Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental Computer-Based Treatment
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
Intervention: Computer-Based Treatment (Behavioral)
Comparator Computer-Based Treatment
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
Intervention: Computer-Based Treatment (Behavioral)
Outcomes
Primary Outcomes
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Total Score of Social Phobia Inventory (SPIN)(Baseline to Month 4)
- Clinical Global Impression-Change Scale(Baseline to Month 4)
Investigators
Franklin Schneier
Director, Anxiety Disorders Clinic
New York State Psychiatric Institute