Social Anxiety Disorder
Conditions
Keywords
Attention
Brief summary
The present study is a controlled trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)
Detailed description
This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two forms of a recently developed 4-week/8-session computer-based therapy in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).
Interventions
BEHAVIORALComputer-Based Treatment
A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.
Sponsors
New York State Psychiatric Institute
Columbia University
Mclean Hospital
Tel Aviv University
National Institute of Mental Health (NIMH)
University of Texas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between the ages of 18 to 60 * Current primary diagnosis of SAD * Score of at least 50 on the Liebowitz Social Anxiety Scale (self-rated version) * Fluent in English * Willing and able to give informed written consent * Ability to participate responsibly in the protocol * Normal or corrected-to-normal vision
Exclusion criteria
* Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder * Current severe depression * Suicidal ideation or behavior * Current diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder * Current or past organic mental disorder, seizure disorder, epilepsy or brain injury * Current unstable or untreated medical illness * Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders) * Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), buspirone, or zolpidem for sleep for at least 3 months * Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months * Contraindication to MRI scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) | From baseline up to Month 4 | Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety. |
| Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire | From baseline up to Month 4 | Quality of Life Enjoyment \& Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of Social Phobia Inventory (SPIN) | Baseline to Month 4 | The Social Phobia Inventory (SPIN) is a self-rated questionnaire used to assess severity of social anxiety disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety). |
| Clinical Global Impression-Change Scale | Baseline to Month 4 | Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2. |
Countries
United States
Contacts
CONTACTFranklin Schneier, MD
PRINCIPAL_INVESTIGATORFRANKLIN SCHNEIER, MD
New York State Psychiatric Institute
Outcome results
None listed