Cognitive-Behavioral and Pharmacological Treatments of Social Phobia A Controlled
Study
Cheryl Shea Gelernter, PhD;
Thomas W. Uhde, MD; Peter Cimbolic, PhD; Diane B. Bernard J. Vittone, MD; Manuel E. Tancer, MD; John J. Bartko, PhD
patients with social phobia were treated in a a cognitive-behavioral group treatpharmacotherapy with alprazolam, phenelzine sulfate, or pill-placebo plus instructions for self-directed exposure to phobic stimuli. Statistically significant repeated-measures effects were shown on all measures, indicating that the treatments studied were associated with substantial improvements in patients with severe and chronic social phobia. Patients who were treated with phenelzine were rated by clinicians as more improved on a measure of work and social disability than patients who were treated with alprazolam or placebo (patients in the cognitive-behavior therapy group were not rated on this measure). Subjects showed positive cognitive changes from \s=b\ Sixty-five
study
that compared ment program with
before to after treatment, and there were no differences between treatment groups on the cognitive measure. We discuss the implications of these findings within the context of demographic and clinical predictors of response.
(Arch Gen Psychiatry. 1991;48:938-945)
social phobia classified than 20 years ago,u Although i syndrome 1980 that the American was
more
as a
discrete
it was not until Association formally
Psychiatric recognized social phobia as a discrete diagnostic entity.3 During the last decade, reviewers of the social phobia lit¬ erature have noted that this syndrome is among the least studied of the major anxiety disorders and have called for further research to address gaps in our knowledge conAccepted
for publication February 14, 1991. From the Section on Anxiety and Affective Disorders, Biological Psychiatry Branch (Drs Gelernter, Uhde, Vittone, and Tancer) and Division of Biometry and Applied Sciences (Dr Bartko), National Institute of Mental Health, Bethesda, Md, and the Counseling Center (Dr Cimbolic) and Department of Psychology (Dr Arnkoff), The Catholic University of America, Washington, DC. Dr Gelernter is now a research associate, Genetic Epidemiology Research Unit, Department of Psychiatry, Yale University School of Medicine, New Haven, Conn. Reprint requests to Section on Anxiety and Affective Disorders, Biological Psychiatry Branch, National Institute of Mental Health, 9000 Rockville Pike, Bldg 10, Room 3S-239, Bethesda, MD 20892 (Dr
Uhde).
Arnkoff, PhD;
cerning definition, prevalence, etiology, pathophysiol¬
ogy, assessment, and treatment.4~6 In their review of the social phobia literature, Liebowitz et al6 observed that this disorder has not been viewed by psychopharmacologists as a distinct syndrome worthy of independent study. Consequently, there are few controlled evaluations of treatments of social phobia. The drug that has been most studied for the treatment of social phobia is the monoamine oxidase inhibitor phenelzine sulfate; four controlled drug trials have been conducted that evaluated its effectiveness710 in treating patients with mixed or unspecified phobic conditions. The results of these early drug studies hinted at possible phenelzine efficacy for social anxiety, but limitations in the design of these studies made it difficult to reach de¬ finitive conclusions regarding the therapeutic benefits of monoamine oxidase inhibitor medications in the treat¬ ment of social phobia. Specifically, these older studies treated mixed samples of phobic patients, including patients with social phobia and agoraphobia, and the re¬ sults were not reported by diagnosis, making it impossi¬ ble to determine whether the patients with social phobia, as a separate group, improved at all. These investigations suggested a need for future studies with well-defined subject samples, adequate medication dosages and treat¬ ment duration, more comprehensive assessments, and well-controlled, double-blind designs. Two later trials of phenelzine in samples of patients with pure social phobia yielded additional data that sup¬ ported the efficacy of phenelzine for treatment of these patients. The first, an open pilot study, found that all pa¬ tients who were treated with phenelzine achieved mod¬ erate to marked improvement.11 The second study has been the only well-controlled investigation of phenelzine in a sample of patients with pure social phobia reported to date. In this latter study, Liebowitz and colleagues12 published an interim report of a double-blind, placebocontrolled comparison of phenelzine and atenolol, a ß-adrenergic blocker, in a sample of patients who met DSM-III criteria for social phobia. Preliminary data from this ongoing study have suggested that phenelzine, but not atenolol, may be an effective treatment of social pho¬ bia. However, these findings should be interpreted con-
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servatively, given the interim nature of the report and the presentation of only selected results from newly devel¬ oped outcome measures. Data regarding benzodiazepine treatments of social phobia are minimal. Although case reports13 and open clinical trials14 have suggested that alprazolam, a triazolobenzodiazepine useful in the treatment of panic disor¬ der,15-16 reduces social anxiety, no controlled study inves¬ tigating the effectiveness of alprazolam has been conducted for social phobia. Considered together, these data suggest possible phenelzine and alprazolam efficacy with social phobia. However, given the disparate patient population in the older studies and the preliminary nature and/or relatively small sample size of more recent trials, the value of these agents (ie, phenelzine and alprazolam) as treatments of pure social phobia remains to be established. Relatively few studies of cognitive-behavioral therapies in clinical populations of patients with social phobia have been conducted. The research