Improving Accessibility and Personalization of Cognitive Remediation for Schizophrenia
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: New York State Psychiatric Institute

Study Title: Improving Accessibility and Personalization of Cognitive Remediation for 
Schizophrenia 
 
Clinicaltrials.gov: NCT03576976 
 
 
Study Protocol 
Date of Approval: 05/24/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Improving Accessibility and Personalization of Cognitive Remediation for Schizophrenia  
 
Protocol Information: 
 
IRB of Record: New York State Psychiatric Institute 
Protocol # 7638 
First Date of IRB Approval: 05/24/2018 
Contact Principal Investigator: Alice Medalia, PhD  
Co-Investigator(s): Scott Stroup, MD Alice Saperstein, PhD 
NYSPI PI Division: Behavioral Health Services and Policy Research 
 
Source of Funding: Federal  
Institute/Agency: National Institute of Mental Health  
Grant Name: Optimizing and Personalizing Interventions for Schizophrenia Across the Lifespan  
Grant Number: 1 P50 MH 115843 
 
Background, Significance and Rationale: Schizophrenia is associated with persistent 
neurocognitive deficits that do not respond to pharmacologic treatment and add to illness 
burden by imposing significant limitations on the ability to adhere to pharmacotherapy, benefit 
from psychosocial programs, and function in the social, vocational, and educational venues 
integral to community integration. Neurocognition is a crucial intervention target. Cognitive 
remediation (CR) is an evidence-based practice to treat the pervasive and significant cognitive 
deficits that contribute to functional decline in schizophrenia. New York State Office of Mental 
Health (NYS OMH) is the first and largest state system of care to implement a statewide 
program of cognitive remediation (CR), an evidence-based practice for improving cognition and 
aiding functional recovery. Through Cognitive Remediation to Promote Recovery (CR2PR), CR 
is offered in outpatient programs, with plans to expand to more services and further adapt 
implementation to improve treatment outcomes. This project will work directly with NYS OMH 
clinics that offer CR2PR to build upon and improve current methods of delivering cognitive 
remediation. 
 
Purpose: This project studies the impact of two adaptations. One adaptation focuses on 
increasing the accessibility of the program, which participants report is limited by the 
requirement of twice-weekly attendance. This project will compare the delivery of CR in either 
two clinic-based sessions (Clinic) or one clinic and one remote session (Hybrid) per week. The 
second adaptation is intended to improve personalization of CR by systematically accounting for 
individual differences in neurocognitive needs. Drawing upon convergent evidence for tailoring 
CR based on need for early auditory processing (EAP) training, this project integrates a 
measure of EAP into the  baseline assessment to facilitate personalization of the menu of 
restorative computer-based exercises used in CR. The primary purpose of data analyses is to 
inform the feasibility and acceptability of the adaptations. The primary outcome will be treatment 
satisfaction. The secondary outcomes will be change in neurocognition from pre- to post-
treatment. 
 
Study Locations: New York State Psychiatric Institute and NYS OMH Facilities: 
✓ Washington Heights Community Service 
✓ Creedmoor Psychiatric Center  
✓ Kingsboro Psychiatric Center  
✓ Manhattan Psychiatric Center  
✓ Rockland Psychiatric Center  
✓ South Beach Psychiatric Center 

Description of Subject Population: The study sample includes adults with schizophrenia or 
schizoaffective disorder who are referred to and eligible for CR2PR.   
 
Procedures: There are two phases of this study. 
 
Phase 1: Staff training and Start up (Months 1-3).  
The focus in this initial phase is staff training, using the same combination of web, telephonic 
and in person training currently in place for CR2PR. Clinic staff trained on cognitive assessment 
will be provided with and trained to administer the Tone Matching Test as an additional 
component of the baseline assessment administered for routine CR treatment planning. The 
CR2PR clinicians will be trained on hybrid delivery methods and to use the Tone Matching Test 
results to personalize the menu of cognitive exercises such that the treatment plan for only 
those identified as EAP impaired will include the EAP exercises that are available in the web-
based programs used by CR2PR clinics. CR2PR clinicians will be trained on the protocol for 
Hybrid CR delivery. 
 Phase 2: Pilot Feasibility Trial (Months 4-36).  
The focus of this phase is to implement and evaluate cognitive remediation.   
Recruitment Methods: Participants will be recruited from New York State Office of Mental 
Health (OMH) psychiatric facilities where cognitive remediation (CR) is currently a clinical 
service (Cognitive Remediation to Promote Recovery, i.e. CR2PR) under the supervision of PI 
Medalia. Research referrals will be tied to the current system of referrals for participation in each 
clinic’s CR program. Clinical staff will refer potential participants to the CR clinician who will 
explain the program and invite participation. If clients are interested in CR services, the CR2PR 
clinician will send all referrals to a research assistant who will explain research procedures, 
obtain informed consent, and screen for eligibility.  Patients who want CR but who do not want 
to participate in the study will continue with the standard CR service procedures. The research 
study will not be advertised. 
 
