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A Novel Computer-Based Therapy for Social Anxiety

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ClinicalTrials.gov Identifier: NCT03240003
Recruitment Status : Suspended (funding unavailable)
First Posted : August 4, 2017
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Franklin Schneier, New York State Psychiatric Institute

Brief Summary:
The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD)

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: GC-MRT Behavioral: modified GC-MRT Behavioral: Non-GC-MRT Not Applicable

Detailed Description:
The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) 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 twice a week for 4 weeks, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using a scan called magnetic resonance imaging (MRI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Novel Computer-Based Therapy for Social Anxiety
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: GC-MRT
Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT
Behavioral: GC-MRT
Group 1 will receive a 4-week (8-sessions) course of GC-MRT

Active Comparator: non-GC-MRT
Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT
Behavioral: Non-GC-MRT
Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT

Experimental: GC-MRT-modified
Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT.
Behavioral: modified GC-MRT
group 3 will receive a 4-week (8-sessions) course of GC-MRT, modified




Primary Outcome Measures :
  1. Liebowitz Social Anxiety Scale [ Time Frame: 4 months ]
    Total score of the Liebowitz Social Anxiety Scale


Secondary Outcome Measures :
  1. Social Phobia Inventory (SPIN) [ Time Frame: 4 months ]
    The Social Phobia Inventory (abbreviated as SPIN) is a self-rated questionnaire that will be 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. Quality of Life Enjoyment & Satisfaction Questionnaire [ Time Frame: 4 months ]
    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. Revised Social Anhedonia Scale [ Time Frame: 4 months ]
    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. Snaith Hamilton Pleasure Scale [ Time Frame: 4 months ]
    Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated 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. Hamilton Rating Scale for Depression - 17 item version [ Time Frame: 4 months ]
    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: 4 months ]
    Clinical Global Impression-Change Scale: A quickly administered and widely used observer rating, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between the ages of 18 and 60
  • Current DSM-V 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 PTSD, 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 β-HCG
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240003


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Franklin Schneier, MD NYSPI
Publications:

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Responsible Party: Franklin Schneier, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03240003    
Other Study ID Numbers: 7527 (SAD)
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Schneier, New York State Psychiatric Institute:
Social Anxiety
Social Anxiety Disorder
SAD
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders