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Computer-Based Treatment for Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

computer-based treatment

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring SAD, Social Anxiety, Social Phobia

Eligibility Criteria

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

Sites / Locations

New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

4-week computer-based treatment

8-week 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.

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.

Outcomes

Primary Outcome Measures

Change in Percent Dwell Time on Threat Faces

Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline.

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.

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).

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.

Change in Total Score of the Revised Social Anhedonia Scale

40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia)

Change in Total Score of the Snaith Hamilton Pleasure Scale

Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)

Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version

Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).

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

NCT ID

NCT03415022

First Posted

January 22, 2018

Last Updated

March 31, 2022

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT03415022

Brief Title

Computer-Based Treatment for Social Anxiety Disorder

Official Title

A Novel Computer-Based Treatment for Social Anxiety: Target Engagement

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 30, 2018 (Actual)

Primary Completion Date

March 31, 2020 (Actual)

Study Completion Date

March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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)

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Anxiety Disorder

Keywords

SAD, Social Anxiety, Social Phobia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Computer-based task involving free viewing of faces and listening to music

Masking

Outcomes Assessor

Masking Description

Outcomes assessor will not be informed as to whether a participant is randomized to 4 or 8 weeks of treatment.

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4-week 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

8-week computer-based treatment

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

computer-based treatment

Intervention Description

30 minute sessions of free viewing of faces and listening to music

Primary Outcome Measure Information:

Title

Change in Percent Dwell Time on Threat Faces

Description

Time Frame

baseline to week 8

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

Baseline to week 8

Secondary Outcome Measure Information:

Title

Change in Total Score of Social Phobia Inventory (SPIN)

Description

Time Frame

baseline to week 8

Title

Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire

Description

Time Frame

baseline to week 8

Title

Change in Total Score of the Revised Social Anhedonia Scale

Description

Time Frame

baseline to week 8

Title

Change in Total Score of the Snaith Hamilton Pleasure Scale

Description

Time Frame

baseline to week 8

Title

Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version

Description

Time Frame

baseline to week 8

Title

Clinical Global Impression-Change Scale

Description

Time Frame

week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

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

New York State Psychiatric Institute

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 generate a Global Unique Identifier (GUID) for each participant. The key clinical rating scale measures (LSAS, SPIN, QLESQ, HRSD) are all included.

IPD Sharing Time Frame

Raw data will be submitted semi-annually every January 15 and July 15.

IPD Sharing Access Criteria

see URL below for criteria

IPD Sharing URL

https://nda.nih.gov/

Citations:

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Citation

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Citation

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PubMed Identifier

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Citation

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Computer-Based Treatment for Social Anxiety Disorder

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