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Computer - Based Treatment for Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-Based Treatment
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Attention

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • 1051 Riverside Drive

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Computer-Based Treatment

Comparator Computer-Based Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety.
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.

Secondary Outcome Measures

Change in Total Score of Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) is a self-rated questionnaire used to assess severity of social anxiety disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety).
Clinical Global Impression-Change Scale
Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.

Full Information

First Posted
December 5, 2020
Last Updated
August 7, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, Mclean Hospital, Tel Aviv University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04663724
Brief Title
Computer - Based Treatment for Social Anxiety Disorder
Official Title
Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
In June 2023 NYSPI decided to undertake an Institute-wide safety review of research protocols that involve human subjects. To support the safety review, NYSPI, paused all ongoing human subjects research studies as of June 12, 2023
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, Mclean Hospital, Tel Aviv University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Computer-Based Treatment
Arm Type
Experimental
Arm Description
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
Arm Title
Comparator Computer-Based Treatment
Arm Type
Active Comparator
Arm Description
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Computer-Based Treatment
Intervention Description
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 Measure Information:
Title
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
Description
Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety.
Time Frame
From baseline up to Month 4
Title
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
Description
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Time Frame
From baseline up to Month 4
Secondary Outcome Measure Information:
Title
Change in Total Score of Social Phobia Inventory (SPIN)
Description
The Social Phobia Inventory (SPIN) is a self-rated questionnaire used to assess severity of social anxiety disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety).
Time Frame
Baseline to Month 4
Title
Clinical Global Impression-Change Scale
Description
Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.
Time Frame
Baseline to Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANKLIN SCHNEIER, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
1051 Riverside Drive
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared through the National Database for Clinical Trials related to Mental Illness (NDCT). We will obtain information needed to generate a Global Unique Identifier (GUID) for each participant (sex, first name, last name, middle name, date of birth, and city/municipality of birth). Raw data will be submitted semi-annually every January 15 and July 15, and prior to the end of each grant.
IPD Sharing Time Frame
Beginning 12 months after completion of study assessments

Learn more about this trial

Computer - Based Treatment for Social Anxiety Disorder

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