SchizophreniaNCT03117452
Evaluation of a Visual Remediation Intervention for Schizophrenia
A study testing Visual Training in people with Schizophrenia, run by Rutgers, The State University of New Jersey at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Visual Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rutgers University Behavioral Health Care (UBHC)
Piscataway, New Jersey, 08854
Judy L. Thompson, Ph.D., 732-235-9297, judy.thompson@rutgers.edu
About this study
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
- Being tested
- Visual Training
- Keywords
- schizophrenia, visual processing, cognitive training, visual training
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual TrainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| visual training condition | Experimental | 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. Receives: Behavioral: Visual Training |
| control condition | No intervention | Participants assigned to the control condition will receive standard Partial Hospital care without visual training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
contrast sensitivity
A measure of low-contrast stimulus detection; contrast sensitivity thresholds at varying spatial frequencies will be examined.
Measured: approximately 14 weeks (baseline and post-treatment)
contour integration
A measure of visual perceptual organization; total number correct, adjusted for guessing, will be examined.
Measured: approximately 14 weeks (baseline and post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start23 Feb 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside, Nathan Kline Institute for Psychiatric Research
- Responsible party
- Principal investigator, Judy L. Thompson, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Judy L. Thompson, Ph.D., Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117452
- Sponsor's protocol ID
- Pro20160000350
- Other IDs
- PC 51-16
- Status last verified
- Mar 2018
- First submitted
- 12 Apr 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Visual Remediation Intervention for Schizophrenia
- ClinicalTrials.gov ID
- NCT03117452
- Acronym / sponsor ID
- Pro20160000350
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, visual processing, cognitive training, visual training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of California, Riverside, Nathan Kline Institute for Psychiatric Research
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| visual training condition | Experimental | Behavioral: Visual TrainingParticipants 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. |
| control condition | No intervention | –Participants assigned to the control condition will receive standard Partial Hospital care without visual training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual TrainingThe 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. | Behavioural | visual training condition |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy L. Thompson, Ph.D. principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Training in people with Schizophrenia, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy L. Thompson, Ph.D. (732-235-9297, judy.thompson@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contrast sensitivity (time frame: approximately 14 weeks (baseline and post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.