in this area has focused on the efficacy of cognitive restructuring and exposure tech¬ niques, applied in isolation or as a part of a multicomponent treatment package. Results of these clinical studies have suggested that cognitive restructuring and exposure interventions are effective in the treatment of social anxiety.1725 However, no investigation has been con¬ ducted to establish the relative efficacy of cognitivebehavioral strategies and pharmacological approaches to the treatment of social phobia. The present investigation addressed this question by comparing the effects of a cognitive-behavioral group treatment with pharmacother¬ apy (phenelzine, alprazolam, and pill-placebo) plus in¬ structions for self-directed exposure to phobic stimuli. To our knowledge, this is the first methodologically rigorous investigation that compares pharmacotherapies for social phobia and the first controlled study that compares two pharmacotherapies with psychotherapy for this disorder. PATIENTS AND METHODS
majority of the patients who participated in this investi¬ gation were selected from a pool of respondents to a newspaper article in the "Health Section" of the Washington Post that described social phobia and a research program for its treatment The
at the National Institute of Mental Health, Bethesda, Md. Oth¬ ers came from a variety of referral sources, including other units at the National Institute of Mental Health and private practitio¬ ners. To be considered for participation, subjects had to be aged 18 to 60 years, free of medications, or able to discontinue any medications other than oral contraceptives, and willing to accept random assignment to treatment in a double-blind procedure. Prospective patients were sent a screening packet that contained of the program and two screening measures a brief
description for social phobia. Treatment applicants who reported subjec¬ tively distressing levels of social phobic anxiety and avoidance
either of the screening measures, ie, the Social Phobia Subscale of the Fear Questionnaire26 and the Social Avoidance and Distress Scale,27 were prescreened via telephone by one of us (C.S.G.). Eligible candidates for the treatment program were in¬ vited to the National Institute of Mental Health for a structured diagnostic interview. In the next phase of the screening process, the patients were evaluated by one of two clinical psychology doctoral candidates with the use of the Anxiety Disorders Interview ScheduleRevised28 and a modified form of the Schedule for Affective Dis¬ orders and Schizophrenia-Lifetime version.29 Criteria for inclu¬ sion were a primary diagnosis of social phobia by DSM-111 criteria and good physical health. Criteria for exclusion were (1) DSMon
diagnosis of major depression, melancholic subtype; (2) pregnancy or the intention to become pregnant during the 6 months of the study; (3) a history of psychosis; (4) an active sub¬ stance abuse problem; (5) presence of a medical condition that would contraindícate treatment with alprazolam or phenelzine; and (6) an inability to comply with rigorous protocol require¬ ments, including drug and dietary restrictions. Patients were not permitted to be in concurrent psychotherapy while they were participating in this protocol. Sixty-five patients were admitted to the active phase of the study, and 59 completed the treatment program and the follow-up assessment. Forty-eight patients (74%) had chief complaints of anxiety and avoidance of specific social situations. Seventeen patients (26%) complained of more generalized and pervasive social fears. Patients were classified as having specific social phobia if their main fear (the phobic situation for which they sought treatment) involved one or two of the following ac¬ tivities: public speaking, eating in public, writing while they were being observed, or using a public rest room. Those patients who reported fears of interacting in most social situations were designated as having generalized social phobia. This subtyping is consistent with DSM-III-R criteria. Differences among the treatment groups in distributions of these fears were not signif¬ Ill
icant.
and 41 women (63%), (SD, 9.6 years; age range, 18 to 60 years). Fifty-nine patients (91%) were white, and six (9%) were black or other minority. There were 32 married patients (49%), 29 single patients (45%), and four divorced or widowed patients (6%). Forty-two patients (64%) had at least a college education, with 16 patients (24%) having also completed graduate or pro¬ fessional training. Fourteen patients (22%) had completed some college, and seven patients (11%) had completed no higher ed¬ ucation after high school. Two patients (3%) had not completed secondary school. Forty-eight patients (74%) were employed full-time, and five patients (8%) worked part-time. Twelve patients (18%) were not employed. There were no statistically The with a
sample comprised 24 men (37%)
mean
age of 36.5 years
significant differences among treatment groups on any of these demographic variables by 2 test results. Although 27 patients (42%) had a history of major depression, only nine patients (14%) had affective disturbances (ie, dysthy¬ mic disorder) at the time of this study, and no patients currently met criteria for major depression. Several patients, however, met criteria for an additional DSM-III anxiety disorder, including generalized anxiety disorder (n 19 [29% ]), panic disorder (n 3 [5%]), and panic disorder with agoraphobia (n 1 [2%]). Thirtyeight patients (58%) had received prior treatment of their psychiatric conditions. There were no significant differences =
=
=
among treatment groups in terms of these characteristics, except for a significantly greater number of patients who had experi¬ enced a spontaneous panic attack in their lifetime in the phenelzine-treated group and significantly fewer patients who had previously sought treatment in the cognitive-behavioral therapy group.