Informed Consent:  All clients who agree to an initial meeting with research assistant will 
have the full study explained to them, and will have ample opportunity to ask questions prior to 
signing consent. The process of informed consent will include explanation of the amount of time 
required, the possible risks/benefits of study participation, their right to refuse participation in the 
study without prejudice and alternatives to study participation, their right to terminate 
participation at any moment without prejudice, procedures to protect confidentiality, potential for 
de-identified data sharing, and the contact information for the PI and IRB.  
Eligibility: 
 
Inclusion Criteria  
 
 
Methods of Ascertainment 
1. Attending OMH Clinic  
 
Referral by clinic personnel to the clinic's CR2PR program 
 
2. Diagnosis of Schizophrenia or 
Medical chart review and/or report from referring clinician 
Schizoaffective disorder 
 
and treating psychiatrist 
 
3. Age 18-65   
 
 
Client report, collected by research assistant 
 
4. Full Scale IQ 70 or above 
Wechsler Test of Adult Reading, administered by research 
assistant 
5. English fluency 
Wechsler Test of Adult Reading and observation during 
consent 

5. Psychiatric and 
 
 
Columbia-Suicide Severity Rating Scale administered by 
Behavioral stability 
 
 
research assistant and clinical team observation 
 
Exclusion Criteria   
 
Methods of Ascertainment 
1. Unremitted substance  
 
Medical chart review and/or report from referring clinician  
dependence / dependence   
and treating psychiatrist 
in the past 6 months 
 
2. Neurological illness  
 
Client report; Medical chart review 
3. Traumatic brain injury in   
Client report; Medical chart review 
the last 2 years  
Procedures: A trained research assistant will obtain informed consent, screen for eligibility and 
obtain additional sociodemographic information. Participants will complete the standard CR2PR 
neurocognitive assessment battery plus the TMT with a trained clinician. Following completion 
of the baseline assessment, participants will be randomized using a pre-determined 
randomization sequence made by the research team to either Clinic or Hybrid CR.  
 
Clinic CR: This is the evidence-based CR intervention currently in use at the OMH clinics. The 
Clinic research arm consists of 30 sessions delivered at 2 times per week in a group format of 
up to 8 participants with rolling admission. Each session consists of 45 minutes of working on 3-
4 computerized exercises to improve specific cognitive skills. CR2PR clinicians are trained to 
select cognitive exercises from a menu of web-based programs to improve the cognitive 
functions identified as impaired on the assessment, e.g., attention, memory. With the addition of 
the TMT, they will be able to identify EAP as a focus area. Computer exercises are followed by 
15-minute manualized discussion groups which promote generalization of cognitive gains on 
computer activities to functional gain by encouraging participants to link within-session cognitive 
activities to daily activities and recovery goals. 
 
Hybrid CR: The Hybrid condition consists of 15 clinic sessions in the above format, and 
independent work on cognitive exercises for 60 minutes per week for 15 weeks using a laptop, 
PC or tablet available to them (at home, school, clinic, library). Independent work on designated 
web-based computer exercises can be done in multiple or in one sitting. Clients will keep logs of 
their activities and issues related to remote practice. During the in-clinic session, the clinician 
will review their remote activities, problem-solve any access or activity related issues, provide 
personalized bridging, encouragement and feedback, and review the exercises to be completed 
remotely before the next clinic-based session. Clinicians will also maintain logs of their 
experiences with remote sessions to document issues pertinent to feasibility and effectiveness. 
 
Throughout treatment in both conditions, CR clinicians document service utilization by tracking 
scheduled sessions, attendance, treatment dropout and completion. PI Medalia will continue to 
provide supervision of CR clinicians as a part of overseeing the CR2PR program. 
 
