Social phobia is becoming increasingly recognized as a prevalent disorder, frequently associated with significant impairment in multiple domains. Epidemiologic studies have estimated the prevalence of social phobia to be between 3% and 13%,1¿ In the recent National Comorbidity Survey, social phobia was the third most prevalent psychiatrie disorder, surpassed only by major depressive disorder and alcohol dependence.3
Concerns of individuals with social phobia typically center on fears of being embarrassed or humiliated while interacting with or being observed by others. Individuals with social phobia in the community report significant interference with their daily activities when compared with those without social phobia.1 They also tend to be less educated, less likely to be married, and of lower socioeconomic status.1'2 In addition, they report significantly more suicidal ideation, and there is a nearly sixfold increase in suicide attempts when social phobia is comorbid with another psychiatric disorder.2 Most individuals with social phobia presenting for treatment report at least moderate disruption in many areas, including school, work, family and romantic relationships, and friendships.4
With growing recognition of the prevalence and morbidity of social phobia, increasing research attention has focused on examining the efficacy of therapeutic interventions. Both pharmacologic and cognitive-behavioral treatments have demonstrated efficacy.
Several pharmacologic interventions have shown promise in the treatment of social phobia. In the International Consensus Group on Depression and Anxiety's "Consensus Statement on Social Anxiety Disorder," the selective serotonin reuptake inhibitors (SSRIs) were recommended as first-line agents in the treatment of social phobia because of their demonstrated efficacy and relative tolerability.5 Other medications, including monoamine oxidase inhibitors (MAOIs) and benzodiazepines, have also demonstrated efficacy. However, the necessity of restrictive diets and the danger of hypertensive crisis limit the use of MAOIs, whereas concerns about abuse and dependence curtail the use of benzodiazepines. Nonetheless, alternative agents may play an integral role in the treatment of patients who are nonresponsive or minimally responsive to initial trials of SSRIs or who are sensitive to the side effects typically associated with these compounds (Table 1).
SSRIs have a generally favorable side effect profile, with most side effects described as mild to moderate and rarely necessitating discontinuation of medication in large clinical trials.6,7 Additionally, given their efficacy in disorders that frequently co-occur with social phobia, such as depression and other anxiety disorders, SSRIs are attractive therapeutic options for clinicians.
Medications for the Treatment of Social Phobia
The strongest support for the use of SSRIs comes from controlled studies examining the efficacy of paroxetine. Two large multicenter, flexible-dose studies (one in Europe and South Africa6 and the other in the United States and Canada7) demonstrated significantly greater improvement in patients treated with paroxetine compared with patients treated with placebo. In both studies, treatment with paroxetine was initiated at 20 mg/d and titrated upwards in weekly 10-mg increments to a maximum dose of 50 mg/d; the mean maximum dosages in the European-South African and the North American studies were 34.7 and 36.6 mg/d, respectively.
With the use of intent-to-treat analyses that included all patients who received at least one post-baseline evaluation, 65.7%6 and 55%7 of the patients treated with paroxetine were designated acute responders (after 12 weeks of treatment for the European-South African study and 11 weeks for the North American study). Unless otherwise noted, all references to "responders" reflect the common classification of all patients receiving a rating of "much improved" or "very much improved" on the Clinical Global Impression Scale - Improvement rating.8 These percentages were significantly better than the 32.4% and 23.9% of patients receiving placebo who were classified as responders in these studies. Additionally, improvement in Liebowitz Social Anxiety Scale9 ratings was significantly greater among patients receiving paroxetine than among patients receiving placebo.
Additional support comes from a single-site, placebo-controlled study of 92 patients with social phobia conducted in Sweden.10 In the intent-totreat analysis, 70.5% of those taking paroxetine were classified as responders, whereas only 8.3% of those taking placebo were classified as responders.
Despite these high response rates, concerns about relapse after discontinuation of medication are common. Stein et aln examined discontinuation of paroxetine following successful open-label treatment of social phobia. Sixteen patients were randomly assigned to either continued treatment with paroxetine or paroxetine tapered to placebo on a double-blind basis. Thirteen percent (1 of 8) of those who continued to receive paroxetine had a relapse after 12 weeks, whereas 63% (5 of 8) of those switched to placebo had a relapse. Although these differences were not significant (likely because of the small sample size), they suggest that discontinuation after brief treatment may lead to increased relapse rates.
