[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491752":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":56,"locations":65,"responsibleParty":84,"collaborators":87,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":24,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":24,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Boston University Charles River Campus","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Responders","EXPERIMENTAL","The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder.",[13],"Behavioral: Group CBT for Social Anxiety Disorder",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-Responders","The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder. Non-responders to initial exposure therapy will receive sertraline and additional exposure therapy prior to final EEG and MRI.",[13,18,19],"Drug: Sertraline","Behavioral: Individual CBT for Social Anxiety Disorder",{"label":21,"type":22,"description":23,"interventionNames":24},"Controls","NO_INTERVENTION","Controls will receive baseline EEG and MRI, screening questionnaires and intake interview. They will not participate in therapy but complete weekly symptom measures and a second EEG\u002FMRI session 12 weeks after baseline. Control participants will be compared with social anxiety participants to determine differences in neuro-markers at baseline and over follow-up.",null,[26,33,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Group CBT for Social Anxiety Disorder","Initial 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.",[15,9],[32],"SAD Group",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Sertraline","Non-responders will initiate sertraline at baseline (week 0) with 25 mg\u002Fday followed by a dose increase to 50 mg\u002Fday 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\u002Fday 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\u002Fday of sertraline due to side effects will be maintained in the trial if they are on at least 50 mg\u002Fday by week 8; all symptomatic participants will be titrated to their maximally tolerated dose (\\\u003C 200 mg\u002Fday sertraline). Any participant unable to tolerate sertraline will be discontinued and referred for clinical treatment.",[15],[39],"Non-responder Meds",{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Individual CBT for Social Anxiety Disorder","Participants 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",[15],[45],"Non-responder CBT",[47,51,54],{"name":48,"affiliation":49,"role":50},"John Gabrieli, PhD","Massachusetts Institute of Technology","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":53,"role":50},"Daniel Dillon, PhD","Mclean Hospital",{"name":55,"affiliation":5,"role":50},"Anthony Rosellini, PhD",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":24,"email":61},"Anthony J Rosellini, PhD","CONTACT","617-353-9610","ajrosell@bu.edu",{"name":63,"role":59,"phone":60,"phoneExt":24,"email":64},"Amanda Desmarais, MA","amanda99@bu.edu",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Center for Anxiety and Related Disorders at Boston University","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-71.05977,42.35843,{"lat":78,"lon":77},[81,82],{"name":55,"role":59,"phone":60,"phoneExt":24,"email":61},{"name":83,"role":59,"phone":60,"phoneExt":24,"email":64},"Amanda Desmarais, PhD",{"type":50,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Anthony J. Rosellini","Associate Professor",[88,89,90],{"name":49,"class":6},{"name":53,"class":6},{"name":91,"class":92},"National Institute of Mental Health (NIMH)","NIH","100491752","neural-markers-of-treatment-mechanisms-and-prediction-of-treatment-outcomes-in-social-anxiety-100491752",false,"NCT05683223","Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety","Inclusion criteria for all participants:\n\n(1) Any gender or race between 18-50 years old.\n\nAdditional inclusion criteria for healthy controls:\n\n(1) Liebowitz Social Anxiety Scale (LSAS; Mennin et al., 2002) score \\\u003C= 30, does not currently meet criteria for an Axis I psychiatric condition, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; American Psychiatric Association, 2013).\n\nAdditional inclusion criteria for the social anxiety disorder (SAD) group:\n\n1. 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.\n2. Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3.\n3. Medical history interview and laboratory findings without clinically significant abnormalities.\n4. Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.\n\nExclusion criteria:\n\n1. 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.\n2. . 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.\n3. 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.\n4. Significant personality dysfunction likely to interfere with study participation.\n5. Serious medical illness, associated treatment, or other instability for which hospitalization may be likely within the next year, or which may alter fMRI or EEG measurements. Participants with a history of serious medical illness or treatments that may alter fMRI measurements may enroll in the study 12 months after the condition has been remitted and ending treatment.\n6. Patients with a current or past history of seizures.\n7. Pregnant women, lactating women, and women of childbearing potential who may become pregnant.\n8. Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the social anxiety is excluded. Individuals with prior CBT experience or treatments that included cognitive and behavioral skills and exposure procedures (e.g., assertiveness and social skills trainings) will be excluded. General supportive or insight-oriented therapy initiated \\> 3 months prior is acceptable.\n9. Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment).\n10. Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.\n11. Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, braces, or claustrophobia.",true,"ALL","18 Years","50 Years",{"count":104,"type":105},240,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.\n\nData 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.",[111],"Social Anxiety Disorder",[113,114,115,116,117,118,119,120,121,122,123],"social anxiety disorder","sertraline","exposure therapy","social cost","MRI","EEG","structural connectivity","functional connectivity","cognitive control system","positive valence system","negative valence system","2026-05-14",{"date":126,"type":127},"2026-05-18","ACTUAL",{"date":129,"type":127},"2023-05-26",{"date":131,"type":105},"2027-06-30",{"name":5,"class":6},1]