Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
1 other identifier
interventional
240
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 19, 2025
February 1, 2025
3.5 years
December 19, 2022
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (8)
Change in Clinical Global Impression Severity scale (CGI-S)
Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders
Social Phobia Inventory (SPIN)
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)
Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders
Social Network Index (SNI)
Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders
Patient Health Questionnaire-9 (PHQ-9)
Weekly up through week 12, and weekly from weeks 14-25
- +3 more secondary outcomes
Other Outcomes (3)
Social Cost Questionnaire (SCQ)
Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders
Kaufman Brief Intelligence Test (KBIT)
Week 0
Credibility/Expectancy Questionnaire (CEQ)
Week 0
Study Arms (3)
Responders
EXPERIMENTALThe experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder.
Non-Responders
EXPERIMENTALThe 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.
Controls
NO INTERVENTIONControls 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.
Interventions
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.
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 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.
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
Eligibility Criteria
You may qualify if:
- (1) Any gender or race between 18-50 years old.
- (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).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston University Charles River Campuslead
- Massachusetts Institute of Technologycollaborator
- Mclean Hospitalcollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, 02115, United States
Related Publications (3)
Bush G, Shin LM, Holmes J, Rosen BR, Vogt BA. The Multi-Source Interference Task: validation study with fMRI in individual subjects. Mol Psychiatry. 2003 Jan;8(1):60-70. doi: 10.1038/sj.mp.4001217.
PMID: 12556909BACKGROUNDDelgado MR, Nystrom LE, Fissell C, Noll DC, Fiez JA. Tracking the hemodynamic responses to reward and punishment in the striatum. J Neurophysiol. 2000 Dec;84(6):3072-7. doi: 10.1152/jn.2000.84.6.3072.
PMID: 11110834BACKGROUNDTottenham N, Tanaka JW, Leon AC, McCarry T, Nurse M, Hare TA, Marcus DJ, Westerlund A, Casey BJ, Nelson C. The NimStim set of facial expressions: judgments from untrained research participants. Psychiatry Res. 2009 Aug 15;168(3):242-9. doi: 10.1016/j.psychres.2008.05.006. Epub 2009 Jun 28.
PMID: 19564050BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Gabrieli, PhD
Massachusetts Institute of Technology
- PRINCIPAL INVESTIGATOR
Daniel Dillon, PhD
Mclean Hospital
- PRINCIPAL INVESTIGATOR
Anthony Rosellini, PhD
Boston University Charles River Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- N/A--no masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 19, 2022
First Posted
January 13, 2023
Study Start
May 26, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
February 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- In accordance with NIMH policies, these data will be made available within twelve months of database lock or following publication of primary manuscript, whichever occurs first.
- Access Criteria
- Access criteria will align with requirements for access to NDCT and other NIMH databases.
REDCap will create appropriately de-identified databases according to guidelines provided by the NIH and research data sharing practices. A de-identified dataset can be readily shared without the need of a Data Use Agreement (DUA) and facilitates book-keeping, making it the preferred data sharing plan. All study data will be made available via a data archive accessible through a public website hosted by McLean, BU, and/or MIT. Web archived data may also be available as downloadable content. Our data sharing policies and capabilities will follow published NIH standards relating to data sharing. Access to databases generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate. Further, all de-identified data will be shared with appropriate permissions with the National Database for Clinical Trials related to Mental Illness (NDCT), and thus available for all researchers.