Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: VA Office of Research and Development

 
Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia 
NCT01992913  
May 14, 2017 

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CMCVAMC SPECIFIC PROTOCOL SUMMARY 
Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC) 
Institutional Review Board (IRB) 
 
A. Protocol Title 
1. 
Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia 
(Short Name: BEST Vet – Building Employment Skills through Therapy for Veterans) 
 
2. 
Date of Protocol Summary and Version #: Date 05/04/2017; Version # 17 
 
B. Principal Investigator’s Full Name and Degree: Steven Sayers, Ph.D. 
 
C. Co-Investigator’s Full Name and Degree:  Paul Grant, Ph.D. 
 
D. Financial Sponsor (Provide the name of the agency, organization, company or person providing 
funds for the research study.)  VA Rehabilitation R&D  
 
E. Grant (Provide the name of individual who holds the grant and the grant number, if applicable.) 
Steven L. Sayers, Ph.D., grant number D1157-R 
 
F. Protocol Number (Provide the financial sponsor’s protocol number, if applicable.)  D1157-R   
 
G. Institution(s) responsible for the project: 
1. 
For single-site studies - CMCVAMC is the only institution involved.  Yes 
  No 
 
2. 
For multi-center studies. 
2.1. 
CMCVAMC is the Coordinating Center in which the PI is the lead investigator.  Yes 
  
No 
  N/A 
   
2.2. 
Provide the name of the Coordinating Center.  Yes 
  No 
  N/A 
 
2.3. 
List the name of the other sites involved.   Not Applicable. 
2.4. 
Provide the FWA numbers for each of the other sites involved.  Not Applicable. 
 
THE FOLLOWING INFORMATION MUST BE CMCVAMC-SPECIFIC, THAT IS, SPECIFIC TO WHAT 
WILL BE DONE WITH CMCVAMC-RECRUITED VETERANS. 
 
H. Background and Significance (Describe succinctly and clearly the past findings which justify the 
plan for this project.  A summary of the relevant literature in the area of interest and reports of 
previous studies should be included.):   1Between two and three million American adults 
currently suffer from schizophrenia.2 The modal onset occurs in early adulthood, and roughly 
two-thirds of affected individuals experience a chronic or fluctuating course of illness.3 This 
latter group is amongst the most expensive receiving psychiatric services, with the overall 
direct treatment costs and indirect costs incurred due to unemployment and lost productivity 
approaching $63 billion in the United States.1 Although antipsychotic medications have been 
readily available for more than half a century, the impact of these agents on functional 
outcomes has been modest, even when medication regimes have been optimized.4 By 
contrast, psychiatric rehabilitation programs have been shown to improve psychosocial 
functioning.5 Vocational rehabilitation services, in particular supported employment (SE), 
have the best evidence base. As compared to those patients not participating in such 
services, patients successfully engaged in SE are more likely to be working competitive jobs, 
working full time, earning higher wages, and reporting a higher quality of life.6 Furthermore, 
steady employment has been shown to generate significant savings in the use of mental 
health services use compared to patients who are minimally employed.7 Given the impressive 
benefits of SE programs, it is disappointing that so few eligible patients agree to participate in 
them. Patients who do not engage in treatment achieve the poorest outcomes,8 have the 
lowest quality of life, and are at risk for symptom exacerbation, recurring hospitalization, 
persistent homelessness, violence toward others, and suicide.9 Indeed, “providing appealing 

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and effective treatment to those who could derive benefit but who choose to avoid treatment 
remains an ongoing challenge”9 in schizophrenia. 
 
Our group has responded to this challenge by developing a new integrated Cognitive 
Behavior Therapy (iCBT) protocol designed for low functioning patients with schizophrenia 
who are not participating in psychiatric rehabilitation services such as SE. It is pragmatic, 
multimodal, recovery-oriented, and extends to some of the most challenging patients (e.g., 
those with the predominant negative symptoms and/or low insight). Our recent article in the 
Archives of General Psychiatry demonstrates that this approach is efficacious at improving 
functional outcomes and increasing motivation relative to standard treatment when delivered 
by PhD therapists in a university setting.10 The current proposal aims to compare usual care 
to iCBT to see if there are differences in their ability to improve work outcomes achieved by 
VA patients with schizophrenia enrolled in SE. Not being enrolled in SE or being enrolled but 
not active both produce little benefit. The goal of adding iCBT or usual care is to increase the 
patients’ motivation to achieve their own recovery goals and direct their own engagement in 
constructive activity such as utilization of SE.  
 
I. Purpose of the Project (Clearly provide the purpose of this research project.): The objective of the 
current proposal is to improve work outcomes and functional outcomes of veterans with 
functional disability who are not participating in psychiatric rehabilitation services that are 
available to them. 
 
J. Describe the Research Questions or Hypotheses (that is, what questions are you trying to 
address by conducting the research.): The objective of the current proposal is to evaluate 
whether iCBT vs. treatment as usual can improve engagement and success in an existing SE 
program among the most functionally disabled patients with schizophrenia.  
 
K. Primary Outcome Variable(s) (Define the primary outcome variable(s) used to support the study 
objectives (e.g. if the objective is to show that treatment A is superior to treatment B in the treatment 
of subjects with essential hypertension, the primary outcome variable is blood pressure 
measurement.): Our primary specific aim is to determine whether iCBT will significantly 
improve work outcomes at post-treatment to a greater extent than usual care in low 
functioning patients with schizophrenia who are enrolled in SE. The primary outcome 
measures are several work-related indices of work participation across the 18 months of 
active study involvement, including the following: 1) instances of job attainment, 2) average 
days worked per week while employed, 3) average number of hours worked per week while 
employed, 3) total weeks worked , and 4) a composite of these indices.  
 
L. Secondary Outcome Variable(s) (Define the secondary outcome variables. Such measured 
variables should also include the timing of measurement.): The second trial outcome measures 
will include the Work behavior Inventory (WBI) and the Specific Levels of Functioning Scale 
(SLOF). A significant ITT difference on the WBI and the total SLOF score across 6 and 12 
months would support the hypothesis that ICBT is more efficacious than usual care at 
improving functioning by the end of treatment (Secondary Aim 1). Similarly, WBI score and 
the SLOF total score at 18 months is a secondary outcome, and the separate ITT effects on 
functioning at 18 months with the respective month-treatment interaction in favor of iCBT 
would support the hypothesis that it promotes better functioning than usual care during the 6 
months after the completion of treatment (Secondary Aim 3).  
 
M. Study Design and Methods: 
1. 
Is this a clinical trial?       
YES     
NO  (Randomized non-drug/non-medical device 
intervention) 
1.1. 
If yes, what type?  Check all that apply.  
  Phase I      
  Phase II          
  Phase III      
  Phase IV 
1.2. 
If yes, this study must be registered on Clinicaltrials.gov. 

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2. 
Design 
2.1. 
What research methods will be used in the project?  Check all that apply. 
 Surveys/Questionnaires 
 Interviews           
 Audio Taping 
 Behavioral Observations 
 Chart Reviews    
 Video Taping 
 Focus Groups 
 Randomization 
 Double-Blind 
 Control Group 
 Placebo 
 Withhold/Delay Treatment 
 Specimen Collection 
 Deception 
 Telephone Survey 
 Other (Describe) 
 
 
2.2. 
Describe how randomization or other treatment assignment will be made.  
Randomization will occur on a 1:1 basis to one of the two study conditions (iCBT 
or usual care) using a permuted block randomization with randomly varying 
block sizes of 2, 4 and 6 and stratification by gender (because females with 
schizophrenia have a better course and may respond better to traditional CBT). 
The study biostatistician will generate randomization lists based on the above 
procedure. The encrypted randomization file will be located on a server (i.e.,  
\\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to Improve 
Work) that is not accessible to the study personnel who make subject contact 
during the randomization procedure. S/He will access the file and provide the 
randomization token.  S/He will not have subject contact nor know which 
condition is being assigned. Further, s/he does not have a stake in the outcome 
of the study. 
2.3. 
For retrospective research studies, provide the “look-back” period.  (e.g., December 1, 
1999 through December 31, 2008.) Not Applicable. 
 
3. 
Study Duration 
3.1. 
Provide the estimated length of time to enroll all subjects and complete the study. To 
allow that not all identified patients will qualify and not all qualifying patients will 
elect to participate, we will conduct more baseline screenings than required. We 
propose, accordingly, to consent to the baseline assessment 48 patients in the 
first year of the study (months 6 to 12), 96 patients in the second year (months 13 
to 24), and 48 patients in the third year (months 25 to 30), producing 24 
randomized patients in year 1, 48 in year 2, and 24 in year 3, for an estimated total 
of 96 randomized subjects (48 per group). All 96 subjects will be randomized by 
middle of the third year.  Data collection will be complete after the middle of the 
fourth year.  
3.2. 
Explain the expected duration of subject participation including any follow-up. iCBT will 
be delivered as a group  therapy for 12 months of weekly or biweekly sessions 
(see below). Usual care (and iCBT) will entail continued access to all treatments 
available to all Veterans receiving treatment at the CMC VAMC Mental Health 
Clinical without restriction. Blind, reliable independent assessors, who are part of 
the study team, will reassess participants every 6 months after participants begin 
treatment over an 18-month participation period, producing mid-treatment (6 
month) end-of-treatment (12 month), and post-treatment (18 month) assessments.   
3.3. 
Specify the projected date of completion of the proposed study. We plan to complete 
the study at the end of fiscal year 2018.  
 
4. 
Drug Information (If not applicable state, “Not Applicable.”) Not Applicable. 
4.1. 
Specify if the drug or biological agent is:   
4.1.1. 
FDA approved       
4.1.2. 
Used for off-label purposes       
4.1.3. 
Not yet FDA approved.       
4.2. 
Include the FDA Investigational New Drug (IND) number for all non-FDA approved and 
off-label drugs, biological agents or nutritional supplements.  If not applicable state, “Not 
Applicable.”       
4.3. 
Provide all relevant information about the drug       

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4.4. 
Explain any wash-out periods, rescue medications permitted and any type of 
medications not permitted while enrolled in the study.        
4.5. 
Describe blinding and un-blinding procedures.        
4.6. 
Include the dosage, route of administration, previous use, and the safety and efficacy 
information on any drug used for research purposes.       
4.7. 
Describe rationale for the dosage in this study.        
4.8. 
Justify why the risks are reasonable in relation to anticipated benefits and/or knowledge. 
      
4.9. 
Describe where drug preparation will be done.       
4.10. All drugs for CMCVAMC subjects must be dispensed through the VA investigational 
pharmacy.       
4.11. Describe where the study treatment will be administered.       
4.12. Describe plan for tracking a non-compliant treatment study subject.       
4.13. Summarize any pre-clinical data.       
4.14. Describe the process for the storage, security, dispensing and return of an 
investigational drug.       
 
5. 
Investigational Device (If not applicable state, “Not Applicable.”) Not Applicable. 
5.1. 
The Investigational Device Exemption (IDE) number must be submitted for all significant 
risk devices and if an IDE exists for a non-significant device.       
5.2. 
Significant Risk or Non-significant Risk - If a device is not approved by the FDA, specify 
whether or not the sponsor has determined this device to be a “significant risk” or “non-
significant risk” as defined by the FDA.       
5.3. 
Provide all relevant information about the device.       
5.4. 
Describe blinding and un-blinding procedures.        
5.5. 
Specify if device is:   
5.5.1. 
FDA approved       
5.5.2. 
Used for off-label purposes       
5.5.3. 
Not yet FDA approved.       
5.6. 
Explain if the investigational device will be delivered and/or stored by the Principal 
Investigator or Pharmacy Services.        
5.7. 
Describe the process for the storage, security, dispensing and return of an 
investigational device.       
5.8. 
For research involving an investigational device, describe the SOP or plan for device 
control.       
5.9. 
Address how the device will be stored in such a way that only research staff associated 
with the protocol will have access to the device.       
5.10. Describe measures that will be put into place to ensure that the device will only be used 
in participants of this research protocol.       
 
N. Does this project involve international research?   
YES 
NO    
1. 
For further instructions refer to VHA Directive 2005-050, Requirements for Conducting VA-
Approved International Research Involving Human Subjects, Human Biological Specimens, or 
Human Data 
2. 
VHA Handbook 1200.05 definition of international research - VA international research is any 
VA-approved research conducted at international sites (not within the United States (U.S.), its 
territories, or Commonwealths); any VA-approved research using either human biological 
specimens (identified, de-identified, or coded) or human data (identified, de-identified, or 
coded) originating from international sites; or any VA-approved research sending such 
specimens or data out of the U.S. (see par. 56). NOTE: For the purposes of this Handbook, 
research conducted at U.S. military bases, ships, or embassies is not considered international 
research.  
 
O. Study Procedure 
1. 
Study Procedures 

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1.1. 
Outline all study procedures - (If necessary, include a table or flow chart, showing the 
schedule of the procedures and interactions.  Distinguish between interventions that are 
experimental and carried out for research purposes vs. those that are considered 
standard of care. Routine procedures that are performed solely for research purposes 
should also be identified.)   
 
Consenting patients will be administered a baseline assessment battery 
(diagnostic, work outcomes, functional outcomes, symptom, neurocognitive, and 
attitude measures) to determine eligibility. Baseline assessment procedures will 
take approximately 4-5 hours. (Please see section O.2.1 for full descriptions of 
the assessment battery.) Subjects will be notified of their eligibility status for the 
treatment component of the research by phone within 2 weeks of their baseline 
assessment.  
 
The research team will seek permission to obtain the contact information of a 
secondary contact person, to assist in maintaining contact with the veteran over 
the course of the 18 active months of the study. Though participants will be 
encouraged to provide this information, they may refuse to do so and still remain 
in the study. The research team will not disclose any information to this 
secondary contact person.  
 
Eligible subjects who give a second informed consent will be randomly assigned 
to receive either iCBT or to usual care. All randomized participants will enter into 
supportive employment at the CMCVAMC. iCBT will be delivered as a group  
therapy for 12 months of weekly or biweekly sessions (see below). iCBT sessions 
will take approximately 1 hour. Blind, reliable independent assessors will 
reassess participants every 6 months after  participants begin treatment groups 
over an 18-month participation period, producing mid-treatment (6 month) end-of-
treatment (12 month), and post-treatment (18 month) assessments. Follow-up 
assessment procedures will take approximately 3-4 hours. The Research 
Coordinator will conduct a 15-minute Check-In at baseline to gather information 
about medications and services being received outside of this research study; 
the Supported Employment Specialists or Independent Assessors will conduct 
the 15-minute Check-In every 3 months after participants begin treatment groups 
(i.e., at 3-, 6-, 9-, 12-, 15-, and 18-months). The SE Specialists will also conduct the 
assessment of employment variables at these Check-Ins using the Workforce 
Participation form using an informal interview assisted by the use of a calendar 
and review of holidays and other activity anchors, supplemented by the ongoing 
assessment they conduct as part of the SE activities.  
 
We are proposing a prospective randomized controlled trial with participants 
recruited from the CMCVAMC.  We will randomize 96 patients (48 patients per 
condition). Independent assessors will be blinded to participant treatment group 
allocation. Assessment sessions will occur at baseline, and at 6, 12, and 18 
months after therapy groups begin; brief check-ins will occur at each assessment 
session, and also at months 3, 9, and 15 after therapy groups begin.   
 
Subjects in the iCBT condition will receive weekly or twice weekly group sessions 
for 12 months. iCBT follows a treatment manual developed by Perivoliotis, Grant, 
& Beck. The manual details the approach (engagement, behavioral activation, 
cognitive remediation/restructuring, maintenance) and individualized treatment 
planning. It also describes strategies and techniques to deal with positive and 
negative symptoms, mood symptoms, and suicidality. Included in these 
strategies are mindfulness exercises, designed to assist the participant in 
identifying feelings and biological processes that accompany a stimulus (i.e., 

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food and/or drink).  It incorporates cognitive remediation strategies. iCBT 
sessions will be video recorded, for purposes of quality control and supervision. 
 
Subjects in both conditions will participate in the existing SE program at 
CMCVAMC.  
 
All participants will continue to receive any services (medical, psychiatric, case 
management) they were already receiving.  
 
