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Evaluation of a Visual Remediation Intervention for Schizophrenia

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ClinicalTrials.gov Identifier: NCT03117452
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
University of California, Riverside
Nathan Kline Institute for Psychiatric Research
Information provided by (Responsible Party):
Judy L. Thompson, Ph.D., Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date March 30, 2018
Actual Study Start Date  ICMJE February 23, 2017
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • contrast sensitivity [ Time Frame: approximately 14 weeks (baseline and post-treatment) ]
    A measure of low-contrast stimulus detection; contrast sensitivity thresholds at varying spatial frequencies will be examined.
  • contour integration [ Time Frame: approximately 14 weeks (baseline and post-treatment) ]
    A measure of visual perceptual organization; total number correct, adjusted for guessing, will be examined.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03117452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Visual Remediation Intervention for Schizophrenia
Official Title  ICMJE Evaluation of a Visual Remediation Intervention for Schizophrenia
Brief Summary Schizophrenia is a severe psychiatric condition that is associated with significant distress and disability. In addition to cognitive difficulties in domains such as attention, memory, and problem-solving, individuals with schizophrenia can experience visual-processing abnormalities, including impairments in visual acuity, low-contrast stimulus detection, and perceptual organization (i.e., perceiving visual information in an organized "perceptual whole"). These visual impairments are clinically significant, with research indicating that specific visual-processing alterations are significantly related to poorer performance on higher-level cognitive tasks, impaired facial emotion recognition, impaired reading ability, and worse functional outcomes. Despite such findings, very few studies have evaluated the therapeutic potential of interventions that are specifically designed to improve visual processing ("visual remediation") for individuals with schizophrenia. Thus the aim of this study is to evaluate the efficacy of a computerized visual perceptual training program that targets low- and mid-level visual processes to improve visual, cognitive, and emotion-recognition functions in outpatients with schizophrenia through a small randomized controlled trial. The investigators will recruit up to 40 individuals with schizophrenia or schizoaffective disorder who are receiving treatment in Rutgers University Behavioral Health Care (UBHC) Partial Hospital Program; half will be randomized to receive the computerized visual training, which will be delivered in small groups over a period of 12-14 weeks. The specific aims of this study are to collect preliminary data on: 1) the feasibility of participant recruitment and retention, and tolerability of the treatment components of the study; and 2) the efficacy of computerized visual training (VT) to improve low- and mid-level visual processes, and higher-level cognitive and social-cognitive performance. Based on preliminary data, the investigators hypothesize that the target number of participants will be successfully recruited and engaged in the VT intervention (n=16) and control condition (n=16), and that the participants who receive VT will demonstrate greater improvements on measures of low- and mid-level visual, higher-level cognitive, and social-cognitive functions compared to those who receive standard partial-hospital care without VT. The results of this initial trial will be used to inform the design and application for funding of a larger-scale investigation of visual remediation for individuals with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Half of the participants will be randomized to receive the computerized visual training, which will be delivered in small groups over a period of 12-14 weeks, and the other half will be assigned to the control condition, which consists of standard Partial Hospital care without visual training.
Masking: Single (Outcomes Assessor)
Masking Description:
All participants will be assessed on outcomes of interest by trained clinical interviewers who are blind to the treatment condition in which participants are assigned.
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Behavioral: Visual Training
The computerized visual training (VT) program that is being evaluated was developed by Aaron Seitz, who is a co-investigator on this project; it includes 1) ULTIMEYES, which targets broad-based visual functions, including low-level processes (e.g., visual acuity, contrast sensitivity), and 2) visual perceptual organization exercises, which target mid-level visual processes. Both elements of the program also involve higher-level visual functions, such as visual search and visual attention.
Study Arms  ICMJE
  • Experimental: visual training condition
    Participants in the visual training condition will participate in the visual training (VT) group, during which they will complete computerized visual training that targets low- and mid-level visual processes. Each group will include a maximum of 3 participants and will meet 3 times a week over a period of 12-14 weeks.
    Intervention: Behavioral: Visual Training
  • No Intervention: control condition
    Participants assigned to the control condition will receive standard Partial Hospital care without visual training.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2019
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between the ages of 18-60.
  • Meets DSM-5 criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder.
  • Currently attends the Rutgers UBHC Partial Hospital Program and plans to continue attending for at least the next 16 weeks.
  • If the participant is treated with antipsychotic medication, he/she is on stable treatment with this medication (i.e. no change in medication type, or substantial change in dose, for at least 4 weeks prior to participating in the study and no anticipated change for the next 16 weeks).
  • Has capacity to provide informed consent.
  • Is fluent in English.
  • Has a minimum binocular visual acuity of 20/100, as assessed at baseline using a standard eye chart, with the participant's typical vision correction (e.g., with glasses if the participant typically wears glasses).

Exclusion Criteria:

  • Has met DSM-5 criteria for a substance-use disorder within the last 12 months (with the exception of tobacco use disorder, which will be permitted).
  • Has a verbal IQ score of < 70 per the Wechsler Test of Adult Reading (WTAR).
  • Current or recent history of a medical condition that significantly affects the structure or function of the brain or eye (e.g., ocular or retinal disease, thyroid disease, untreated hypertension, uncontrolled diabetes).
  • Current or past neurological or neurodevelopmental disorder such as seizure disorder, cerebral palsy, intellectual disability, or pervasive developmental disorder.
  • Has a "lazy eye" or history of severe eye injury.
  • Has received electroconvulsive therapy within the last 8 weeks.
  • Has a history of head injury with loss of consciousness lasting more than 10 minutes or with neurobehavioral consequences of the injury (e.g., need for follow-up treatment, cognitive or behavioral changes following the injury, etc.).
  • Any current use (last month) of non-prescribed amphetamines, opiates, cocaine, sedative-hypnotics, and/or cannabis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Judy L. Thompson, Ph.D. 732-235-9297 judy.thompson@rutgers.edu
Contact: Steven M. Silverstein, Ph.D. 732-235-5149 steven.silverstein@rutgers.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03117452
Other Study ID Numbers  ICMJE Pro20160000350
PC 51-16 ( Other Grant/Funding Number: New Jersey Health Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Judy L. Thompson, Ph.D., Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE
  • University of California, Riverside
  • Nathan Kline Institute for Psychiatric Research
Investigators  ICMJE
Principal Investigator: Judy L. Thompson, Ph.D. Rutgers University
PRS Account Rutgers, The State University of New Jersey
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP