Computer - Based Treatment for Social Anxiety Disorder

New York State Psychiatric Institute

Status: Suspended

Conditions: Social Anxiety Disorder

Treatments: Behavioral: Computer-Based Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04663724

8072

5R33MH116089-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Experimental Computer-Based Treatment

Experimental group

Description:

A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.

Treatment:

Behavioral: Computer-Based Treatment

Comparator Computer-Based Treatment

Active Comparator group

Description:

A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.

Treatment:

Behavioral: Computer-Based Treatment