RECRUITING

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

Conditions

Social Anxiety Disorder sertraline exposure therapy social cost MRI EEG structural connectivity functional connectivity cognitive control system positive valence system negative valence system

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-26

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05683223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. 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. 2. . 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. 3. 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. 4. Significant personality dysfunction likely to interfere with study participation. 5. Serious medical illness or instability for which hospitalization may be likely within the next year. 6. Patients with a current or past history of seizures. 7. Pregnant women, lactating women, and women of childbearing potential who may become pregnant. 8. 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. 9. 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). 10. Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment. 11. Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, or braces.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. 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.
2. . 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.
3. 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.
4. Significant personality dysfunction likely to interfere with study participation.
5. Serious medical illness or instability for which hospitalization may be likely within the next year.
6. Patients with a current or past history of seizures.
7. Pregnant women, lactating women, and women of childbearing potential who may become pregnant.
8. 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.
9. 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).
10. Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
11. Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, or braces.

Contacts and Locations

Study Contact

Kristy N Cuthbert, PhD

CONTACT

617-353-5880

kristync@bu.edu

Emily Coombs

CONTACT

617-353-9610

eacoombs@bu.edu

Principal Investigator

John Gabrieli, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Daniel Dillon, PhD

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Anthony Rosellini, PhD

PRINCIPAL_INVESTIGATOR

Boston University Charles River Campus

Study Locations (Sites)

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

John Gabrieli, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology
Daniel Dillon, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital
Anthony Rosellini, PhD, PRINCIPAL_INVESTIGATOR, Boston University Charles River Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-26

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-05-26

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

social anxiety disorder
sertraline
exposure therapy
social cost
MRI
EEG
structural connectivity
functional connectivity
cognitive control system
positive valence system
negative valence system

Additional Relevant MeSH Terms

Social Anxiety Disorder