The primary outcome measure will be the work participation indices, including 1) 
instances of job attainment, 2) average days worked per week while employed, 3) 
average number of hours worked per week while employed, 3) total weeks 
worked, and 4) a composite of these indices Secondary outcomes measures will 
be total score of the Work Behavior Inventory (WBI) at the 6, 12, and 18 month 
follow up and the total score on the Specific Levels of Functioning scale (SLOF) 
measured at post-treatment 6, 12, and 18month follow-up. 
 
Treatment conditions 
Usual Care - Usual care will entail continued access to all treatments available to 
all Veterans receiving treatment at the CMC VAMC Mental Health Clinical without 
restriction. 
 
iCBT - Subjects in the iCBT condition will receive sessions of group therapy 
scheduled at least once every week for up to 12 months following randomization. 
iCBT will follow a treatment manual developed by Perivoliotis, Grant, & Beck74 
based upon conceptualizations developed in Schizophrenia: Cognitive Theory, 
Research, and Therapy.21 The manual details the modular approach (engagement, 
behavioral activation, maintenance) and individualized treatment planning. It also 
explains in detail strategies and techniques for negative symptoms, 
hallucinations, delusions, anxiety, depression, and suicidality. It also gives 
guidelines for when and how to incorporate the UCLA social skills role-plays37 
and cognitive remediation strategies.75 The employment specialists will be 
masters level clinicians and will provide the iCBT. iCBT sessions will be video 
recorded, for purposes of quality control and supervision. 
 
i. 
Cognitive remediation - Cognitive remediation refers to programs that target 
specific cognitive domains and aim to improve them, often through 
thousands of repetitions of the same task, an approach called “drill and 
practice.”38 There is substantial evidence that cognitive remediation 
significantly improves performance on cognitive batteries in people with 
schizophrenia39, and (perhaps by extension) improves measures of 
functioning. Several recent meta-analyses of cognitive remediation programs 
have found moderate effect sizes for improvement in cognitive functioning40, 
social cognitive functioning,41 and psychosocial functioning.40  Kurtz 
conducted a literature review of studies that reported neurocognitive data in 
the context of different psychosocial interventions. He concluded that global 
cognition, and attention, memory, and problem-solving domains, were 
associated with outcome variables in people with schizophrenia enrolled in 
vocational rehabilitation programs.42.  Five randomized control trials have 
been conducted integrating cognitive remediation and vocational 
rehabilitation. McGurk et al. reviewed 4 of the 5 trials in a 2008 review article, 
and subsequently published the results of another trial. In her review, and in 
the 2009 trial, she concluded that the combination of cognitive remediation 
and vocational rehabilitation improved both cognitive functioning and 
vocational rehabilitation outcomes.43, 44 

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The cognitive remediation program we will use, Brain HQ by Posit Science 
(https://portal.brainhq.com/?study=best_vet), is a series of computer 
“games” developed by neuroscientists to target particular areas of cognition, 
for instance verbal and visuo-spatial memory, working memory, sustained 
attention, set-shifting, planning and problem solving, and others. The 
program is designed to provide practice on these cognitive areas in the form 
of interactive and engaging computer games. Brain HQ software is 
commercially available and targeted at a healthy adult population looking to 
improve cognitive skills that are already within the normal range of 
performance. It has also been developed for clinical populations with a 
unique training set for people with schizophrenia, and it has programs with 
more gradual increases in challenge level, less emphasis on timed tests, and 
a new interface for facilitators working with patients.  
 
The cognitive remediation module lasts 4 months. During this module, 
participants will meet twice weekly for hour-long sessions. 40 minutes of 
those sessions will be devoted to computerized cognitive remediation using 
Brain HQ. The cognitive domains practiced by the subjects will be 
individually tailored to the areas of greatest cognitive weakness of each 
subject. During the cognitive reappraisal portion (see below), the challenges 
and gains of the subjects using Brain HQ will be discussed and the 
relationship of the skills mastered to employment situations will be 
discussed.  The employment specialists will perform the cognitive 
remediation. Consistent with cognitive remediation programs already in place 
at CMCVAMC, the Brain HQ patient kiosk is connected to the local network, 
and provides access to the Internet; patients will be monitored by the 
Supported Employment Specialist during computer use. The name, email 
address, and password requested when logging on this site will be that of the 
Supported Employment Specialist (SES), who will then enter a subject code 
for each subject.  Thus no identifiable information about the subject is being 
entered for use of this computer program. 
 
ii. 
Cognitive reappraisal skills.  During the cognitive remediation and cognitive 
reappraisal module, participants will meet twice weekly. The cognitive 
reappraisal portion will occur 10 minutes prior and 10 minutes after cognitive 
remediation. The difficulties and gains encountered during cognitive 
remediation will be discussed. In particular, cognitive restructuring will be 
conducted around expectancies and attitudes that might block goal 
achievement. This will involve training patients to recognize negative 
automatic thoughts (“I can’t do it,” “I do not have the energy), to identify 
thinking errors (e.g., emotion based reasoning such as “if it feels like I can’t 
do it, then I can’t do it”), and to generate alternative explanations to specific 
unhelpful or inaccurate thoughts and beliefs. All skills are taught in a fun and 
engaging manner. 
 
March 2016 Amendment 
This protocol was initially submitted with a study objective to evaluate whether 
iCBT vs. Psychoeducation (PE) can improve engagement and success in an 
existing SE program among the most functionally disabled patients with 
schizophrenia. 
 
We decided to change the control group from Psychoeducation (PE) to usual 
care.  We made this change because experts in randomized clinical trials (RCT) 
design have recently argued that control condition that is “active” in an effort to 

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equalize the attention association with the experimental intervention can reduce 
the power of the design to detect that impact of the intervention.87 Thus, a control 
condition that is also active may lead to biasing the study against detecting a 
difference compared to the experimental group.  Psychoeducation is often used 
as a minimally active control condition in lieu of usual care. Unfortunately, 
psychoeducation has been demonstrated to reduce relapse, reduce and shorten 
hospital admissions, and improve medication compliance76. It is an active 
comparator to iCBT, given its significant improvements in areas related to 
functional outcome. Again, this may in fact reduce the ability to detect a positive 
impact of iCBT.  
 
This study change was approved by the Sponsor (See Request for Administrative 
Modification of a Rehabilitation Research and Development Service (RR&D) 
Project form signed by Patricia Dorn, Director, RR&D) 
 
Plans for subjects already enrolled in the study:  Prior to this change in the 
control arm, we were in the initial stages of existing participants who have been 
randomized and remain active (3 iCBT group, 3 Psychoeducation group). Since 
the Psychoeducation participants expect a group, will offer all these participants 
the iCBT group. Because those two participants who had been randomized to the 
Psychoeducation group would be offered the iCBT outside the original design, 
their data will be excluded from data analysis. They will otherwise receive all the 
benefits of the study.  
 
All existing consented and randomized participants will be re-consented 
describing the new design just specified, with a usual care arm (that does not 
involve any group treatment). Again, those participants who want to participate in 
a group treatment (or an additional group if they are in iCBT arm), have the 
treatment resources of the Mental Health Clinic that they can access outside of 
their involvement in this study. 
 
Supported Employment (SE). SE is the standard clinical intervention that is 
offered to Veterans with severe mental illness. Therefore, SE is not a research 
intervention. However, the supported employment specialists will be a part of the 
research team. Subjects randomized to either treatment group (i.e., iCBT, usual 
care) will participate in SE. All participants will also continue receive psychiatric 
care. Case management will continue for subjects already receiving such 
services. The SE program will adhere to the IPS model adopted by the CMCVAMC 
in 2005 as part of a national initiative (see Background, above). The IPS model has 
been well described 18 and training occurs through a mentor-trainer model. 
Multiple studies have demonstrated the importance of high fidelity scores on SE 
program evaluation in terms of employment outcomes77. 
1.2. 
Explain if and how the follow-up of subjects will occur. The baseline assessment is 
designed to: a) determine baseline levels of work functioning, psychosocial 
functioning, symptomatology, cognitive impairment, and dysfunctional belief 
endorsement, and b) determine whether participants are eligible for the treatment 
phase of the study. 
 
The research team will strive to form treatment groups as quickly as possible. 
However, it may take several weeks to accumulate enough eligible and willing 
participants to form a treatment group (i.e., 6-8 participants). The intention of the 
follow-up assessments and check-ins is to measure the impact of treatment on 
the study measures. Therefore, the follow-ups and check-ins are tied to the 
beginning of the treatment groups.  
 

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All participants who are eligible and consent to randomization will participate in 
three additional assessment sessions. The mid-treatment and post-treatment 
assessments are designed to measure change from baseline that occurred 
during the treatment period and will consist of a re-administration of the baseline 
measures. The follow-up assessment occurs 6 months after the end of the 
treatment period (18 months after treatment groups begin). The Research 
Coordinator will conduct the 15-minute check-in at baseline; the Supported 
Employment Specialists or Independent Assessors will conduct the check-in 
every 3 months after treatment groups begin (i.e., at 3-, 6-, 9-, 12-, 15-, and 18-
months). 
1.3. 
Describe where, how and who will be conducting study procedures.  The primary 
purpose of the follow-up assessments is to determine the durability of change 
post-treatment.  Table 1 depicts the study assessment timetable. Baseline study 
assessments will be carried out by the study Research Coordinator, while follow-
up assessments will be carried out by the Independent Assessors. The Research 
Coordinator will conduct the 15-minute check-in at baseline; the Supported 
Employment Specialists or Independent Assessors will conduct the check-in 
every 3 months after treatment groups begin (i.e., at 3-, 6-, 9-, 12-, 15-, and 18-
months). 
                  Table 1: Assessment measures and administration timeline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.4. 
If a survey study, specify the estimated amount of time that subjects will need to 
complete the questionnaires/tools.  The baseline assessment will take approximately 
4-5 hours. The follow-up assessments will take approximately 3-4 hours. The 
check-ins will take approximately 15 minutes. 
1.5. 
If a blood draw, specify the amount of blood to be drawn in milliliters and in teaspoonfuls 
or tablespoonfuls and specify how often and where the blood will be drawn. Not 
Applicable. 
 
Measure 
Baseline 
3 Month 
(after 
groups 
begin) 
6 Month 
(after 
groups 
begin; mid 
treatment) 
9 Month 
(after 
groups 
begin) 
12 Month 
(after 
groups 
begin; end 
of groups) 
15 Month 
(after 
groups 
begin; 
post 
groups) 
18 Month 
(after 
groups 
begin; 
post group 
follow up) 
SCID 
X 
 
- 
 
- 
 
- 
WHODAS 
X 
 
- 
 
- 
 
- 
Work 
Readiness 
X 
 
 
 
 
 
 
Risk 
Assessment 
X 
 
 
 
 
 
 
Data from 
WBI 
X 
 
X 
 
X 
 
X 
SLOF 
X 
 
X 
 
X 
 
X 
BNSS 
X 
 
X 
 
X 
 
X 
SAPS 
X 
 
X 
 
X 
 
X 
DAS 
X 
 
X 
 
X 
 
X 
ABS 
X 
 
X 
 
X 
 
X 
BSES-SF 
X 
 
X 
 
X 
 
X 
QOLI 
X 
 
X 
 
X 
 
X 
BCIS 
X 
 
X 
 
X 
 
X 
CNB 
X 
 
X 
 
X 
 
X 
B-CATS 
X 
 
X 
 
X 
 
X 
UPSA 
X 
 
X 
 
X 
 
X 
Check-in 
X 
X 
X 
X 
X 
X 
X 
Workforce 
Participation 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Note. “X” = measure administered 

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2. 
Data Collection (Include all questionnaires and survey tools with the submission.) 
2.1. 
Provide 
2.1.1. 
the mode of data collection, e.g. telephone, in-person, questionnaire, 
interviews: Interview tools include: The Structured Interview for DSM-IV-
TR Axis I Disorders, Clinical Trials Version (SCID); World Health 
Organization Disability Assessment Scale v. 2.0 (WHODAS),Work 
Behavior Inventory (WBI),Specific Level of Functioning Scale (SLOF), 
Brief Negative Symptom Scale (BNSS), Scale for the Assessment of 
Positive Symptoms (SAPS), the Check-In, and the Work Readiness 
Assessment The 15-minute check-in is a tool developed by the research 
team to capture information about medications and services being 
received outside of the study, and will include measures of workforce 
participation. Training of assessors on the clinical interview will follow 
the UCLA model of initial training, competency (ICC ¬> .80 with a 
minimum of 10 cases), and prevention of rater drift (sessions every 6 
months). 
 
Questionnaires include: Dysfunctional Attitude Scale (DAS),63 Asocial 
Beliefs Scale (ABS),64 Beck Self-Esteem Scales – Short Form (BSES-
SF),65 the Quality of Life Inventory (QOLI),66 and the Beck Cognitive 
Insight Scale (BCIS).67  
 
Cognitive and Functional Tests include: the Computerized 
Neurocognitive Battery (CNB), the Brief Cognitive Assessment Tool for 
Schizophrenia (B-CATS), and the USCD Performance-Based Skills 
Assessment – Brief (UPSA-B). 
 
Specific Levels of Functioning Scale (SLOF).56 The SLOF is a self-report 
behavioral rating scale used to assess mentally ill patients’ level of 
functioning in the community and in mental hospitals. The 30-item scale 
emphasizes subjects’ everyday behaviors rather than emotional or 
mental capacity, and it focuses on subjects’ tangible strengths and skills 
rather than on subjects’ weaknesses. Subjects rate their typicality of 
certain behaviors and self-sufficiency regarding basic tasks on a 5-point 
scale, in the areas of interpersonal relationships, social acceptability, 
activities, and work skills. A high total suggests a higher level of 
functioning in the subject, while a low total suggests relatively lower 
functioning. The SLOF is considered to be one of the best scales for 
measuring functional outcomes in terms of reliability, convergent 
validity, sensitivity, and practicality.60  
 
World Health Organization Disability Assessment Schedule 2.0 
(WHODAS).56 The WHODAS is an interviewer-administered assessment 
designed to determine the level of functioning in subjects with 
schizophrenia. The WHODAS measures a number of areas, including 
cognition, mobility, self-care, sociability, life activities, work/school 
activities, and participation. Each item is measured on a 5-point scale, 
with higher totals indicating higher levels of dysfunction. Schennach-
Wolff et al.61 found the WHODAS to have predictive validity for early 
response, response, remission, and symptomatic outcome. 
 
Brief Negative Symptom Scale (BNSS).57  The BNSS is a 13-item 
interviewer-scored instrument for assessing the negative symptoms of 
schizophrenia. Each item is rated on a 7-point scale: “Normal/No 
Impairment” (0), “Questionable/Very Slight Impairment” (1), “Mild/Mild 

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Deficit” (2), “Moderate/Moderate Deficit” (3), “Moderately 
Severe/Moderately Severe Deficit” (4), “Severe/Marked Deficit” (5), 
“Extremely Severe/Severe Deficit” (6). The items are organized into six 
subscales: Anhedonia (3 items), Distress (1 item), Asociality (2 items), 
Avolition (2 items), Blunted Affect (3 items), and Alogia (2 items). The 
total score is the sum of the 13 items, with the total possible score 
ranging from 0 to 78. Higher scores are indicative of greater negative 
symptomatology.  
 
Scale for the Assessment of Positive Symptoms (SAPS).58  The SAPS is a 
34-item interviewer-scored instrument for assessing the positive 
symptoms of schizophrenia. Each item is scored on a 6-point scale 
(“Absent” (0), “Questionable” (1), “Mild” (2), “Moderate” (3), “Marked” (4), 
“Severe” (5)). There are four subscales: Hallucinations (6 items), 
Delusions (12 items), Bizarre Behavior (4 items), and Positive Formal 
Thought Disorder (8 items). In a manner similar to the SANS, each SAPS 
subscale is also assigned a global rating. Participants’ positive symptom 
levels will be indexed by the global SAPS score, which is the sum of the 
four subscale global ratings. The range of the SANS global score is 0 to 
20, with higher scores indicative of greater negative symptomatology. 
Additionally, the global score of the SAPS Psychotic factor is defined as 
the sum of the Hallucinations and Delusions subscale global scores, 
while the global score for the SAPS Disorganized factor is defined as the 
sum of the Bizarre Behavior and Positive Formal Thought Disorder global 
scores. Andreasen and colleagues have shown that the SAPS can be 
reliably administered with people diagnosed with schizophrenia, and a 
recent consensus statement has proposed the SAPS as a standard 
measure of positive symptoms.62  
 
Check-In. The check-in is a tool developed by the research team to 
capture information about medications and services being received 
outside of the research study. There are six main sections: (1) mood, (2) 
medications, (3) current treatment, (4) hospitalizations, (5) legal issues, 
and (6) demographics.  The Check-In will include measures of workforce 
participation (as described below). 
 
