Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible 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) 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) 1. pacemaker 2. paramagnetic metallic prosthesis 3. surgical clips 4. shrapnel 5. necessity for constant medicinal patch 6. some tattoos - Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental Computer-Based Treatment
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
  • 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.
Active Comparator
Comparator Computer-Based Treatment
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
  • 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.

Recruiting Locations

1051 Riverside Drive
New York, New York 10032

More Details

Status
Recruiting
Sponsor
New York State Psychiatric Institute

Study Contact

Franklin Schneier, MD
6467748041
franklin.schneier@nyspi.columbia.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.