Within one week following treatment completion, clients will be assessed for treatment 
satisfaction and change in neurocognitive functioning by a research assistant. Treatment 
completion is defined as at least 20 of 30 clinic sessions for the Clinic condition and at least 10 
of 15 clinic sessions for the Hybrid condition. A research assistant will conduct a semi-structured 
debriefing interview with each participant in the Hybrid condition about their experience using 
remote technology. At Study months 15 and 30, a research assistant will conduct a semi-
structured debriefing interview with each CR2PR clinician about remote technology use and 
how the tone matching test informed the choice of cognitive exercises. 

Criteria for Early Discontinuation: Criteria for early discontinuation from the study will follow 
clinic-based guidelines. A person is discontinued from a service if they are no longer able to 
attend due to scheduling conflicts (e.g., work/school), hospitalization for medical or substance 
use treatment, inpatient psychiatric hospitalization, or discharged from the clinic. The CR2PR 
clinician will use clinical judgment as to the appropriateness of continued participation for each 
participant, taking into account evidence of clinical worsening, suicidality, or other issues that 
may arise during participation. Consultation with the PI will be sought through routine 
supervision prior to discontinuation. No additional criteria will be used for research purposes. 
 
Assessment Measures: Screening measures include the Wechsler Test of Adult Reading 
(WTAR-5) and Columbia Suicide Severity Rating Scale. The Tone Matching Test is included in 
the assessment battery to tailor the CR treatment plan. The primary outcome measure will be 
treatment satisfaction. The secondary outcome will be change in neurocognition from baseline 
to post-treatment (approximately 15 weeks). 
 
▪ 
The Wechsler Test of Adult Reading (WTAR-5) will be used to estimate premorbid 
intellectual functioning and determine eligibility (Full Scale IQ ≥ 70). This assessment 
takes 3-5 minutes.  
 
▪ 
The Columbia-Suicide Severity Rating Scale will be used to assess psychiatric 
stability. Should suicidal ideation or behavior be endorsed, imminent risk will be further 
evaluated by the assessor and appropriate, immediate action will be taken. This 
assessment takes 5-10 minutes.  
 
▪ 
The Tone Matching Test (TMT) consists of pairs of 100-ms tones that are either the 
same or differ in pitch between 2.5 and 50%, with a 500-ms inter-tone interval. The 
participant listens to each tone pair and indicates whether the tones were the same or 
different. A cut-off score of 70% correct classifies EAP as impaired or intact. This test 
takes approximately 7-10 minutes and will be administered by the designated clinician at 
each clinic at baseline.  
 
▪ 
Treatment Satisfaction: Following completion of CR, all clients are asked to complete a 
questionnaire rating satisfaction with the treatment experience, working alliance with the 
CR clinician, and perceived benefits from the intervention. Items are rated on a sale of 1 
to 6. The outcome measure is an average of all ratings with higher ratings indicating 
greater satisfaction.  This measure takes approximately 2 minutes to complete. 
Treatment satisfaction will be compared between groups.  
 
▪ 
Neurocognition: The Brief Assessment of Cognition in Schizophrenia (BACS) is a 
standardized battery. Selected subtests will assess verbal memory, working memory, 
speed of processing, and executive function. The tests will take approximately 25 
minutes to complete. It is routinely administered by a designated CR2PR clinician at 
each clinic before treatment. A trained research assistant will administer the battery at 
post-treatment. The Continuous Performance Test – Identical Pairs (CPT-IP) is a 
computerized test that assesses attention/vigilance. Participants view numbers flashed 
on a computer screen and are to respond when the same number appears twice in a 
row. The test takes 14 minutes to complete. It is routinely administered by the 
designated CR2PR clinician at each clinic before treatment. A trained research assistant 
will administer the test at post-treatment. The outcome measure is an average T score 
from all neurocognitive subtest T scores. Change in neurocognition will be compared 
between groups. 

Research Related Delay to Treatment: Research procedures will not result in a delay to 
treatment. All clients will have access to the Cognitive Remediation program provided routinely 
at their clinic. 
 
Clinical Treatment Alternatives: All clients who decline to participate in research will continue 
the usual process of intake into their clinic’s CR program. They may receive cognitive 
remediation as usual. 
 
