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

Launched by BOSTON UNIVERSITY CHARLES RIVER CAMPUS · Jan 5, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether researchers can predict which adults with social anxiety disorder (SAD) will benefit from treatment. The study involves recruiting 190 adults aged 18 to 50 who struggle with severe social anxiety. Participants will undergo brain scans before and after a 12-week program of group cognitive behavioral therapy (CBT), a type of therapy that helps change unhelpful thoughts and behaviors. If some individuals do not show enough improvement from group therapy, they may be offered an additional 12 weeks of one-on-one therapy combined with medication.

To take part in the study, individuals need to have a specific level of anxiety, as measured by a questionnaire, and be willing to follow the study's guidelines. The trial is also including a comparison group of 50 adults who do not have social anxiety. This will help researchers understand the differences in brain activity and treatment responses between those with and without SAD. It’s important to note that certain individuals, such as those with specific mental health conditions or serious medical issues, may not be eligible for participation. Overall, this trial aims to improve treatment for social anxiety by understanding how different people respond to therapy.

Gender

ALL

Eligibility criteria

• Inclusion criteria for all participants:
• • (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:
• • 1. 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.
• • 2. Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3.
• • 3. Medical history interview and laboratory findings without clinically significant abnormalities.
• • 4. Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.
• Exclusion criteria:
• • 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, 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.
• • 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, braces, or claustrophobia.