Computer - Based Treatment for Social Anxiety Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computer-Based Treatment.
- Who it may be relevant to
- Registry conditions: Social Anxiety Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial
Overview
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
- Behavioral Computer-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.
Primary outcome measures
- Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) [Time frame: From baseline up to Month 4]
- Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire [Time frame: From baseline up to Month 4]
Secondary outcome measures (2)
- Change in Total Score of Social Phobia Inventory (SPIN) [Time frame: Baseline to Month 4]
- Clinical Global Impression-Change Scale [Time frame: Baseline to Month 4]
Eligibility criteria
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) for at least 3 months
- Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months
- Pregnancy, or plans to become pregnant during the period of the study (will be assessed by urine)
- Contraindication to MRI scanning (Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body)
- pacemaker
- paramagnetic metallic prosthesis
- surgical clips
- shrapnel
- necessity for constant medicinal patch
- some tattoos
- Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- 1051 Riverside Drive — New York
Identifiers
NCT: NCT04663724 · 8072 · 5R33MH116089-04