Two double-blind, placebo-controlled studies of fluvoxamine demonstrate its efficacy in the treatment of social phobia.12-13 In a multicenter study of 92 patients with social phobia in the United States,13 those treated with fluvoxamine (mean daily dose 202 mg) who completed at least one post-baseline assessment were more likely to be classified as responders (42.9%) than were those in the placebo group (22.7%). Statistically significant differences between groups on Liebowitz Social Anxiety Scale and self-report measures were apparent after 6 and 8 weeks of treatment, respectively.
Similar results were found in a single-site study in The Netherlands in which 30 patients were treated with fluvoxarnine (150 mg/d) or placebo.12 Forty-six percent (7 of 15) of the patients treated with fluvoxamine experienced at least a 50% reduction in Liebowitz Social Anxiety Scale score after 12 weeks of treatment, compared with 7% (1 of 15) of the patients treated with placebo.
Evidence for the efficacy of sertraline includes a small (12 patients), double-blind, placebo-controlled, crossover study.14 Those taking sertraline (mean dose 133.5 mg/d) demonstrated statistically significant gains on the Liebowitz Social Anxiety Scale, whereas those taking placebo did not. In addition, 50% of the patients treated with sertraline were at least moderately improved compared with 9% receiving placebo. Finally, the efficacy of fluoxetine and Citalopram has been demonstrated in open trials,15,16 but more controlled research on these compounds has yet to be published.
Prior to the advent of the SSRIs, MAOIs were considered the medication oí choice for social phobia. However, concerns about tolerability and safety have limited their widespread use. Four placebo-controlled studies provide consistent demonstration of the therapeutic benefits of phenelzine.17'20 Liebowitz et al.18 examined response to phenelzine, the beta-blocker atenolol, and placebo in an 8-week, double-blind study. Patients treated with phenelzine (mean dose 75.7 mg/d) who completed at least 4 weeks of treatment improved significantly more than did those given atenolol or placebo, achieving response rates of 64%, 30%, and 23%, respectively.
In a comparison of phenelzine (mean dose 55 mg/d), alprazolam, cognitive-behavioral group treatment, and placebo,17 the groups (including placebo) did not differ significantly from one another on most self-report measures or in response rates after 12 weeks of treatment. However, all of the patients (including those receiving placebo) received instructions from the physician to expose themselves to feared situations, which serves to confound comparative efficacy analyses. In a comparison limited to the medication and placebo conditions, phenelzine and alprazolam were found to differ significantly from placebo on a physician-rated measure of disability. After a 2-month medication-free period, the phenelzine group continued to show significantly less disability than did the placebo group; however, the alprazolam group no longer differed from the placebo group.
A placebo-controlled comparison of phenelzine and moclobemide (a reversible inhibitor of MAO-A) further supports the efficacy of phenelzine.19 Patients treated with phenelzine (mean dose 67.5 mg/d) and patients treated with. moclobemide were found to show greater improvement on both clinician-adrninistered and self-report measures than were patients treated with placebo after 8 weeks of treatment; however, patients treated with phenelzine responded more quickly, demonstrating superior response (as compared with moclobemide and placebo) after 4 weeks of treatment.
Finally, the most recent investigation compared phenelzine with cognitive-behavioral group treatment, educational-supportive group therapy, and placebo.20 After 12 weeks of treatment, phenelzine and cognitive-behavioral group therapy did not differ from one another in terms of response rates in the intent-to-treat analysis (65% and 58%, respectively), and both were significantly more efficacious than were educational-supportive group therapy and placebo (27% and 33%, respectively). However, phenelzine performed better than did cognitive-behavioral group therapy on some measures. Patients who received phenelzine also showed greater improvement at 6 weeks than did patients who received cognitive-behavioral group therapy, indicating that the response to phenelzine was associated with more rapid alleviation of symptoms. In a follow-up analysis,21 the groups did not differ from one another after 6 months of maintenance treatment; however, 6 months after discontinuing treatment, the phenelzine group showed a trend toward greateT relapse than did the cognitive-behavioral group therapy group.