Treatments
Subjects were randomly assigned to one of four treatment conditions: (1) cognitive-behavioral therapy, (2) pharmacother¬ apy with phenelzine and instructions for self-exposure to pho¬ bic stimuli, (3) pharmacotherapy with alprazolam and instruc¬ tions for exposure, or (4) pill-placebo and instructions for exposure. Treatment assignments were made following com¬ pletion of the pretest assessment. Fifteen subjects were assigned to each of the drug and placebo conditions, and 20 were assigned to the cognitive-behavioral therapy group. The difference in treatment group sizes resulted from a stratified randomization schedule (ie, one that assigned more patients to cognitivebehavioral therapy early in the subject selection process) that was designed to expedite the initiation of two 10-patient cognitive-behavioral therapy groups. Each of the treatments was 12 weeks in duration, and all patients were seen once weekly.
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Subjects in the active medication and placebo conditions were seen individually, while subjects in the cognitive-behavioral therapy condition were treated in a group format. At the first and fourth treatment sessions, all patients made ratings of treatment credibility and outcome expectancy using the Reactions to Treatment Questionnaire,30 a measure that comprised a series of 10-point scales with higher numbers indi¬ cating greater credibility or more positive outcome expectancies. Analyses of variance (ANOVAs) of items from the Reactions to
Treatment Questionnaire revealed that the four treatment groups did not show important statistical differences in their as¬ sessments of treatment credibility and outcome expectancy. It appeared, therefore, that the drug and cognitive-behavioral treatments were presented in a credible fashion and that patients in both the drug and cognitive-behavioral conditions held high expectancies for improvement. Thus, any resultant differences among groups on outcome measures were not likely to be due to credibility or expectancy effects.
Cognitive-Behavioral Therapy.—The cognitive-behavioral therapy condition was conducted in a group format by a team that comprised two clinical psychologists with postdoctoral training in cognitive therapy and experience in treating anxiety disorders. Two groups of 10 patients each met weekly for 2-hour sessions that were run according to a detailed social phobia treatment manual.30 Major treatment components were cognitive-restructuring techniques, in-session-simulated social exposures, and personalized homework assignments that re¬ quired both the use of cognitive-restructuring techniques and real-life exposure to previously avoided social situations. Ther¬ apists were oriented to the treatment protocol by an experienced cognitive therapist (D.B.A.), who remained available for con¬ sultation throughout the treatment program. All group sessions were audiotaped so that a manipulation check could later be performed. Two of us (C.S.G. and D.B.A.) monitored a sample
of these tapes to assess adherence to the treatment manual. Drug Treatments.—Medications were prescribed on an indi¬ vidual basis in a double-blind procedure by one of three psychi¬ atrists (M.E.T., B.J.V., and T.W.U.) who met weekly with each subject for 15- to 30-minute sessions. During the weekly sessions, physicians made ratings of patients' symptoms and impairment, adjusted medication doses, and firmly encouraged patients to push themselves into phobic situations. The physician's adher¬ ence to the treatment protocol was monitored by one of us (C.S.G.) who periodically observed or audiotaped patient visits to check that patients received nonspecific, supportive contacts with a focus on encouragement to engage in exposure. Subjects took medication four times daily on a fixed dosage schedule. Dos¬ ages began at 0.7 mg/d of alprazolam and 10 mg/d of phenelzine sulfate and were increased within 4 weeks to a maximum of 6.3 mg/d of alprazolam or 90 mg/d of phenelzine sulfate. Placebos and active medications were prepared by the pharmacy at the Na¬ tional Institutes of Health, Bethesda, Md, in identical capsules. The pharmacy staff established and maintained the key to the medication blind. Dosages were increased until all social phobic symptoms had disappeared, until side effects precluded further increases, or until the maximum dosage was reached. The mean dose of alprazolam prescribed was 4.2 mg/d (SD, 1.3 mg/d; range, 2.1 to 6.3 mg/d), and the mean dose of phenelzine sulfate pre¬ scribed was 55 mg/d (SD, 16 mg/d; range, 30 to 90 mg/d). At the end of the 12th week, capsules were tapered and discontinued according to a planned 4-week dosage-dependent schedule, al¬ though the blinded physicians were allowed to adjust the rate of taper according to their clinical discretion (range, 2 to 5 weeks). Response to the taper schedule was variable; only one patient ex¬ perienced withdrawal symptoms to an extent that warranted dis¬ charge on medication. No other patients reported symptoms of withdrawal at follow-up.