Workforce Participation. This report form is also completed during the 
check-in and reflects the timing of job attainment, average days worked 
per week while employed, average number of hours worked per week 
while employed, and total weeks worked, These indices reflect common 
and accepted variables that reflect the degree of success in obtaining 
competitive employment and at a competitive compensation rate. 
 
The Work Readiness Assessment. The Work Readiness Assessment was 
developed by David Loveland at the Human Service Center in Peoria, IL, 
and is based on the Transtheoretical Model of Change and the principles 
of motivational interviewing 
(http://www.bhrm.org/guidelines/motiveint.pdf). It is comprised of two 
scales: the Understanding of Benefits scale and the Work Motivation 
scale. Participants are asked to rate items on a 3-point scale (i.e., 
“disagree,” “not sure,” “agree”) regarding their understanding of 
benefits, and a 4-point scale (i.e., “disagree,” “somewhat agree,” “mostly 
agree,” “strongly agree”) regarding their motivation to work. Assessors 
will use this data to determine a participant’s overall work readiness on 
the following scale: Pre-contemplation about working, Contemplation for 

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working, Determination/preparation for working, Active stage of job 
seeking, and Maintaining job seeking activities or working. 
 
Risk Assessment. The Risk Assessment is a tool developed by the study 
team to evaluate the potential risks (to the participant and study staff) in 
enrolling the participant into phase 2 of the research study. The risk 
assessment will be completed as part of the baseline/screening 
assessment, and then as clinically indicated throughout study 
participation (e.g., when a subject moves, after an inpatient 
hospitalization, etc.). 
 
Questionnaires. Belief endorsement and quality of life, questionnaires 
include: Dysfunctional Attitude Scale (DAS),63 Asocial Beliefs Scale 
(ABS) ,64 Beck Self-Esteem Scales – Short Form (BSES-SF),65 the Quality 
of Life Inventory (QOLI),66 and the Beck Cognitive Insight Scale (BCIS).67  
 
Dysfunctional Attitude Scale (DAS).63 The DAS consists of 40 statements 
rated on a 7-point scale: “Agree Totally” (7), “Agree Very Much” (6), 
“Agree Somewhat” (5), “Neutral” (4), “Disagree Somewhat” (3), “Disagree 
Very Much” (2), and “Disagree Totally” (1). Participants are instructed to 
select the option that describes how they think most of the time. Sample 
items include: “If I do not do as well as other people, it means I am an 
inferior human being”; “If I fail at my work, then I am a failure as a 
person”; “If I fail partly, it is as bad as being a complete failure”; “If you 
cannot do something well, there is little point in doing it at all”; “Making 
mistakes is fine because I can learn from them (reverse keyed).” The DAS 
is composed of two subscales: Defeatist Performance Attitudes and 
Dysfunctional Need-for-Acceptance attitudes. The DAS can be reliably 
administered and its utility in outpatient samples diagnosed with 
schizophrenia has been established.22 
 
Asocial Beliefs Scale (ABS).64 The ABS is composed of 15 items self-
reported as “True” or “False” (scored “1” or “0”) that tap attitudes and 
preferences related to spending time with other people. Sample items 
include: “I prefer watching television to going out with other people,” 
“people sometimes think I am shy when I really just want to be left 
alone,” and “I could be happy living all alone in a cabin in the woods or 
mountains.” In both patient and control populations, the ABS has been 
shown to be internally consistent and have high test-retest reliability.68 
Grant and Beck have shown that these items, which are a subscale of the 
larger Revised Social Anhedonia Scale (RSAS), predict current and future 
social functioning.31 
 
Beck Self-Esteem Scales – Short Form.65  Beck Self-Esteem Scales – 
Short Version. 65 The BSES-SF is a 12-item questionnaire that assesses 
beliefs about the self and others’ impressions of the self. Domains 
queried include superior/inferior, likeable/unlikeable, strong/weak, 
secure/vulnerable, efficient/helpless, and powerful/powerless. Responses 
are made to each bipolar set of adjectives on a 10-point scale (anchors 
are “very much”, “average”, and “very much”). Modifications to the 
original form include: (1) the measure was shortened to capture the 
essence of self-esteem, and (2) seven of the twelve adjectives have been 
modified to better suit this population based on clinical experience. 
 

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Quality of Life Inventory (QOLI).66  The QOLI consists of 32 self-reported 
items that tap subjective functioning. Participants are presented with 
descriptions of 16 life domains: health, self-esteem, goals-and-values, 
money, work, play, learning, creativity, helping, love, friends, children, 
relatives, home, neighborhood, and community. For each domain, the 
subject makes an importance judgment on a 3-point scale -- “Not 
Important” (0), “Important” (1), “Very Important” (2) -- and a satisfaction 
judgment on a 6-point scale  -- “Very Dissatisfied” (-3),  “Dissatisfied” (-
2), “Somewhat Dissatisfied” (-1), “Somewhat Satisfied” (1), “Satisfied” 
(2), “Very Satisfied” (3). QOLI scores for each domain are determined by 
multiplying the importance rating by the satisfaction rating. The total 
QOLI score is the sum of the 16 individual domain scores; higher scores 
reflect higher reported quality of life. 
 
Beck Cognitive Insight Scale (BCIS).67 The BCIS is a 15-item measure of 
two components (factors) of cognitive insight—the capacity and 
willingness to observe one’s experiences and consider alternative 
explanations (self-reflectiveness) and the overconfidence in the validity 
of one’s beliefs (self-certainty). Sample items include, “There is often 
more than one possible explanation for why people act the way they do” 
and “My interpretations of my experiences are definitely right.” In the 
original study with inpatients of varying diagnoses, the BCIS showed 
adequate convergent and discriminant validity and internal consistency 
(α = .60-.68). The original psychometrics and factor structure have now 
been replicated several times.69 Taken together, the research on the BCIS 
suggest that cognitive insight has important clinical significance for 
people with schizophrenia, that it may be a mediating variable in 
cognitive therapy for the disorder, and that it should therefore be 
assessed and addressed in clinical trials.69 
 
Collection of information from the Work Behavior Inventory (WBI).55 The 
WBI is a 35-item scale specifically designed to assess the work behaviors 
of individuals suffering from severe mental illness. The WBI is completed 
as a routine standard of care measure during Supported Employment 
procedures. As part of usual care, the SE Specialists observes the 
patient in his/her work setting and also speak to the subject’s supervisor 
(when the veteran allows this).  As part of the research study, we will 
collect information from the WBI at the time of the baseline and follow-up 
assessments. The measure will have a value of ‘0’ at points in which the 
participants are not working.  WBI data may be missing if research 
participants refuse to allow the SE specialist to observe at the worksite 
and/or speak to employers. Data from the WBI will be analyzed along with 
other research data whenever available. The WBI is broken down into 
specific areas, including social skills, cooperativeness, work habits, work 
quality, and personal presentation. Each item is scored on a 5-point 
scale, with higher totals indicating stronger work performance. The WBI 
has been found to have good validity and reliability55 and predicts 
vocational outcomes and productive activity after discharge from 
rehabilitation. 
 
Performance measures 
a) Cognitive  
The Computerized Neurocognitive Battery (CNB). The CNB, developed by 
Ruben Gur and colleagues, is widely used and validated.70 The version we will 
use evaluates both accuracy and speed of performance in the following 5 

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domains: abstraction and mental flexibility (Penn Conditional Exclusion Test), 
attention and working memory (Letter-n-Back), spatial memory (Visual Object 
Learning Test [VOLT]), spatial processing (Computerized Judgment of Line 
Orientation), and sensorimotor dexterity (Computerized Finger-Tapping Task 
and Motor Praxis test). Participants will be given standard instructions and 
practice trials with feedback to assure comprehension. Collected data are 
uploaded automatically to the VA MIRECC secure server using PGP encryption 
and reviewed for validity. Accuracy and response time for each trial are 
recorded and the domain scores for accuracy and speed are available in a 
relational database. The scoring code has been validated against manually 
scored tests. This procedure is fully automated. 
 
