Evaluation of a Visual Remediation Intervention for Schizophrenia

Schizophrenia Clinical Trial

Official title:

Evaluation of a Visual Remediation Intervention for Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117452
• Other study ID #: Pro20160000350
• Secondary ID: PC 51-16
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2017
• Last updated: March 28, 2018
• Start date: February 23, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2018
• Source: Rutgers, The State University of New Jersey
• Contact: Judy L. Thompson, Ph.D.
• Phone: 732-235-9297
• Email: judy.thompson[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Rutgers University Behavioral Health Care (UBHC)	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Nathan Kline Institute for Psychiatric Research, University of California, Riverside

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contrast sensitivity	A measure of low-contrast stimulus detection; contrast sensitivity thresholds at varying spatial frequencies will be examined.	approximately 14 weeks (baseline and post-treatment)
Primary	contour integration	A measure of visual perceptual organization; total number correct, adjusted for guessing, will be examined.	approximately 14 weeks (baseline and post-treatment)