Assessment of Outcome
Scales.—Subjects were assessed at pretest (baseline), weekly during the treatment phase, at posttest (during the 12th week of
treatment before discontinuation of treatment), and at
follow-up
(2 months following discontinuation of treatment). This report will focus on pretest, posttest, and follow-up data from selfreport and physician-rated measures of social phobic and related
symptoms and of overall functioning. The
self-report measures were the Social Avoidance and Dis¬
Scale,27 Fear of Negative Evaluation Scale,27 Fear Question¬ naire,26 21-item Beck Depression Inventory,31 the State and Trait tress
forms of the Spielberger State-Trait Anxiety Inventory,32 the So¬ cial Interaction Self-Statement Test,33 and the Work and Social Disability Scale.34 The Social Avoidance and Distress Scale
0 to 28) and Fear of Negative Evaluation Scale (range, 0 30) were developed to measure the experience of anxiety and
(range, to
avoidance of social situations and the fear of being evaluated negatively by others. The Fear Questionnaire (range of the So¬ cial Phobia Subscale, 0 to 40) was designed to measure change in severity of phobic avoidance and distress. The 21-item Beck Depression Inventory (range, 0 to 63) measures manifestations of depression. The State and Trait forms of the Spielberger State-Trait Anxiety Inventory, both with a range of 20 to 80, measure state and trait anxiety. The Social Interaction SelfStatement Test assesses how frequently subjects make certain facultative and inhibiting self-statements during social interac¬ tions. It yields separate scores (range, 15 to 75) for positive and negative self-statements. The Social Interaction Self-Statement Test was administered at pretest and posttest immediately after a behavioral assessment that involved exposure to the patient's target phobic situation (eg, giving a speech, informal conversa¬ tion with a stranger, writing while observed). With the exception of the Social Interaction Self-Statement Test, patients completed this self-report battery at pretest, posttest, and follow-up. The physician-rated measure was the Work and Social Disability Scale,34 a five-point measure of symptoms and related impair¬ ment in work and social functioning (1 no disability, 2 mild, 3 moderate, 4 marked, and 5 severe). It was rated by the treating physicians at pretest, posttest, and follow-up during routine pharmacotherapy sessions. Analyses.—Three statistical methods were utilized to assess treatment effects as follows: (1) Outcome was assessed by anal¬ yses of covariance (ANCOVAs), with pretest scores serving as the covariate, to examine differential effects among the four treatment conditions.35 (2) To investigate treatment response across time within groups, repeated-measures ANOVAs were performed on the physician and patient-rated scales. (3) Finally, the patients were categorized as "responders" vs "nonre¬ sponders" after treatment according to whether subjects were below or above the mean (ie, 8.8) for the general population on the Social Phobia Subscale of the Fear Questionnaire.36-37 The Fear Questionnaire was chosen retrospectively to dichotomize the patients into responders and nonresponders because this measure has been found to be a valid and reliable measure of social phobic symptoms and accurately reflects change in re¬ sponse to treatment.26 Conservative Huynhfeldt probabilities were used for all ANOVAs, and post hoc analyses employed Bonferroni's t test. Bonferroni's f test is used for within-experiment tests. Post hoc comparisons are at the protected type 1 error of 5%. All proba¬ bilities less than .05 are considered to be significant, although selected probabilities less than .10 are presented in the written text or tables. =
=
=
=
=
RESULTS Of the 65 patients admitted, six (9.2%) failed to complete the treatment program. Three subjects (15%) in the cognitivebehavioral therapy group and three (6.7%) in a drug condition (two in the phenelzine-treated group and one in the alprazolamtreated group) terminated early. Of the patients in the cognitivebehavioral therapy group who dropped out, two terminated within the first 2 weeks of treatment because they did not per¬ ceive the treatment as appropriate for their problems, and one withdrew because his father was terminally ill. The patient in the
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Scale Social Avoidance and Distress
Total Fear QuestionnaireSocial Phobia
Pretest,
Posttest,
No.
