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Computer-Based Treatment for Social Anxiety Disorder

N

New York State Psychiatric Institute

Status

Completed

Conditions

Social Anxiety Disorder

Treatments

Behavioral: computer-based treatment

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The present study is an open 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 "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed 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

41 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females between the ages of 18 and 60
  • Current primary diagnosis of SAD
  • Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
  • Fluent in English and willing and able to give informed written consent and 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 posttraumatic 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 allowed)
  • Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
  • Any concurrent cognitive behavioral therapy; 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 (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
  • Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

41 participants in 2 patient groups

4-week 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
8-week computer-based treatment
Experimental group
Description:
An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
Treatment:
Behavioral: computer-based treatment

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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