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS).71: The B-CATS 
is a 10-12 minute measure of global cognitive function designed for clinicians 
to administer and interpret. The B-CATS is composed of 3 neurocognitive 
tests, Trail Making Test (parts A and B), animal fluency, and Digit Symbol.  
 
b) Functional capacity 
The UCSD Performance-Based Skills Assessment-Brief (UPSA).72 :The UPSA 
assesses functional capacity -- that is, the expected ability of subjects to 
function in a variety of real-world settings. This measure assesses skills in two 
areas: a) Communication (making phone calls, making emergency calls, 
rescheduling a medical appointment, and others), and b) Finance (e.g. 
counting change, writing checks, and paying bills). The brief UPSA (10 -15 min) 
has been shown to correlate at 0.91 with the scores on the full UPSA.73 
2.1.2. 
the precise plan for how data is to be collected or acquired At the baseline 
assessment interview, a member of the research team (PI, Co-I, or 
research coordinator) will administer a comprehensive, face-to-face 
interview that allows for a reliable diagnosis of schizophrenia and 
queries patient psychosocial functioning levels, symptomatology, 
substance use, and service usage.  At other assessments, the 
independent assessors will perform semi-structured interviews, collect 
questionnaire data, and administer cognitive and performance tests.  
2.1.3. 
exact location where data will be collected, In a pre-arranged 2nd floor 
MIRECC interview room (B228). 
2.1.4. 
exact location where data entry will take place. In the pre-arranged 2nd floor 
MIRECC interview room (B228) and the research coordinator’s and 
independent assessors’ cubicles in the 2nd floor MIRECC (B228). 
2.1.5. 
the “title” of individual(s) collecting the data and analyzing the data, e.g. 
principal investigator, research coordinator. Principal Investigator, Co-
Investigators, Research Coordinator, Independent Assessors. 
2.2. 
Provide a time line for each aspect of the study. Assessment sessions will occur at 
baseline, and at 6, 12, and 18 months after treatment groups begin.  Check-ins 
will occur at baseline, and then every 3 months after treatment groups begin. 
 
Subjects in the iCBT condition will receive weekly or twice weekly group 
sessions for 12 months. It incorporates cognitive remediation strategies, and a 
specific computerized cognitive remediation 4-month block (see below). Subjects 
assigned to usual care will continue to receive usual care for 12 months. Subjects 
in both conditions will participate in the existing SE program at CMCVAMC. All 
participants will continue to receive any services (medical, psychiatric, case 
management) they were already receiving. The primary outcome measure will be 
the indices of workforce participation (jobs attained, hours per week, average 
days worked while employed, weeks employed, total income for the reporting 
period) . Secondary outcomes measures will be the total score on the Work 

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Behavior Inventory (WBI) and the total score on the Specific Levels of 
Functioning inventory (SLOF) measured at 6 months, 12 months, and 18 month 
post-treatment follow-up. 
2.3. 
Chart/Records/Data Review (retrospective and/or prospective) 
2.3.1. 
Provide the planned or approximate number of charts/records/data to be 
accessed 
2.3.1.1. CMCVAMC Phase I – 192; Phase II – 96  
2.3.1.2. Other site       
2.3.2. 
Does this protocol employ an Honest Broker?  
YES  
NO 
2.3.2.1. If yes, provide name of individual.  
2.3.2.2. If no, explain who will access the charts/records. Research 
coordinator, PI, Co-I. 
2.3.2.3. Describe from what database charts/records/data will be accessed.  
CPRS 
 
3. 
Future Use of Data and Re-Contact, if applicable.  Not Applicable 
3.1. 
If any of the participant’s data are going to be retained after the study for future 
research, the following information must be provided to the participant: 
3.1.1. Where will the data be stored?  
3.1.2. Who will have access to the data?  
3.2. 
If the subject is going to be re-contacted in the future about participating in future 
research, this must be specified.  Describe the circumstances under which the 
participant would be re-contacted whether within the VA or outside the VA. Not 
Applicable 
3.2.1. 
If subjects will receive aggregate study results at the end of the study, the 
informed consent document must contain this information. 
 
4. 
Specimen Collection 
4.1. 
Give the source of all specimens and whether they were collected for research, 
treatment or diagnosis. Not Applicable. 
4.2. 
State where specimens will be stored, secured and when discarded.  Not Applicable. 
4.3. 
Explain how destruction of samples will be substantiated.  Not Applicable. 
 
P. Genetic Testing, if applicable 
1. 
Explain if the study is looking for an association between a genetic marker and a specific 
disease or condition, but at this point it is not clear if the genetic marker has predictive value. 
Not Applicable.  
1.1. 
The uncertainty regarding the predictive value of the genetic marker is such that studies 
in this category will not involve participant counseling. 
1.2. 
Describe if the study is based on the premise that a link between a genetic marker and 
a specific disease or condition is such that the marker is clinically useful in predicting 
the development of that specific disease or condition.        
1.3. 
Will the subject be notified of the results and the provision for genetic counseling?  
 Yes   
 No  
 N/A 
1.3.1. 
If yes, explain further.        
1.4. 
If biological specimens are used in this protocol, please respond to the following 
questions by checking the appropriate box:  
 
YES NO N/A 
a. Does the project involve genetic testing? 
 
 
   
b. Will specimens be kept for future, unspecified use? 
 
 
 
c. Will samples be made anonymous to maintain confidentiality?  
(Instructions: Note:  If there is a link, it is not anonymous.  Coding 
is not anonymous. 
 
 
 
d. Will specimens be destroyed after the project-specific use is 
completed? 
 
 
 

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e. Will specimens be sold in the future? 
 
 
 
f. 
Will subjects be paid for their specimens now or in the future? 
 
 
 
g. Will subjects be informed of the results of the specimen 
testing? 
 
 
 
h. Are there any implications for family members based on 
specimen testing results? (If yes, they may be participants.) 
 
 
 
i. 
Will subjects be informed of results obtained from their DNA? 
 
 
 
1.5. 
Will specimens be de-identified?  
YES        
NO 
 N/A 
1.5.1. 
If yes, please describe the procedures to be used.        
1.5.2. 
Include at what point in the process the specimens will be de-identified.        
1.6. 
Describe what measures will be taken to minimize the following risks from breaches of 
confidentiality and privacy resulting from participating in THIS aspect of the research 
project:   
1.6.1. 
physical       
1.6.2. 
psychological       
1.6.3. 
financial       
1.6.4. 
social        
1.6.5. 
legal harm       
 
Q. Banking of Collected Specimens 
1. 
Will collected specimens be banked?  
YES   
NO   
N/A 
1.1. 
IF BANKING SPECIMENS, IT MUST BE AT AN APPROVED VA REPOSITORY. (For 
additional information, refer to VHA Handbook 1200.12, Use of Data and Data 
Repositories in VHA Research - March 9, 2009.) 
1.2. 
If yes, specify the location where specimens will be banked.        
1.3. 
Explain how destruction of banked samples will be substantiated.       
 
R. Subject Recruitment (characteristics of the study population) 
1. 
Provide the planned or targeted enrollment at: 
1.1. 
CMCVAMC -    Phase I:  192;  Phase II:  96  
1.2. 
Other sites -  0 
1.3. 
Not applicable; chart review or use of previously collected data - 
 
 
2. 
Screening and/or Eligibility Requirements  
2.1. 
Describe and provide justification for:  
2.1.1. 
Inclusion criteria  
The study inclusion criteria are as follows:  
i. 
Diagnosis of DSM-IV schizophrenia or schizoaffective disorder 
(SCID)  
ii. 
Severe/extreme functional disability [World Heath Organization 
Disability Assessment Scale (WHODAS) score > 50] 
iii. 
Clinical stability (as per primary mental health provider) 
iv. 
Receiving treatment at the Veterans Administration 
v. 
Minimal engagement in psychiatric rehabilitation services (just 
psychiatrist and therapist/case management in the last 6 
months) 
vi. 
Eligible and willing to be enrolled in Supported Employment 
program 
vii. 
Age 18 to 65 
viii. 
Proficient in English 
ix. 
Able to give informed consent  
2.1.2. 
Exclusion criteria  
i. 
Neurologic disease or damage that would make the diagnosis of 
schizophrenia questionable 
ii. 
Current opioid or stimulant dependence (SCID). 

