented in the patient file and retrospective self-reported medication status. These participants were also questioned about further treatment-seeking since completing the program.

Of the 148 participants in the study, 55 (37.2%) reported taking antidepressants at the time of treatment, while 93 (62.8%) reported not taking antidepressants. Fifteen study participants did not complete the treatment program, leaving a final sample of 133 treatment completers. Forty-nine participants (36.8%) reported taking antidepressants and they comprised the CBT ++ AD group and 84 participants (63.2%) comprised the CBT group.

Treatment program

The social phobia group treatment program involved 40 hours of cognitive behaviour therapy over a 7 week period, with three consecutive days initially, followed by six weekly sessions of 3 hours duration. Participants also attended a group follow-up appointment 1 month after the completion of the program. Groups consisted of 6–8 participants and were conducted by an experienced clinician (clinical psychologist or psychiatrist) trained in the use of CBT for the treatment of anxiety disorders. The treatment program was structured and manualized [42]. The effectiveness of the treatment program over the short and longer term was supported by clinical research [43–45]. The main elements of the treatment program included a combination of graded exposure to feared situations and cognitive therapy aimed at modifying anxious beliefs associated with social situations. In collaboration with the clinician, participants designed individualized exposure programs and completed a series of exposure tasks both within-session and as weekly homework assignments.

Questionnaire measures

Social Phobia Scale (SPS) and Social Interaction Anxiety Scale (SIAS)

The SPS and SIAS [46] are companion measures assessing social phobia symptom severity. The SPS primarily assesses anxiety about performing in front of others or being observed by other people, while the SIAS assesses anxiety associated with interpersonal interactions. Each scale has twenty items rated on a 4-point scale, from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or true of me), with scores for each scale ranging from 0 to 80. The SPS and SIAS demonstrate good sensitivity to treatment effects for social phobia [47].

The Fear of Negative Evaluation Scale (FNE)

The FNE [48] is a 30-item questionnaire developed to measure fear of negative evaluation, particularly in social situations. Items are rated as true or false, with the total score ranging from 0 to 30, and a higher score indicating greater fear of negative evaluation.

Eysenck Personality Questionnaire – Neuroticism Scale (EPQ-N)

The EPQ [49] is a 44-item questionnaire which provides a measure of neuroticism (23 items) and extraversion (21 items). Only the responses on the neuroticism scale were of interest in this study. The total score on the EPQ-N ranges from 0 to 23. As it is regarded as a trait measure, the EPQ-N was only administered on the one assessment occasion (pretreatment).

Depression Anxiety and Stress Scale (DASS-42)

The DASS-42 [50] is a 42-item questionnaire with three 14-item subscales measuring states of anxiety, depression and stress. Only responses on the depression subscale were of particular interest in this present study. Items on the DASS-42 are rated on a scale of 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), with the total score for the depression subscale ranging from 0 to 42.

Short Form-12 (SF-12)

The SF-12 [51] is a measure of disability. Two scales are obtained from the SF-12: the Mental Component Summary and the Physical Component Summary. The scales are scored such that the mean is 50 and the standard deviation is 10. Lower scores on this measure indicate poorer functioning or greater disablement. Responses on only the Mental Component Summary were of interest in this study, as they reflect disability due to psychological problems/symptoms.

Results

Sample characteristics

There were no significant differences at pretreatment between the CBT group and the CBT ++ AD group in terms of age (t_1,146 = − 1.62; p = 0.11) or neuroticism score (t_1,131 = −1.33; p = 0.19). Chi-square analyses indicated that there were no significant differences at pretreatment between the two groups in regard to gender distribution and (CIDI-Auto) rates of depression or dysthymia, and anxious/avoidant personality disorder (χ² = 0.00–0.17; p < 0.05 for all comparisons).