Mean (SD)
Mean (SD)
Mean (SD)
AL
12 13
PP
15
18.0 (7.9)
17
18.2(9.3)
57
17.9(8.1),
10.2
15.7(5.5) 8.3 (6.2) 13.3 (8.8) 11.8(8.9) 12.2(7.9)b
(2,106) 49.2 (3,53)=1.63 (6,106)=1.0
CBT
10.7(7.9) 6.5 (6.3) 11.0 (7.4) 12.1 (8.7)
Study
Cheryl Shea Gelernter, PhD;
Thomas W. Uhde, MD; Peter Cimbolic, PhD; Diane B. Bernard J. Vittone, MD; Manuel E. Tancer, MD; John J. Bartko, PhD
patients with social phobia were treated in a a cognitive-behavioral group treatpharmacotherapy with alprazolam, phenelzine sulfate, or pill-placebo plus instructions for self-directed exposure to phobic stimuli. Statistically significant repeated-measures effects were shown on all measures, indicating that the treatments studied were associated with substantial improvements in patients with severe and chronic social phobia. Patients who were treated with phenelzine were rated by clinicians as more improved on a measure of work and social disability than patients who were treated with alprazolam or placebo (patients in the cognitive-behavior therapy group were not rated on this measure). Subjects showed positive cognitive changes from \s=b\ Sixty-five
study
that compared ment program with
before to after treatment, and there were no differences between treatment groups on the cognitive measure. We discuss the implications of these findings within the context of demographic and clinical predictors of response.
(Arch Gen Psychiatry. 1991;48:938-945)
social phobia classified than 20 years ago,u Although i syndrome 1980 that the American was
more
as a
discrete
it was not until Association formally
Psychiatric recognized social phobia as a discrete diagnostic entity.3 During the last decade, reviewers of the social phobia lit¬ erature have noted that this syndrome is among the least studied of the major anxiety disorders and have called for further research to address gaps in our knowledge conAccepted
for publication February 14, 1991. From the Section on Anxiety and Affective Disorders, Biological Psychiatry Branch (Drs Gelernter, Uhde, Vittone, and Tancer) and Division of Biometry and Applied Sciences (Dr Bartko), National Institute of Mental Health, Bethesda, Md, and the Counseling Center (Dr Cimbolic) and Department of Psychology (Dr Arnkoff), The Catholic University of America, Washington, DC. Dr Gelernter is now a research associate, Genetic Epidemiology Research Unit, Department of Psychiatry, Yale University School of Medicine, New Haven, Conn. Reprint requests to Section on Anxiety and Affective Disorders, Biological Psychiatry Branch, National Institute of Mental Health, 9000 Rockville Pike, Bldg 10, Room 3S-239, Bethesda, MD 20892 (Dr
Uhde).
Arnkoff, PhD;
cerning definition, prevalence, etiology, pathophysiol¬
ogy, assessment, and treatment.4~6 In their review of the social phobia literature, Liebowitz et al6 observed that this disorder has not been viewed by psychopharmacologists as a distinct syndrome worthy of independent study. Consequently, there are few controlled evaluations of treatments of social phobia. The drug that has been most studied for the treatment of social phobia is the monoamine oxidase inhibitor phenelzine sulfate; four controlled drug trials have been conducted that evaluated its effectiveness710 in treating patients with mixed or unspecified phobic conditions. The results of these early drug studies hinted at possible phenelzine efficacy for social anxiety, but limitations in the design of these studies made it difficult to reach de¬ finitive conclusions regarding the therapeutic benefits of monoamine oxidase inhibitor medications in the treat¬ ment of social phobia. Specifically, these older studies treated mixed samples of phobic patients, including patients with social phobia and agoraphobia, and the re¬ sults were not reported by diagnosis, making it impossi¬ ble to determine whether the patients with social phobia, as a separate group, improved at all. These investigations suggested a need for future studies with well-defined subject samples, adequate medication dosages and treat¬ ment duration, more comprehensive assessments, and well-controlled, double-blind designs. Two later trials of phenelzine in samples of patients with pure social phobia yielded additional data that sup¬ ported the efficacy of phenelzine for treatment of these patients. The first, an open pilot study, found that all pa¬ tients who were treated with phenelzine achieved mod¬ erate to marked improvement.11 The second study has been the only well-controlled investigation of phenelzine in a sample of patients with pure social phobia reported to date. In this latter study, Liebowitz and colleagues12 published an interim report of a double-blind, placebocontrolled comparison of phenelzine and atenolol, a ß-adrenergic blocker, in a sample of patients who met DSM-III criteria for social phobia. Preliminary data from this ongoing study have suggested that phenelzine, but not atenolol, may be an effective treatment of social pho¬ bia. However, these findings should be interpreted con-
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servatively, given the interim nature of the report and the presentation of only selected results from newly devel¬ oped outcome measures. Data regarding benzodiazepine treatments of social phobia are minimal. Although case reports13 and open clinical trials14 have suggested that alprazolam, a triazolobenzodiazepine useful in the treatment of panic disor¬ der,15-16 reduces social anxiety, no controlled study inves¬ tigating the effectiveness of alprazolam has been conducted for social phobia. Considered together, these data suggest possible phenelzine and alprazolam efficacy with social phobia. However, given the disparate patient population in the older studies and the preliminary nature and/or relatively small sample size of more recent trials, the value of these agents (ie, phenelzine and alprazolam) as treatments of pure social phobia remains to be established. Relatively few studies of cognitive-behavioral therapies in clinical