Risks/Discomforts/Inconveniences: The main risk is loss of confidentiality. In addition, 
patients may become mildly uncomfortable or tired during assessments or during cognitive 
training. However, no adverse reactions to the assessments or interventions have been 
reported during the two years the clinical service has been in place at the clinics or in 
preliminary studies. The software used in this study is the same or similar to that used in clinical 
practice in New York state OMH clinics with high levels of satisfaction. Although there are no 
anticipated risks as a function of the assessments or intervention, given that the sample 
involves people with psychotic disorders, it is conceivable that participants may feel burdened 
by procedures, or may experience psychiatric symptom exacerbation unrelated to the study. 
 
Methods to Minimize Risk:  
 
Confidentiality: The primary risk is loss of confidentiality. Procedures associated with potential 
loss of confidentiality, and measures to protect confidentiality are listed in the consent form. A 
HIPAA Authorization form, reviewed at the time of informed consent, lists those entities with 
whom knowledge of participation and data may be shared. Confidentiality will be preserved by 
coding all hard copy data sheets, session logs, and electronic files using a unique numerical 
identifier not linked to personal identifying information (e.g. name, date of birth). Consent forms 
will contain identifying information but will not be coupled with numerical identification numbers. 
Study computers used for collecting and storing data will be encrypted. Hard copy data will be 
maintained in a locked file cabinet and electronic files will be stored on password protected, 
encrypted computers, in a locked office at NYSPI. Only the research team will have access to 
electronic data. Public dissemination of the results of this research will contain no identifying 
information about individual subjects. Data deposited into appropriate repositories for public 
sharing will be stripped of any personal identifying information to protect confidentiality. 
 
Burden or Fatigue: During assessments, breaks and refreshments may be provided to 
minimize burden or fatigue and, if feasible, assessment sessions may be divided. OMH 
clinicians have been trained to attend to signs of burden or fatigue during assessments and 
intervention. Participants will discuss their treatment experience with the CR clinician on a 
weekly basis. This will assist clinicians in trouble-shooting challenges (clinical or practical) to 
participation and minimize perceived burden. In-clinic, breaks during treatment sessions are and 
will continue to be offered as needed. Patients completing remote sessions may self-pace their 
completion of exercises and may do them in a location that is convenient and comfortable.  
 
Unanticipated Adverse Events: A trained research assistant will administer the Columbia-
Suicide Severity Rating Scale during the screening appointment to assess psychiatric stability. 
Should suicidal ideation or behavior be endorsed, imminent risk will be further evaluated by the 
assessor and appropriate, immediate action will be taken, similar to what is outlined for clinical 
worsening. PI Medalia will coordinate with CI Saperstein to ensure that all research personnel 
are trained in safety procedures. Supervision of cognitive remediation clinicians with PI Medalia 
includes monitoring of patients’ clinical stability and ability to continue with treatment sessions. 
Clinical worsening will be reported to PI Medalia by research and clinical personnel and will be 

handled as per clinic safety procedures. Clinical worsening is defined as an increase in 
symptoms (e.g., hallucinations, paranoia) that causes significant distress, poses imminent risk, 
and/or impairs the ability of the individual to participate in study procedures. The consent form 
states that if the participant experiences an increase in symptoms or distress, the study 
personnel should be informed and will assist the participant in getting the help they need. When 
research personnel encounter clinical worsening during any study-related procedure they will 1) 
assist the subject in contacting their primary case worker, therapist, or psychiatrist and 2) report 
the urgent clinical issue to PI Medalia. In the unlikely situation that a subject is deemed to be an 
imminent risk to self or others (i.e., expresses imminent suicidal or homicidal ideation), the study 
personnel will physically walk the subject to their primary case worker, therapist, or psychiatrist. 
Further course of action may include contacting security to escort the participant to the 
emergency room or to call 911. Any unanticipated adverse event will be reported immediately to 
PI Medalia by the cognitive remediation clinician or research personnel. 
 
Certificate of Confidentiality: This study will be conducted under a Certificate of 
Confidentiality. 
 
Direct Benefits to Subjects: Cognitive remediation and computerized learning software have 
been used in many psychiatric patient populations in various settings and are well-recognized 
procedures without serious risk. There is potential for direct benefit to the patient participants, 
such as improvement in cognition, and potential benefits for the treatment of other people with 
neuropsychiatric disorder. 
 
Compensation or Reimbursement: Participants will be compensated $40 for the baseline 
assessment and $60 for the post-treatment assessment. 
 
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