Treatment dropouts

Rates of dropouts did not differ significantly between the CBT group (9.7%; n = 9) and the CBT plus antidepressant (CBT ++ AD) group (10.9%; n = 6) (χ² = 0.06; p < 0.05). There were no significant differences at pretreatment between treatment completers (n = 133) and dropouts (n = 15) in terms of age (t_1,146 = 0.41; p = 0.68), neuroticism score (t_1,131 = − 0.47; p = 0.64), DASS-Depression score (t_1,145 = 0.13; p = 0.90), scores on the Social Phobia Scale (t_1,141 = 0.64; p = 0.52), the Fear of Negative Evaluation Scale (t_1,41 = 0.48; p = 0.63), or the SF-12 (t_1,146 = 0.09; p = 0.93). There was a trend for treatment completers to score more severely on the Social Interaction Anxiety Scale at pretreatment (t_1,141 = 1.91; p = 0.058).

Between group comparisons

Mean scores, standard deviations and effect sizes for each group on the questionnaire measures at pretreatment and post-treatment are presented in Table 1. Within-group effect sizes were calculated using the pretreatment standard deviation for each group [52]. A Bonferroni corrected alpha rate of 0.01 was applied to reduce the risk of experimentwise error. A series of repeated measures, ANOVAs, was conducted, using each of the questionnaire measures as the dependent variable.

Table 1.

Mean scores and within-group effect sizes (ES) for the cognitive behaviour therapy group (CBT) and the cognitive behaviour therapy plus antidepressant group (CBT ++ AD) on questionnaires at pre- and post-treatment^†

There was no significant main effect of group on any dependent variable: DASS-Depression (F_1,122 = 2.56, p = 0.11); SPS (F_1,117 = 1.16, p = 0.28); SIAS (F_1,117 = 1.34, p = 0.25; FNE (F_1,117 = 1.27, p = 0.26); SF-12 mental component summary (F_1,123 = 0.55, p = 0.46). There was also no significant interaction between the two groups on any dependent variable: DASS-Depression (F_1,122 = 0.84; p = 0.36); SPS (F_1,117 = 0.02; p = 0.88); SIAS (F_1,117 = 0.45, p = 0.51); FNE (F_1,117 = 0.51, p = 0.48); and SF-12 (F_1,123 = 0.03, p = 0.87).

There was a main effect of treatment across both groups for all dependent variables: DASS-Depression (F_1,122 = 63.91, p < 0.001); SPS (F_1,117 = 110.02, p < 0.001, SIAS (F_1,117 = 88.40, p < 0.001); FNE (F_1,117 = 51.96, p < 0.001) and SF-12 (F_1,123 = 55.18, p < 0.001). Medium to large effect sizes were obtained for all variables across treatment, within each group.

Further treatment seeking over the follow-up

Of the 96 participants (65.0% of the total sample) who had completed the treatment program on average 10 months previously, only 59.0% (n = 57) were able to be followed up and questioned about further treatment-seeking. Of these participants, 33.0% (n = 19) reported receiving further treatment for social phobia since completing the program. A greater proportion of respondents in the CBT group reported receiving further treatment for their social phobia (45.2%; n = 14), in comparison with the CBT ++ AD group (19.2%; n = 5) (χ² = 4.28; p = 0.039). Of the 14 respondents in the CBT group who reported receiving further treatment, eight reported seeking additional psychological treatment, five reported being prescribed medication and one respondent reported seeking both psychological treatment and medication. Of the five respondents in the CBT ++ AD group who reported receiving further treatment, four respondents reported seeking further psychological treatment, with one respondent reporting further psychological treatment and medication. No respondent in this group reported seeking additional pharmacotherapy for social phobia.