populations of patients with social phobia have been conducted. The research in this area has focused on the efficacy of cognitive restructuring and exposure tech¬ niques, applied in isolation or as a part of a multicomponent treatment package. Results of these clinical studies have suggested that cognitive restructuring and exposure interventions are effective in the treatment of social anxiety.1725 However, no investigation has been con¬ ducted to establish the relative efficacy of cognitivebehavioral strategies and pharmacological approaches to the treatment of social phobia. The present investigation addressed this question by comparing the effects of a cognitive-behavioral group treatment with pharmacother¬ apy (phenelzine, alprazolam, and pill-placebo) plus in¬ structions for self-directed exposure to phobic stimuli. To our knowledge, this is the first methodologically rigorous investigation that compares pharmacotherapies for social phobia and the first controlled study that compares two pharmacotherapies with psychotherapy for this disorder. PATIENTS AND METHODS
majority of the patients who participated in this investi¬ gation were selected from a pool of respondents to a newspaper article in the "Health Section" of the Washington Post that described social phobia and a research program for its treatment The
at the National Institute of Mental Health, Bethesda, Md. Oth¬ ers came from a variety of referral sources, including other units at the National Institute of Mental Health and private practitio¬ ners. To be considered for participation, subjects had to be aged 18 to 60 years, free of medications, or able to discontinue any medications other than oral contraceptives, and willing to accept random assignment to treatment in a double-blind procedure. Prospective patients were sent a screening packet that contained of the program and two screening measures a brief
description for social phobia. Treatment applicants who reported subjec¬ tively distressing levels of social phobic anxiety and avoidance
either of the screening measures, ie, the Social Phobia Subscale of the Fear Questionnaire26 and the Social Avoidance and Distress Scale,27 were prescreened via telephone by one of us (C.S.G.). Eligible candidates for the treatment program were in¬ vited to the National Institute of Mental Health for a structured diagnostic interview. In the next phase of the screening process, the patients were evaluated by one of two clinical psychology doctoral candidates with the use of the Anxiety Disorders Interview ScheduleRevised28 and a modified form of the Schedule for Affective Dis¬ orders and Schizophrenia-Lifetime version.29 Criteria for inclu¬ sion were a primary diagnosis of social phobia by DSM-111 criteria and good physical health. Criteria for exclusion were (1) DSMon
diagnosis of major depression, melancholic subtype; (2) pregnancy or the intention to become pregnant during the 6 months of the study; (3) a history of psychosis; (4) an active sub¬ stance abuse problem; (5) presence of a medical condition that would contraindícate treatment with alprazolam or phenelzine; and (6) an inability to comply with rigorous protocol require¬ ments, including drug and dietary restrictions. Patients were not permitted to be in concurrent psychotherapy while they were participating in this protocol. Sixty-five patients were admitted to the active phase of the study, and 59 completed the treatment program and the follow-up assessment. Forty-eight patients (74%) had chief complaints of anxiety and avoidance of specific social situations. Seventeen patients (26%) complained of more generalized and pervasive social fears. Patients were classified as having specific social phobia if their main fear (the phobic situation for which they sought treatment) involved one or two of the following ac¬ tivities: public speaking, eating in public, writing while they were being observed, or using a public rest room. Those patients who reported fears of interacting in most social situations were designated as having generalized social phobia. This subtyping is consistent with DSM-III-R criteria. Differences among the treatment groups in distributions of these fears were not signif¬ Ill
icant.
and 41 women (63%), (SD, 9.6 years; age range, 18 to 60 years). Fifty-nine patients (91%) were white, and six (9%) were black or other minority. There were 32 married patients (49%), 29 single patients (45%), and four divorced or widowed patients (6%). Forty-two patients (64%) had at least a college education, with 16 patients (24%) having also completed graduate or pro¬ fessional training. Fourteen patients (22%) had completed some college, and seven patients (11%) had completed no higher ed¬ ucation after high school. Two patients (3%) had not completed secondary school. Forty-eight patients (74%) were employed full-time, and five patients (8%) worked part-time. Twelve patients (18%) were not employed. There were no statistically The with a
sample comprised 24 men (37%)
mean
age of 36.5 years
significant differences among treatment groups on any of these demographic variables by 2 test results. Although 27 patients (42%) had a history of major depression, only nine patients (14%) had affective disturbances (ie, dysthy¬ mic disorder) at the time of this study, and no patients currently met criteria for major depression. Several patients, however, met criteria for an additional DSM-III anxiety disorder, including generalized anxiety disorder (n 19 [29% ]), panic disorder (n 3 [5%]), and panic disorder with agoraphobia (n 1 [2%]). Thirtyeight patients (58%) had received prior treatment of their psychiatric conditions. There were no significant differences =
=
=
among treatment groups in terms of these characteristics, except for a significantly greater number of patients who had experi¬ enced a spontaneous panic attack in their lifetime in the phenelzine-treated group and significantly fewer patients who had previously sought treatment in the cognitive-behavioral therapy group.
