Evaluation of a Visual Remediation Intervention for Schizophrenia

NCT ID: NCT03117452

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2019-02-28

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.

Conditions

Schizophrenia

Keywords

schizophrenia; visual processing; cognitive training; visual training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Visual Training

Intervention Type: BEHAVIORAL

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.

control condition

Participants assigned to the control condition will receive standard Partial Hospital care without visual training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Riverside

OTHER

Sponsor Role: collaborator

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Judy L. Thompson, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy L. Thompson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Rutgers University Behavioral Health Care (UBHC)

Piscataway, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Judy L. Thompson, Ph.D.

Role: CONTACT

Phone: 732-235-9297

Email: judy.thompson@rutgers.edu

Steven M. Silverstein, Ph.D.

Role: CONTACT

Phone: 732-235-5149

Email: steven.silverstein@rutgers.edu

Facility Contacts

Judy L. Thompson, Ph.D.

Role: primary

Other Identifiers

PC 51-16

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro20160000350

Identifier Type: -

Identifier Source: org_study_id