Discussion

This study aimed to examine the impact of preexisting antidepressant medication on the outcome of cognitive behavioural group therapy for social phobia. Of the total sample of participants who completed the CBT program, over a third (37%) reported using antidepressants and comprised the CBT plus antidepressant group (CBT ++ AD), while the remaining 63% comprised the CBT group. Moderate to large effect sizes were demonstrated for both groups overall from pre- to posttreatment on all symptom measures, reflecting the significant improvement for the total sample (on average) over the treatment period. No significant differences were demonstrated between the two groups in terms of performance pre- to post-treatment. Taking antidepressant medication while participating in a CBT program for social phobia did not enhance or detract from the significant improvement on mood, social anxiety and disability measures. This is consistent with previous research which has failed to find a significant advantage for combined pharmacotherapy and CBT, compared with CBT alone, or pharmacotherapy alone, in social phobia [9], [31], [33]. This is an important finding, as the current study avoided many of the methodological shortcomings which may have limited the clinical generalizability of previous research, by comparing CBT to combined treatment using effective medications in a clinically representative sample, and by ensuring the full complement of CBT components were included in the combination treatment condition. A similar finding of no difference between combined treatments versus CBT alone has also been found in naturalistic studies of preexisting antidepressants in combination with CBT for both panic disorder and depression [38], [39].

The failure to find a significant difference between the combination treatment (CBT ++ antidepressants) and CBT (alone) could be interpreted to indicate that taking antidepressants does not enhance treatment gains in social phobia. It is possible that, since antidepressants and CBT are both reasonably powerful treatments individually, a combination of the two did not contribute significantly to an improved outcome. However, it is also possible that the group who were taking antidepressants may have been prescribed the medication because they were more severe in terms of depressive and/or social phobia symptoms, prior to commencing the treatment program.

The significant improvement on all measures in the CBT group following treatment is consistent with previous research demonstrating the effectiveness of cognitive behaviour therapy alone in the treatment of social phobia [8], [12], [29]. Although both groups are still outside the normal range on social anxiety measures at the end of treatment [53], this is consistent with published outcome data reflecting participants' improvement status at this stage in the recovery process [46], [47]. Despite residual social anxiety symptoms, average disability scores (SF-12) for both groups were no longer in the clinical range by the end of treatment, indicating that the impact of social phobia on participants' daily lives had reduced significantly.

There were no significant differences between the CBT group and the CBT ++ AD group in terms of rates of treatment dropouts. Regarding further treatment-seeking since completing the program, a greater proportion of respondents in the CBT group reported seeking further treatment, in comparison with the CBT ++ AD group. However, conclusions regarding this follow-up data are limited by the possibility of response bias, as only 59.0% of participants who had completed treatment on average 10 months previously were successfully followed up. A further limitation is that it was not established whether participants in the CBT ++ AD group who were followed up had continued to take the antidepressant medication prescribed at the time of treatment.

The naturalistic design of this study has the advantage of reflecting the typical rate of pre-existing antidepressant use in a clinical sample of participants attending an anxiety disorders clinic for CBT of social phobia. Disadvantages of the naturalistic design include the nonrandom allocation of participants to groups and the absence of uniformity in medications and dosages. Interpretation of the results of this study may be limited by a lack of statistical power to detect a small effect size difference between the two groups [54]. The issue of the effectiveness of combination treatment for social phobia requires further investigation using controlled treatment trials. Traditionally, combining medications and CBT has involved the simultaneous application of the two treatments; however, this notion could be broadened to incorporate different sequences of the treatments [30]. From a clinical perspective, issues to explore in future controlled research include whether introducing an antidepressant prior to attempting a time-limited, CBTbased program has a significant impact on treatment outcome for people at the severe end of the social phobia spectrum. Future research also needs to address the question of whether treatment effects in social phobia are maintained over the longer term to an equivalent extent for CBT alone, pharmacotherapy alone, or a combined approach.

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Pre-Existing Antidepressants and the Outcome of Group Cognitive Behaviour Therapy for Social Phobia

Abstract

Keywords

Method

Participants

Treatment program

Questionnaire measures

Social Phobia Scale (SPS) and Social Interaction Anxiety Scale (SIAS)

The Fear of Negative Evaluation Scale (FNE)

Eysenck Personality Questionnaire – Neuroticism Scale (EPQ-N)

Depression Anxiety and Stress Scale (DASS-42)

Short Form-12 (SF-12)

Results

Sample characteristics

Treatment dropouts

Between group comparisons

Further treatment seeking over the follow-up

Discussion

References