Evaluation of a Visual Remediation Intervention for Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, visual processing, cognitive training, visual training
Eligibility Criteria
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.
Sites / Locations
- Rutgers University Behavioral Health Care (UBHC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
visual training condition
control condition
Arm Description
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.
Participants assigned to the control condition will receive standard Partial Hospital care without visual training.
Outcomes
Primary Outcome Measures
contrast sensitivity
A measure of low-contrast stimulus detection; contrast sensitivity thresholds at varying spatial frequencies will be examined.
contour integration
A measure of visual perceptual organization; total number correct, adjusted for guessing, will be examined.
Secondary Outcome Measures
Full Information
NCT ID
NCT03117452
First Posted
April 12, 2017
Last Updated
March 28, 2018
Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of California, Riverside, Nathan Kline Institute for Psychiatric Research
1. Study Identification
Unique Protocol Identification Number
NCT03117452
Brief Title
Evaluation of a Visual Remediation Intervention for Schizophrenia
Official Title
Evaluation of a Visual Remediation Intervention for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of California, Riverside, Nathan Kline Institute for Psychiatric Research
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, visual processing, cognitive training, visual training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
visual training condition
Arm Type
Experimental
Arm Description
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.
Arm Title
control condition
Arm Type
No Intervention
Arm Description
Participants assigned to the control condition will receive standard Partial Hospital care without visual training.
Intervention Type
Behavioral
Intervention Name(s)
Visual Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
contrast sensitivity
Description
A measure of low-contrast stimulus detection; contrast sensitivity thresholds at varying spatial frequencies will be examined.
Time Frame
approximately 14 weeks (baseline and post-treatment)
Title
contour integration
Description
A measure of visual perceptual organization; total number correct, adjusted for guessing, will be examined.
Time Frame
approximately 14 weeks (baseline and post-treatment)
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy L. Thompson, Ph.D.
Phone
732-235-9297
Email
judy.thompson@rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Steven M. Silverstein, Ph.D.
Phone
732-235-5149
Email
steven.silverstein@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy L. Thompson, Ph.D.
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University Behavioral Health Care (UBHC)
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy L. Thompson, Ph.D.
Phone
732-235-9297
Email
judy.thompson@rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of a Visual Remediation Intervention for Schizophrenia
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