Concerns about the restrictive diet and the potential for hypertensive crisis associated with MAOIs led to investigations of the efficacy of reversible inhibitors of MAO-A. These drugs are less susceptible to tyramine-induced side effects, and, therefore, do not require patients to maintain restrictive diets. Early studies provided strong support for the efficacy of brofaromine,22,23 but the results for moclobemide have been less positive.24 However, neither of these compounds is currently marketed in the United States.
High-potency benzodiazepines have demonstrated efficacy for the treatment of social phobia, although the evidence is stronger in support of clonazepam than in support of alprazolam. In the study by Gerlernter et al.17 of 65 patients with social phobia described previously, those treated with alprazolam (mean dose 4.2 mg/d) showed significant improvement on all self-report measures after 12 weeks of treatment. Additionally, these patients were rated by their physician as being significantly less impaired than patients taking placebo; however, the alprazolam group was rated as more impaired than the phenelzine group. Two months after drug discontinuation, the alprazolam group was mdistinguishable from the placebo group on all measures, demonstrating a high rate of relapse. As noted previously, all patients in this study received exposure instructions, making the interpretation of these results difficult.
A double-blind, placebo-controlled study provided support for the efficacy of clonazepam in the treatment of social phobia.25 Seventy-five patients were randomized to treatment with clonazepam (mean maximum dose 2.4 mg) or placebo for 10 weeks. Response rates were 78.3% and 20.0% for clonazepam and placebo, respectively, in an intent-to-treat analysis. Response rates differed significantly on some measures the first week after initiating treatment; differences on other rating scales were apparent by week 2 or 6, depending on the measure. In a follow-up of those who completed treatment 2 years after the discontinuation of medication,26 the clonazepam group continued to exhibit significantly less symptomatology than did the placebo group. However, these results may have been confounded by significantly more of the patients in the clonazepam group seeking additional treatment.
One of the primary concerns in long-term therapy with benzodiazepines is the development of physical dependence and withdrawal symptoms following discontinuation. Connor et al.27 examined this phenomenon in a group of 36 patients who had completed 6 months of successful treatment with clonazepam and then received either continued clonazepam or placebo-replacement slow taper in a double-blind fashion for an additional 5 months. Their results suggest low and similar rates of withdrawal symptoms in both groups (clonazepam 12.5%; placebo-replacement slow taper 27.7%). Relapse rates were 0% in the clonazepam group and 21.1% in the placebo-replacement slow taper group, suggesting that continued treatment may be necessary in some cases.
Beta-blockers reduce autonomic arousal symptoms such as heart palpitations, shaking, and sweating. Therefore, it has been suggested that they might be effective for performance anxiety and social phobia. However, in the double-blind, placebo-controlled comparison of phenelzine and atenolol (mean dose 97.6 mg/d) performed by Liebowitz et al.,18 the 8-week response rate for atenolol (30%) did not differ from that tor placebo (23%) and was significantly less than that for phenelzine (64%). These results suggest that atenolol is not effective for the treatment of social phobia; however, controlled trials have yet to be conducted in which only the treatment of discrete performance fears is targeted.
Several other medications have been evaluated as treatments for social phobia. In an initial series of patients treated with venlafaxine, approximately 50% responded after 8 weeks of treatment (dose range 75 to 300 mg/d); however, the authors also reported a high prevalence of side effects.28 The efficacy of the novel antidepressant nefazodone was examined in a series of 5 patients with social phobia.29 With the use of an intent-totreat analysis, patients treated with nefazodone (mean dose 370 mg/d) showed significant improvement from baseline on both clinicianadministered and self-report measures. Controlled trials of venlafaxine and nefazodone are needed to substantiate their usefulness in the treatment of social phobia. Imipramine (mean dose 222 mg/d) was found to be only minimally efficacious for 15 patients treated openly for 8 weeks; in addition, 6 patients dropped out of the trial due to adverse events.30 The anxiolytic buspirone was ^distinguishable from placebo in a double-blind trial.31 Thirty patients received buspirone (30 mg/d) or placebo for 12 weeks; the two groups did not differ from one another on a number of dMdan-admLnistered and self-report measures.
Gabapentin, a novel anticonvulsant agent, has shown promise in an initial double-blind comparison with placebo.32 Patients treated with gabapentin (maximum dose range 900 to 3,600 mg/d) demonstrated significantly greater improvement in Liebowitz Social Anxiety Scale scores than did patients treated with placebo. There was also a trend toward greater response in the intent-to-treat gabapentin sample (32%, using a criterion of at least 50% improvement on the Liebowitz Social Anxiety Scale) than in the placebo sample (14%). Although the response rate for gabapentin in this study is apparently lower than that in studies of other medications, gabapentin may still be a potentially useful agent in the treatment of patients who are unresponsive to other agents.
COGNITIVE-BEHAVIORAL THERAPY (CBT)
The International Consensus Group on Depression and Anxiety5 additionally addressed the implementation of psychosocial treatments for social phobia, concluding that the only wellsupported psychosocial intervention for social phobia was CBT. Because of the dearth of research on other types of psychosocial treatment for social phobia, we limit the focus of this review to cognitive-behavioral methods.
Several combinations of cognitive and behavioral techniques have been studied, and there is a debate in the literature about the comparative efficacy of behavioral versus combined cognitive and behavioral interventions. Three meta-analyses of the literature regarding the outcome of cognitive-behavioral treatment have been published.33-35 In the meta-analysis by Feske and Chambless,35 cognitive-behavioral (n = 12) and exclusively exposure-based (n = 9) treatments did not differ from one another. In an examination of the literature on treatment outcome performed by Gould et al.,33 the results suggest that among psychosocial treatments, those with an exposure component (including both combined cognitive-behavioral treatments and pure exposure treatments) produced significantly larger gains than did either cognitive restructuring alone or social skills training alone.
Finally, Taylor34 included 42 treatment trials in a meta-analysis of cogninVe-behavioral treatments for social phobia. Effect sizes were computed for 6 conditions: waiting-list control, placebo, cognitive restructuring alone, exposure alone, combined cognitive restructuring and exposure, and social skills training. All active treatments were significantly better than waiting-list control conditions; however, only combined cognitive restmcturing and exposure achieved significantly better results than placebo controls. These data suggest that there may be an incremental benefit for adding cognitive techniques to exposure therapy for social phobia.
Components of Heimberg's Cognitive-Behavioral Group Therapy
Many different combinations of cognitive and behavioral methods have been applied in the literature regarding the treatment of sodai phobia. For the sake of clarity, we focus on one particularly well-elucidated and thoroughly examined treatment package, Heimberg's cognitive-behavioral group therapy.36 Although there have been minor modifications in the treatment protocol during the time period in which it has been studied, the following represents a description of the treatment as currently implemented (Table 2).
Cognitive-behavioral group therapy is typically conducted by two therapists in 12 weekly, 2Vihour sessions with groups of 5 to 7 patients. In the first two sessions, the cognitive-behavioral model of sodai phobia is presented, with patients being taught to identify negative cognitions (or automatic thoughts), examine the relationship between negative cognitions and anxiety, challenge logical errors in these thoughts, and come up with rational alternatives. Beginning in the third session, patients participate in exposure exerdses to increasingly difficult feared situations during the group session while applying the cognitive skills described above. Additionally, patients are given homework assignments in which they are instructed to expose themselves to feared situations in real life while applying learned cognitive techniques.37
The first controlled study of cognitive-behavioral group therapy compared this treatment with educational-supportive group therapy, which consists of education about sodai phobia and mutual sharing and support, that served as an attention control.38 Ratings of treatment credibility were essentially equivalent in the two treatment conditions. Although both groups demonstrated significant improvement from pretreatment levels, patients treated with cognitivebehavioral group therapy were rated by clinical assessors as significantly less impaired than patients treated with educational-supportive group therapy immediately posttreatment and at the 6-month follow-up. The same pattern was noted for anxiety reported during a behavioral test. A subset of this group was observed and assessed approximately 5 years posttreatment.39 The group treated with cognitive-behavioral group therapy remained significantly more improved than the group treated with educational-supportive group therapy on several dinidanrated, self-report, and behavioral measures.
