Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety (NCT05683223) | Clinical Trial Compass
RecruitingNot Applicable
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
United States240 participantsStarted 2023-05-26
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Clinical Global Impression-Improvement Scale (CGI-I)
Timeframe: 6 weeks, 12 weeks, 19 and 25 weeks for non-responders
2
Change in Liebowitz Social Anxiety Scale (LSAS)
Timeframe: Before Week 0, 6 weeks, 12 weeks, 19 and 25 weeks for non-responders
✕. 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.