Clinical trial NCT04663724: Computer - Based Treatment for Social Anxiety Disorder
Official title: Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Attention
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Mclean Hospital
name: Tel Aviv University
name: National Institute of Mental Health (NIMH)
First posted: 2020-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

  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)

Primary outcomes:
measure: Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
timeFrame: From baseline up to Month 4
measure: Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
timeFrame: From baseline up to Month 4
Secondary outcomes:
measure: Change in Total Score of Social Phobia Inventory (SPIN)
timeFrame: Baseline to Month 4
measure: Clinical Global Impression-Change Scale
timeFrame: Baseline to Month 4
Other outcomes:
Locations:
city: New York
country: United States
facility: 1051 Riverside Drive
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: FRANKLIN SCHNEIER, MD
role: PRINCIPAL_INVESTIGATOR
References: