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OpenTrials
Completed

NCT Number: NCT03415022

Computer-Based Treatment for Social Anxiety Disorder

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)

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Computer-Based Treatment

Behavioral

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

Primary outcomes

  1. Change in Percent Dwell Time on Threat Faces

    Time frame: baseline to week 8

    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.

  2. Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)

    Time frame: Baseline to week 8

    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 outcomes

  1. Change in Total Score of Social Phobia Inventory (SPIN)

    Time frame: baseline to week 8

    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).

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

    Time frame: baseline to week 8

    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.

  3. Change in Total Score of the Revised Social Anhedonia Scale

    Time frame: baseline to week 8

    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)

  4. Change in Total Score of the Snaith Hamilton Pleasure Scale

    Time frame: baseline to week 8

    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)

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

    Time frame: baseline to week 8

    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).

  6. Clinical Global Impression-Change Scale

    Time frame: week 8

    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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2018
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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