Treatments
Subjects were randomly assigned to one of four treatment conditions: (1) cognitive-behavioral therapy, (2) pharmacother¬ apy with phenelzine and instructions for self-exposure to pho¬ bic stimuli, (3) pharmacotherapy with alprazolam and instruc¬ tions for exposure, or (4) pill-placebo and instructions for exposure. Treatment assignments were made following com¬ pletion of the pretest assessment. Fifteen subjects were assigned to each of the drug and placebo conditions, and 20 were assigned to the cognitive-behavioral therapy group. The difference in treatment group sizes resulted from a stratified randomization schedule (ie, one that assigned more patients to cognitivebehavioral therapy early in the subject selection process) that was designed to expedite the initiation of two 10-patient cognitive-behavioral therapy groups. Each of the treatments was 12 weeks in duration, and all patients were seen once weekly.
Downloaded From: http://archpsyc.jamanetwork.com/ by a New York University User on 06/08/2015
Subjects in the active medication and placebo conditions were seen individually, while subjects in the cognitive-behavioral therapy condition were treated in a group format. At the first and fourth treatment sessions, all patients made ratings of treatment credibility and outcome expectancy using the Reactions to Treatment Questionnaire,30 a measure that comprised a series of 10-point scales with higher numbers indi¬ cating greater credibility or more positive outcome expectancies. Analyses of variance (ANOVAs) of items from the Reactions to
Treatment Questionnaire revealed that the four treatment groups did not show important statistical differences in their as¬ sessments of treatment credibility and outcome expectancy. It appeared, therefore, that the drug and cognitive-behavioral treatments were presented in a credible fashion and that patients in both the drug and cognitive-behavioral conditions held high expectancies for improvement. Thus, any resultant differences among groups on outcome measures were not likely to be due to credibility or expectancy effects.
Cognitive-Behavioral Therapy.—The cognitive-behavioral therapy condition was conducted in a group format by a team that comprised two clinical psychologists with postdoctoral training in cognitive therapy and experience in treating anxiety disorders. Two groups of 10 patients each met weekly for 2-hour sessions that were run according to a detailed social phobia treatment manual.30 Major treatment components were cognitive-restructuring techniques, in-session-simulated social exposures, and personalized homework assignments that re¬ quired both the use of cognitive-restructuring techniques and real-life exposure to previously avoided social situations. Ther¬ apists were oriented to the treatment protocol by an experienced cognitive therapist (D.B.A.), who remained available for con¬ sultation throughout the treatment program. All group sessions were audiotaped so that a manipulation check could later be performed. Two of us (C.S.G. and D.B.A.) monitored a sample
of these tapes to assess adherence to the treatment manual. Drug Treatments.—Medications were prescribed on an indi¬ vidual basis in a double-blind procedure by one of three psychi¬ atrists (M.E.T., B.J.V., and T.W.U.) who met weekly with each subject for 15- to 30-minute sessions. During the weekly sessions, physicians made ratings of patients' symptoms and impairment, adjusted medication doses, and firmly encouraged patients to push themselves into phobic situations. The physician's adher¬ ence to the treatment protocol was monitored by one of us (C.S.G.) who periodically observed or audiotaped patient visits to check that patients received nonspecific, supportive contacts with a focus on encouragement to engage in exposure. Subjects took medication four times daily on a fixed dosage schedule. Dos¬ ages began at 0.7 mg/d of alprazolam and 10 mg/d of phenelzine sulfate and were increased within 4 weeks to a maximum of 6.3 mg/d of alprazolam or 90 mg/d of phenelzine sulfate. Placebos and active medications were prepared by the pharmacy at the Na¬ tional Institutes of Health, Bethesda, Md, in identical capsules. The pharmacy staff established and maintained the key to the medication blind. Dosages were increased until all social phobic symptoms had disappeared, until side effects precluded further increases, or until the maximum dosage was reached. The mean dose of alprazolam prescribed was 4.2 mg/d (SD, 1.3 mg/d; range, 2.1 to 6.3 mg/d), and the mean dose of phenelzine sulfate pre¬ scribed was 55 mg/d (SD, 16 mg/d; range, 30 to 90 mg/d). At the end of the 12th week, capsules were tapered and discontinued according to a planned 4-week dosage-dependent schedule, al¬ though the blinded physicians were allowed to adjust the rate of taper according to their clinical discretion (range, 2 to 5 weeks). Response to the taper schedule was variable; only one patient ex¬ perienced withdrawal symptoms to an extent that warranted dis¬ charge on medication. No other patients reported symptoms of withdrawal at follow-up.