Three studies dted earlier also examined cognitive-behavioral group therapy.17,20'21 As mentioned earlier, an investigation of cognitivebehavioral group therapy, phenelzine, alprazolam, and pill placebo by Gerlernter et al.17 did not significantly differentiate any of the treatments from placebo on self-report questionnaires or in terms of response rates. However, these results are difficult to interpret because all of the patients, including those in the placebo group, received instructions for self-exposure, an integral component of cognitive-behavioral group therapy.
An examination of cognitive-behavioral group therapy, phenelzine, educational-supportive group therapy, and pill placebo by Heimberg et al.20 demonstrated the superiority of cognitivebehavioral group therapy to educational-supportive group therapy and pill placebo, after 12 weeks of treatment; additionally, cognitivebehavioral group therapy resulted in response rates similar to those produced by phenelzine. Although the group treated with phenelzine showed earlier improvement (indicated by more responders after 6 weeks), cognitive-behavioral group therapy was associated with a better longterm outcome.21 Relapse and dropout rates did not differ among the groups while treatment was maintained for 6 months; however, after an additional 6 months of treatment-free follow-up, there was a trend toward greater relapse in the phenelzine group. The difference in relapse rates was greatest among patients with the generalized type of sodai phobia.
ALTERNATIVES FOR TREATMENT-REFRACTORY SOCIAL PHORIA
Despite increased awareness and study of sodai phobia, little research has addressed the treatment of patients who are initially nonresponsive to acute treatment. The research dted above provides clear evidence that although many treatments are efficacious for social phobia, none has a 100% response rate; therefore, it is imperative that clinicians be aware of alternative treatment strategies.
A meta-analysis by Gould et al.33 demonstrated that cognitive-behavioral and pharmacologic interventions are equally effective in the treatment of sodai phobia; however, cost analysis suggested that CBT is the more cost-effective intervention. Therefore, referral for CBT may be indicated for patients with social phobia who are either partially responsive or nonresponsive to initial medication trials. Although studies have dearly demonstrated the efficacy of CBT alone, published research has yet to address the usefulness of combining CBT and medication treatment. However, given the substantial support for both modalities, the use of CBT as an adjunctive strategy should be considered.
Smoller and Pollack40 outline a strategy for managing pharmacotherapy-resistant anxiety. First, accurate differential diagnosis is essential, as well as identification and treatment of comorbidity. This may suggest either the selection of a medication with multiple indications (eg, the SSRIs for a patient with both depressive and anxiety disorders) or the combination of several agents (eg, the addition of mood stabilizers for comorbid bipolar disorders). Second, addressing issues of medication intolerance or noncompliance is cruda! to the achievement of adequate dosing. The authors recommend the use of adjunctive medications to treat side effects and a policy of low starting doses and gradual titration. Third, it is important to ensure that optimal medication trials are achieved, with attention to both adequate dosing and duration of trial. If these strategies are ineffective, a combination therapy may be indicated (eg, antidepressants and benzodiazepines). Finally, switching to another class of medication may be suggested for continuing nonresponse, including consideration of less wellstudied alternatives.
Recent research has demonstrated the efficacy of several strategies for the treatment of sodai phobia. Several classes of medications have been proven useful, inducting SSRIs, MAOIs, and benzodiazepines. In addition, research has begun to focus on the efficacy of several novel agents, with nefazodone, venlafaxine, and gabapentin showing promise in preliminary investigations.
Cognitive-behavioral therapies have also been well studied and demonstrated efficadous in the treatment of individuals with sodai phobia. Clinidans should be aware of alternative strategies for the treatment of sodai phobia because no treatment has yet been shown effective for all individuals. Therefore, treatment of individuals with sodai phobia should indude consideration of both medication and psychotherapy treatments alone as well as in combination with each other. Medication treatment of initially nonresponsive patients should pay careful attention to comorbid diagnoses and signs of medication intolerance or noncompliance and should begin with low starting doses and proceed with gradual titration to ensure adequate dosing and duration of treatment.
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Medications for the Treatment of Social Phobia
Components of Heimberg's Cognitive-Behavioral Group Therapy