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Clinical Trial NCT05683223 for Social Anxiety Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Boston University Charles River CampusNeural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety 240
Clinical Trial NCT05683223 is an interventional study for Social Anxiety Disorder that is recruiting. It started on May 26, 2023 with plans to enroll 240 participants. Led by Boston University Charles River Campus, it is expected to complete by June 30, 2027. The latest data from ClinicalTrials.gov was last updated on February 19, 2025.
Brief Summary
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 S...Show More
Detailed Description
The primary aim of this study is to discover neural mechanisms (via EEG and MRI) associated with variation in response to CBT and/or combined CBT and SSRI interventions. The goal is to develop a rigorous model that predicts individual differences in response to treatments using baseline neural markers.
The investigators will recruit 190 adults with social anxiety disorder (SAD) and 50 adult controls. All adults with...
Show MoreOfficial Title
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
Conditions
Social Anxiety DisorderPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
NCT ID Number
Start Date (Actual)
2023-05-26
Last Update Posted
2025-02-19
Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
240
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
social anxiety disorder
sertraline
exposure therapy
social cost
MRI
EEG
structural connectivity
functional connectivity
cognitive control system
positive valence system
negative valence system
sertraline
exposure therapy
social cost
MRI
EEG
structural connectivity
functional connectivity
cognitive control system
positive valence system
negative valence system
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalResponders The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder. | 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 d...Show More |
ExperimentalNon-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. | 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 d...Show More Sertraline Non-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 a...Show More 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 |
No InterventionControls 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
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. | Before Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
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. | Weekly up through week 12, and weekly from weeks 14-25 |
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). | Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
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. | Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a nine-item diagnostic self-report questionnaire which psychologists use to measure the severity of depressive symptoms in patients with mood disorders. This measure will be used to monitor weekly depression symptoms, and scores greater than or equal to 4 indicate clinical levels of depression. Each item is scored on a scale of 0 to 3, with 0 indicating "not at all" and 3 denoting "present nearly every day". The total score range is 0-27. | Weekly up through week 12, and weekly from weeks 14-25 |
General Anxiety Disorder-7 (GAD-7) | The GAD-7 is a seven-item diagnostic self-report questionnaire which psychologists use to measure the severity of anxiety symptoms in patients with mood disorders. This measure will be used to monitor weekly anxiety symptoms, and scores greater than or equal to 5 indicate clinical levels of anxiety. Each item is scored on a scale of 0 to 3, with 0 meaning "not at all" and 3 denoting "present nearly every day". The total score range is 0-21. | Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
Social Anxiety Questionnaire (SAQ) | The SAQ is a 30-item measure of social anxiety consisting of 30 items and five subscales. Each item is rated on a 5-point scale, with a high score indicating a higher social anxiety level. | Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
Changes in the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) | The DIAMOND is a semi-structured interview guide for making the major DSM-5 diagnoses. It is administered by a clinician or trained mental health professional who is familiar with the DSM-5 classification and diagnostic criteria. This measure will be used to determine eligibility for the study in conjunction with other primary outcome measures. | Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
(1) Any gender or race between 18-50 years old.
Additional inclusion criteria for healthy controls:
(1) Liebowitz Social Anxiety Scale (LSAS; Mennin et al., 2002) score <= 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).
Additional inclusion criteria for the social anxiety disorder (SAD) 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.
- 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.
- Patients with a current or past history of seizures.
- Pregnant women, lactating women, and women of childbearing potential who may become pregnant.
- 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.
- 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).
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, braces, or claustrophobia.
Boston University Charles River Campus281 active studies to exploreStudy Responsible Party
Anthony J. Rosellini, Principal Investigator, Associate Professor, Boston University Charles River Campus
Study Central Contact
Contact: Anthony J Rosellini, PhD, 617-353-9610, [email protected]
Contact: Amanda Desmarais, MA, 617-353-9610, [email protected]
1 Study Locations in 1 Countries
Massachusetts
Center for Anxiety and Related Disorders at Boston University, Boston, Massachusetts, 02115, United States
Anthony Rosellini, PhD, Contact, 617-353-9610, [email protected]
Amanda Desmarais, PhD, Contact, 617-353-9610, [email protected]
Recruiting