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Sertraline + CBT for Social Anxiety Disorder

N/A

Recruiting

Led By Daniel Dillon, PhD

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks, 19 and 25 weeks for non-responders

Awards & highlights

Study Summary

This trial seeks to find out if brain imaging can predict SAD treatment response & if individual CBT + sertraline can help SAD adults who don't respond to group CBT.

Who is the study for?

Adults aged 18-50 with severe social anxiety can join this trial. Exclusions include those with bipolar, schizophrenia, recent substance abuse, significant suicidal thoughts or actions, unstable serious medical conditions, pregnancy, and certain metal implants that interfere with MRI scans.Check my eligibility

What is being tested?

The study is testing if brain imaging before and after group CBT can predict treatment success in social anxiety disorder. Non-responders to group therapy may receive individual CBT plus sertraline (an SSRI medication).See study design

What are the potential side effects?

Sertraline might cause nausea, sleep issues, tremors or dizziness. CBT generally has no side effects but could temporarily increase anxiety levels as patients confront their fears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks, 19 and 25 weeks for non-responders

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks, 19 and 25 weeks for non-responders

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks, 19 and 25 weeks for non-responders for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Clinical Global Impression-Improvement Scale (CGI-I)

Change in Liebowitz Social Anxiety Scale (LSAS)

Secondary outcome measures

Change in Clinical Global Impression Severity scale (CGI-S)

Changes in the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

General Anxiety Disorder-7 (GAD-7)

+5 more

Other outcome measures

Credibility/Expectancy Questionnaire (CEQ)

Kaufman Brief Intelligence Test (KBIT)

Social Cost Questionnaire (SCQ)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: RespondersExperimental Treatment1 Intervention

The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder.

Group II: Non-RespondersExperimental Treatment3 Interventions

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.

Group III: ControlsActive Control1 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/MRI 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sertraline

2002

Completed Phase 4

~5470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor

114 Previous Clinical Trials

12,050 Total Patients Enrolled

Massachusetts Institute of TechnologyOTHER

97 Previous Clinical Trials

12,729,747 Total Patients Enrolled

Mclean HospitalOTHER

213 Previous Clinical Trials

21,454 Total Patients Enrolled

Media Library

Group CBT for Social Anxiety Disorder Clinical Trial Eligibility Overview. Trial Name: NCT05683223 — N/A

Social Anxiety Disorder Research Study Groups: Controls, Non-Responders, Responders

Social Anxiety Disorder Clinical Trial 2023: Group CBT for Social Anxiety Disorder Highlights & Side Effects. Trial Name: NCT05683223 — N/A

Group CBT for Social Anxiety Disorder 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683223 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research permit people aged seventy and above to participate?

"This trial is exclusively open to individuals aged 18-50. There are 118 studies for minors and 298 trials available that cater to those who exceed 65 years of age."

Answered by AI

Is enrollment for this experiment currently open?

"Per the details found on clinicaltrials.gov, this medical investigation is actively receiving applications. It was first advertised to the public on June 1st 2023 and its last update occurred 8 days later, in accordance with a prior post from 6/9/2023."

Answered by AI

Does my eligibility meet the requirements of participating in this examination?

"This experimental intervention is seeking to enroll 240 adults, aged 18-50 years old, who suffer from social anxiety disorder. Selected participants must meet the following criteria: (1) gender and race of any combination between 18-50 years old., (2) Liebowitz Social Anxiety Scale score no higher than 30 points, without meeting DSM-5 Axis I psychiatric conditions., Outpatients with a primary complaint of fear during social interactions as indicated by an LSAS score greater or equal to 60 points., A moderate level of clinical severity signalled through a CGI-S rating at least 3 out of 7., Physically healthy according to medical history"

Answered by AI

What are the principal goals of this investigation?

"The main outcome that will be evaluated through this trial over a series of 0, 6, 12, 19 and 25 weeks for non-responders is structured clinical interviews of DSM-5 (SCID-5). Secondary objectives include General Anxiety Disorder-7 (GAD-7), Social Phobia Inventory (SPIN) and Quality Of Life Enjoyment And Satisfaction Questionnaire Short Form (Q-LES-QSF). GAD measures weekly anxiety symptoms with scores higher or equal to 5 indicating clinical levels ranging from 'not at all' to 'nearly every day'. SPIN evaluates social anxiety disorder on a scale of 0 -"

Answered by AI

What is the overall participant count of this research endeavor?

"Confirmed. According to clinicaltrials.gov, this investigation is accumulating participants since its launch on June 1st 2023 and has been recently updated on June 9th 2023. It requires 240 volunteers at a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety

Anthony J. Rosellini 2023. "Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05683223.

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