Assessment of Outcome
Scales.—Subjects were assessed at pretest (baseline), weekly during the treatment phase, at posttest (during the 12th week of
treatment before discontinuation of treatment), and at
follow-up
(2 months following discontinuation of treatment). This report will focus on pretest, posttest, and follow-up data from selfreport and physician-rated measures of social phobic and related
symptoms and of overall functioning. The
self-report measures were the Social Avoidance and Dis¬
Scale,27 Fear of Negative Evaluation Scale,27 Fear Question¬ naire,26 21-item Beck Depression Inventory,31 the State and Trait tress
forms of the Spielberger State-Trait Anxiety Inventory,32 the So¬ cial Interaction Self-Statement Test,33 and the Work and Social Disability Scale.34 The Social Avoidance and Distress Scale
0 to 28) and Fear of Negative Evaluation Scale (range, 0 30) were developed to measure the experience of anxiety and
(range, to
avoidance of social situations and the fear of being evaluated negatively by others. The Fear Questionnaire (range of the So¬ cial Phobia Subscale, 0 to 40) was designed to measure change in severity of phobic avoidance and distress. The 21-item Beck Depression Inventory (range, 0 to 63) measures manifestations of depression. The State and Trait forms of the Spielberger State-Trait Anxiety Inventory, both with a range of 20 to 80, measure state and trait anxiety. The Social Interaction SelfStatement Test assesses how frequently subjects make certain facultative and inhibiting self-statements during social interac¬ tions. It yields separate scores (range, 15 to 75) for positive and negative self-statements. The Social Interaction Self-Statement Test was administered at pretest and posttest immediately after a behavioral assessment that involved exposure to the patient's target phobic situation (eg, giving a speech, informal conversa¬ tion with a stranger, writing while observed). With the exception of the Social Interaction Self-Statement Test, patients completed this self-report battery at pretest, posttest, and follow-up. The physician-rated measure was the Work and Social Disability Scale,34 a five-point measure of symptoms and related impair¬ ment in work and social functioning (1 no disability, 2 mild, 3 moderate, 4 marked, and 5 severe). It was rated by the treating physicians at pretest, posttest, and follow-up during routine pharmacotherapy sessions. Analyses.—Three statistical methods were utilized to assess treatment effects as follows: (1) Outcome was assessed by anal¬ yses of covariance (ANCOVAs), with pretest scores serving as the covariate, to examine differential effects among the four treatment conditions.35 (2) To investigate treatment response across time within groups, repeated-measures ANOVAs were performed on the physician and patient-rated scales. (3) Finally, the patients were categorized as "responders" vs "nonre¬ sponders" after treatment according to whether subjects were below or above the mean (ie, 8.8) for the general population on the Social Phobia Subscale of the Fear Questionnaire.36-37 The Fear Questionnaire was chosen retrospectively to dichotomize the patients into responders and nonresponders because this measure has been found to be a valid and reliable measure of social phobic symptoms and accurately reflects change in re¬ sponse to treatment.26 Conservative Huynhfeldt probabilities were used for all ANOVAs, and post hoc analyses employed Bonferroni's t test. Bonferroni's f test is used for within-experiment tests. Post hoc comparisons are at the protected type 1 error of 5%. All proba¬ bilities less than .05 are considered to be significant, although selected probabilities less than .10 are presented in the written text or tables. =
=
=
=
=
RESULTS Of the 65 patients admitted, six (9.2%) failed to complete the treatment program. Three subjects (15%) in the cognitivebehavioral therapy group and three (6.7%) in a drug condition (two in the phenelzine-treated group and one in the alprazolamtreated group) terminated early. Of the patients in the cognitivebehavioral therapy group who dropped out, two terminated within the first 2 weeks of treatment because they did not per¬ ceive the treatment as appropriate for their problems, and one withdrew because his father was terminally ill. The patient in the
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Scale Social Avoidance and Distress
Total Fear QuestionnaireSocial Phobia
Pretest,
Posttest,
No.
Mean (SD)
Mean (SD)
Mean (SD)
AL
12 13
PP
15
18.0 (7.9)
17
18.2(9.3)
57
17.9(8.1),
10.2
15.7(5.5) 8.3 (6.2) 13.3 (8.8) 11.8(8.9) 12.2(7.9)b
(2,106) 49.2 (3,53)=1.63 (6,106)=1.0
CBT
10.7(7.9) 6.5 (6.3) 11.0 (7.4) 12.1 (8.7)