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                       iii. 
Not appropriate due to safety concerns (based on risk  
 
assessment)  
 
2.2. 
List all screening and/or eligibility requirements. The Study Research Coordinator will 
gather the appropriate records relevant to inclusion. The study team will recruit 
research participants from the Compensated Work Therapy (CWT) program, the 
outpatient psychiatric clinic, and the inpatient psychiatric unit at the CMCVAMC. 
At the time of baseline assessment, subjects will be told that the study staff will 
query the subject’s psychiatrist regarding symptoms, psychosocial functioning, 
and medications.  
2.3. 
Explain any special test or evaluations potential subjects may have to undergo before 
they are actually determined to be eligible for the study. Based upon all available 
information (records and the clinical interview), a best-estimate diagnosis will be 
determined on consensus basis by the PI and Co-Investigator (Dr. Grant). The PI 
will then determine if eligibility criteria are met. 
2.4. 
Not Applicable; subjects not recruited; chart review.  
 
 
3. 
If applicable, indicate what populations will be targeted for recruitment as participants. 
Check all that apply.   
Males 
 
Females 
 
Inpatients 
 
Outpatients 
 
VA Employees 
 
Non-English Speaking** 
 
Veteran Family members*** 
 
Non-Veterans*** 
 
Other (Specify) 
 
Not Applicable, chart review 
 
3.1. 
**For non-English speaking subjects - If an investigator proposes to use a participant 
population that does not speak or read English, a copy of the translated document, as 
well as the English version, needs to be forwarded to the IRB for approval.  Translator 
certification is also required. Not Applicable. 
3.2. 
***If non-veterans will be recruited for this study, explain why sufficient veterans are not 
available to participate in the project [VHA Handbook 1200.5, paragraph 16a]. Veteran’s 
spouses/partners, caregivers, etc. are considered non-veterans for the purposes of this 
study.   Not Applicable.    
3.3. 
***Has approval to recruit non-veterans been received from the ACOS/R&D and 
Medical Center Director?   
3.3.1. 
 Not Applicable 
3.3.2. 
 Pending (Non-veteran forms should be used. IRB office will obtain 
approval from ACOS/R&D and Medical Center Director.) 
 
4. 
Does this project target a specific race or ethnic group as participants?  
YES  
 NO    
If yes, check all that apply. 
 Race 
 
 
Ethnicity 
 
American Indian or Alaskan Native 
 
 
Hispanic or Latino 
 
Asian 
 
 
Not Hispanic or Latino 
 
Black or African American 
 
 
Other 
 
Native Hawaiian or other Pacific 
Islander 
 
 
 
 
Black, not of Hispanic origin 
 
 
 
 
White, not of Hispanic origin 
 
 
 
 
Other 
 
 
 
 

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4.1. 
Provide justification why this/these group(s) was/were chosen. 
 
5. 
What is the age range of participants?  Check all that apply. 
Children (Under 18) Requires Waiver from CRADO (VHA 
Directive 2001-028, Research Involving Children) 
 
Young Adults (18-21) 
 
Adults (22-65) 
 
Seniors (Over 65) 
 
Over 89 
 
Not Applicable, chart review 
 
 
6. 
Are there specific reasons why certain populations (i.e., age, gender or ethnic groups) 
are excluded as participants?   
YES   
NO    
N/A 
6.1. 
If yes, specify reasons. Because of the supported employment (difficult to find 
competitive employment after age 65) and cognitive remediation (possible 
confound of age-related declines in older populations) portions of the protocol, 
veterans over the age of 65 are excluded.  
 
7. 
Does the project require enrollment of the following classes of participants? 
 
YES 
NO 
a. Employees 
 
 
b. Individuals with impaired decision making capability 
 
 
c. Pregnant women 
 
 
d. Economically and/or educationally disadvantaged persons 
 
 
e. Prisoners 
 
 
f. Illiterate, limited, or no English language proficiency 
 
 
g. Terminally ill patients 
 
 
7.1. 
If applicable, what is the justification for including any of the above classes of 
participants in the project?  Not Applicable. 
7.2. 
If the project requires enrolling any of the above classes of participants describe any 
project-specific measures or special considerations, steps, or safeguards to ensure that 
these individuals are adequately protected.  Not Applicable. 
 
8. 
Describe the exact plan how subjects will be identified and recruited for the study.   
8.1. 
Discuss methods, e.g., referrals from physician offices, clinics, programs, or through 
advertisements and brochures. Potential participants will be identified through the 
outpatient mental health clinic, the inpatient psychiatric unit, and the 
Compensated Work Therapy (CWT) program at the CMCVAMC. Identification of 
potential research participants will be two-fold: (1) the research team will conduct 
a review of the caseloads of the treating psychiatrists in the CMCVAMC 
outpatient mental health clinic and the inpatient psychiatric unit via CPRS review 
under a Waiver of Individual Authorization for Disclosure of Protected Health 
Information. The research team will communicate securely (e.g., via CPRS, 
encrypted email, secure server) regarding patients who may be eligible for the 
research study, and confer on the appropriateness of research participation; (2) 
treating psychiatrists in the outpatient mental health clinic and inpatient 
psychiatric unit will identify potentially eligible participants based on interest in 
SE and interest in learning about research. In either case, treating psychiatrists at 
the outpatient mental health clinic will refer individuals with SMI as per 
CMCVAMC standard protocol to the CWT program.  (This referral would be made 
regardless of eligibility in the research study.) Providers who refer potentially 
appropriate Veterans will ask them if they would consider participating in the 
research study. The study team will remind the clinician that they should 
document this referral in the patient’s chart.  Those who agree will be approached 
by the research staff (the PI, RC, independent assessors, and/or the SE 

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specialists) after they are referred to the CWT program through a CPRS consult 
created specifically for study referrals (i.e., SE Research Consult – Vocational 
Rehab Outpt). The consult note will remind providers that they can only refer 
patients who want to hear more about the study. The study team will receive an 
alert in the CPRS system once a study consult has been placed. The study team 
will regularly check for consults in the CPRS system. All consults will be received 
and resolved by the study team within 24 business hours, per CMCVAMC 
standard of care. Providers and the research team may also collaborate to 
identify potentially eligible participants with whom the provider has not yet 
discussed SE or study participation to receive a “recruitment opt-in letter” 
describing study participation and requesting that Veterans contact their treating 
providers and/or the study team to learn more about the study. Study referrals 
will follow guidelines outlined above and below if the Veteran reaches out to their 
provider and/or the research team to learn more about participation. 
 
If meeting in person, Research staff will provide the potential participant with 
information about the study (e.g., the research flyer, informational letter) and be 
given the option to consider participation in research. Research staff will also call 
potential subjects who have expressed interest in hearing more about the 
research study (See phone script).  Individuals who are interested in participating 
in the research will be invited to participate in the baseline assessment portion of 
the research study to determine eligibility for the treatment phase of the study. 
Potential participants may speak directly with a research team member or contact 
the research team via the telephone number listed on the recruitment materials 
(e.g., research flyer, informational letter).  Potential subjects who we cannot reach 
by phone and who the research team are unable to meet with during visits to the 
VA, will be mailed an informational letter (See Recruitment letter). 
 
Amendment August 15, 2016: The research team has interacted with a number of 
Veterans who disagree with their psychiatric diagnosis, or feel uncomfortable 
labeling themselves as someone with a diagnosis of 
schizophrenia/schizoaffective disorder, however still very much meet study 
inclusion criteria and otherwise express desire to participate in the study. To be 
sensitive to this issue, we have modified our consent documents – Veterans will 
be given the option of disagreeing with their psychiatric diagnosis while agreeing 
to study participation during the informed consent process. 
 
Mental Health Providers will learn about this research study through direct 
contact with research staff (i.e., PI, RC, SES), research flyers/brochures, and also 
through the CMCVAMC Mental Health services informational materials (e.g., the 
MIRECC’s Research Opportunities – Mental Health Provider Informational Sheet - 
a document distributed to CMCVAMC mental health providers, advertising 
CMCVAMC research studies, the Resource Center desktop icon). 
 
