The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Adults in the SAD group who do not respond enough to group CBT may be offered the opportunity to complete an additional 12 weeks of individual CBT while receiving SSRI medication (sertraline, see below) for SAD.
Data collected from participants who experience anxiety will be compared to a group of 50 participants with little or no social anxiety, who will serve as a comparison group.
Outpatients with a primary psychiatric complaint (designated by the patient as the most important source of current distress) of social anxiety with social interaction fear as defined by an Liebowitz Social Anxiety Scale (LSAS) score >= 60.
Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3.
Medical history interview and laboratory findings without clinically significant abnormalities.
Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.
A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, intellectual disability, or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol, marijuana, and stimulant use during the acute period of study participation.
. Patients with significant suicidal ideation Montgomery-Åsberg Depression Rating Scale (10 items, self-report) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
Patients can be taking a concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers, sertraline), but the dose must be stabilized for at least 2 weeks prior to initiation of randomized treatment.
Significant personality dysfunction likely to interfere with study participation.
Parallel
Group CBT for Social Anxiety Disorder
BehavioralInitial CBT will consist of 12 weekly, 2.5-hour group sessions. Later sessions (after session 7) become more individualized as the exposure practices are tailored to the individual participant's concerns. Most often, the exposures are completed outside the group environment. Session content includes various cognitive behavioral strategies tailored to SAD, such as psychoeducation, examining and challenging cognitive distortions, and exposure exercises.
Sertraline
DrugNon-responders will initiate sertraline at baseline (week 0) with 25 mg/day followed by a dose increase to 50 mg/day at week 1, 100 mg at week 4, 150 mg at week 6, and 200 mg at week 8. Upward dose titration may be slowed and the dose decreased if necessary due to side effects, but the clinician will attempt to titrate all symptomatic participants up to 200 mg/day if tolerated by week 8, with the last dose increase allowed at week 10. Participants will be assessed at each visit by the study psychiatrist for purposes of dose titration and monitoring. Symptomatic participants unable to reach 200 mg/day of sertraline due to side effects will be maintained in the trial if they are on at least 50 mg/day by week 8; all symptomatic participants will be titrated to their maximally tolerated dose (\< 200 mg/day sertraline). Any participant unable to tolerate sertraline will be discontinued and referred for clinical treatment.
Individual CBT for Social Anxiety Disorder
BehavioralParticipants who show no or only partial response to the initial group CBT will continue with an individual, tailored form of CBT plus adjunctive SSRI. The format of CBT will include
Change in Clinical Global Impression-Improvement Scale (CGI-I)
The CGI-S is a 7-point scale that requires the clinician to rate the improvement of the patient's illness at the time of assessment compared to baseline. To aid CGI scoring, the clinician will use the Social Phobic Disorders Severity and Change Form (SPD-SC). Treatment responder status will be defined as a CGI-I score of 1 (very much improved) or 2 (much improved)
Change in Liebowitz Social Anxiety Scale (LSAS)
The LSAS is a questionnaire developed by Dr. Michael R. Liebowitz, a psychiatrist and researcher. This measure assesses the way that social phobia plays a role in the participant's life across a variety of situations. LSAS greater than or equal to 60 meets criteria for inclusion in the treatment group.
Change in Clinical Global Impression Severity scale (CGI-S)
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Ratings range from 1 (normal) to 7 (most extremely ill patients). CGI-S greater than or equal to 3 meets criteria for inclusion in SAD treatment group.
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (abbreviated as SPIN ) is a 17-item questionnaire developed by the Psychiatry and Behavioral Sciences Department at Duke University. Each item is rated 0 (not at all) to 4 (extremely). It is effective in screening for, and measuring the severity of social anxiety disorder.
The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a 16-item self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The measure rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction on a scale from 1 (very poor) to 5 (very good).
Social Network Index (SNI)
The 12-item SNI questionnaire assesses 12 types of social relationships. This measure will be included in secondary exploratory analyses as a baseline measure for change with treatment. Assessment scores are summed with 0 being the most isolated, and 2, 3, and 4 forming categorizations of increasing social connectedness.
Social Cost Questionnaire (SCQ)
The SCQ is a 40-item measure that examines a person's assessment of the negative consequences of a social mishap. Each item is scored 0 (not at all) to 8 (extremely). We will administer this questionnaire at each session to examine whether it differentially mediates change with CBT vs. pharmacotherapy.
Kaufman Brief Intelligence Test (KBIT)
The Kaufman Brief Intelligence Test is used to measure verbal and non-verbal intelligence in individuals from ages 4 through 90 years. This measure will be administered at baseline for consideration as a potential moderator of treatment response. Verbal and non-verbal scales are finally scored, standardized for age, and are able to be transformed into an IQ score with a mean of 100 and standard deviation of 15. Overall scores range from 40 to 160, with higher scores indicating a better outcome.
Credibility/Expectancy Questionnaire (CEQ)
The Credibility/Expectancy Questionnaire is the most widely used measure of treatment credibility and expectancy in psychotherapy research. This measure will be administered at baseline as a potential moderator of treatment response. This questionnaire utilizes two scales, 1-9 and 0-100%, with higher scores meaning a better outcome.
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Boston University Charles River Campus
Lead sponsor
Massachusetts Institute of Technology
Collaborator
Mclean Hospital
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