Research consult note is based on the current Supported Employment consult 
note and will include the following information. The consult is for Veterans who 
are interested in Supported Employment services, and who are also open to 
hearing about the research study. Veterans who decline participation in the 
research study components, but who are still interested in Supported 
Employment, will be referred to the CWT Supported Employment Program 
Manager for follow-up.:  
Current PC Provider:    
Current PC Team:        
Current Pat. Status:    
Primary Eligibility:    

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Patient Type:           
OEF/OIF:               
 
Service Connection/Rated Disabilities 
SC Percent:             
Rated Disabilities:     
 
Order Information 
To Service:            SE RESEARCH CONSULT - VOCATIONAL REHAB OUTPT 
From Service:           
Requesting Provider:    
Service is to be rendered on an OUTPATIENT basis 
Place:                 Consultant's choice 
Urgency:               Routine 
Earliest Appr. Date:    
Orderable Item:        SEE RESEARCH CONSULT - VOCATIONAL REHAB 
OUTPT 
Consult:               Consult Request 
Provisional Diagnosis: (Schizophrenia/Schizoaffective Disorder) 
Reason For Request: 
ERA: 
Service Connected:  
 
COMBAT SERVICE  - Yes/No 
_______________________________ 
Service Connected Condition?  
 
Is the reason for this consult because of a Service Connected condition:  
(Yes/No) 
************************************************************************* 
All patients must have a diagnosis of schizophrenia or schizoaffective disorder.  
(Schizophrenia or Schizoaffective Disorder) 
 
Reason for Request:  
(e.g., Patient is interested in finding employment. Patient is also interested in 
hearing about research study). 
   
Inter-facility Information 
This is not an inter-facility consult request. 
 
Status:                 
Last Action:            
8.2. 
If using a clinic, be specific about who will identify the potential subject and how that 
information will be transmitted to the research staff. The PI, RC, independent 
assessors, and/or the SE specialists will meet with all mental health clinicians in 
the outpatient clinic, the inpatient psychiatric unit, and the CWT program to 
discuss the study with providers. They will give them recruitment materials (e.g., 
flyers) to hand out to patients they feel might be interested in this study. 
8.3. 
If snowball method will be used, discuss the process and how the first individuals will be 
recruited. Providers can then give their patients a copy of the IRB-approved flyer.  
8.4. 
Describe how information will be disseminated to subjects, e.g. handouts, brochures, 
flyers and advertisements (include all recruitment materials with this submission). 
Providers can give their patients a copy of the IRB-approved flyer.   
8.5. 
Non-Veteran participants will be given a copy of the Notice of Privacy Practices. 
 

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9. 
Informed Consent 
9.1. 
Informed Consent will not be sought. 
 
9.2. 
Written informed consent from participants. 
 
9.3. 
Written informed consent from participants’ legally authorized representative (LAR) as 
required by VA policy and/or applicable state laws. 
 
9.4. 
Request Waiver of Documentation of Informed Consent 
 
9.5. 
List the title of the key personnel involved in the following activities: 
9.5.1. 
Person Obtaining Consent 
9.5.1.1. 
Provide the title(s) of individual(s) Principal Investigator, Co-
Investigator, Research Coordinator, Supported Employment 
Specialists, Independent Assessors 
9.5.1.2. 
Type of training received to perform this process: All Staff: 
HIPAA, GCP, and Human Subjects Protection Training. The 
research coordinator will attend the Research Coordinator 
training class offered by the Research Compliance Officer 
prior to engaging in research activities.  
9.5.2. 
Pre-Recruitment Screening (the use of medical records and other data 
bases to determine populations and individuals eligible for the study), Not 
Applicable 
9.5.3. 
Recruitment Process (the process in which individuals are contacted and 
first introduced to the study and to the possibility of participating as subjects), 
Principal Investigator, Co-Investigators, Research Coordinator, 
Supported Employment Specialists, Independent Assessors 
9.5.4. 
Informed Consent Process (the process by which recruited subjects are 
fully informed about participating in the study and then formally give their 
voluntary consent for participating), Principal Investigator, Co-Investigator, 
Research Coordinator, Supported Employment Specialists, Independent 
Assessors 
9.5.5. 
Screening of Recruited Subjects (those activities in the protocol in which a 
final determination of eligibility of prospective subjects is made during the 
early phases of the study, using laboratory data, inclusion and exclusion 
criteria, and other person-specific information), Principal Investigator, Co-
Investigator, Research Coordinator 
9.5.6. 
Include the breakdown of each individual’s responsibilities: 
9.5.6.1. 
Principal Investigator, Oversee the entire study design, 
implementation, and data collection. He will also provide 
clinical and diagnostic guidance.  
9.5.6.2. 
Co-Investigator, Dr. Grant will provide all the CBT trainings 
and monitor for fidelity and reliability. He will oversee 
training on structured interviews, questionnaires and 
oversee reliability. He will provide clinical and diagnostic 
guidance. Our TBD biostatistician will analyze all the data. 
S/he will also maintain the randomization key. 
9.5.6.3. 
Research Coordinator, The Research Coordinator (RC) will 
perform the baseline clinical interviews and assessments to 
determine eligibility for the treatment portion of this study. 
She will perform quality assurance checks on all research 
data; therefore she will not be blinded to treatment condition. 
The RC will obtain informed consent for all assessment 
procedures and will write the Research Consent Note. She 
will scan the informed Consent Documents and HIPAA 
Authorization forms into CPRS. She will call subjects to 
remind them of research assessment visits.  
9.5.6.4. 
Additional research staff by title: Supported employment 
specialists/therapists (SES) will assist in recruitment, may 

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obtain informed consent, conduct integrated cognitive 
behavioral therapy and cognitive remediation sessions, and 
log on to the Brain HQ site. They may call subjects to remind 
them of group sessions.  The SES will gather Check-In 
information at 3-, 9-, and 15-months. He or she will engage in 
all SE activities as usual (these activities are not part of the 
research study). The SES will collect information from the 
WBI and data on employment (i.e., job obtainment, number 
of hours worked per week, compensation per hour) in the 
course of SE activities, as standard of care measures.  
Independent Assessors will perform the follow-up 
assessments for this study (at 6-months, 12-months, and 18-
months) and assist in conducting check-ins. They may 
obtain informed consent and assist in recruitment activities. 
Independent Assessors will be blinded to treatment 
condition. The Counseling Psychologist Supervisor (Dr. 
Aaron Brinen) will provide ongoing supervision to the SES 
regarding integrated cognitive behavior therapy. He will 
review videotaped therapy sessions. The SES Consultant 
(Richard Toscano) will provide ongoing consultation 
services regarding Supported Employment activities. He will 
conduct SE fidelity measurements throughout the study, 
which will include contact with research participants. The 
DMU Administrators (Christopher Petro and Ming Li) will 
provide ongoing support related to the VA DMU server.  In 
this role they will have access to coded study data. This data 
will include visit date, which is the only identifying 
information stored on the DMU server. The co-investigator 
(Virginia “Jennie” Keleher) will provide hands-on 
supervision and guidance regarding Supported Employment 
activities. She will interact with research participants during 
evaluations of our Supported Employment Specialists.  
9.6. 
Will informed consent be obtained from potential subjects prior to determining eligibility?         
YES     
NO     
N/A 
9.6.1. 
If no, provide justification and a HIPAA Waiver of Individual Authorization for 
Disclosure of Protected Health Information.        
9.7. 
Define when a subject is enrolled into the study, e.g. after the subject signs the 
informed consent or after randomized to treatment. After all eligibility requirements 
have been verified and informed consent and HIPAA authorization has been 
provided, the patient will be considered enrolled into the study. 
9.8. 
Describe:  
9.8.1. 
The process when informed consent will be obtained and protecting patients’ 
privacy. After subjects are referred to the research study team, they will 
be scheduled for a baseline assessment, to determine eligibility for the 
treatment phase of the research study. At this appointment, which will 
be conducted in a private room, informed consent will be obtained and 
documented by the research coordinator. Consenting patients will be 
administered a baseline assessment battery (diagnostic, work 
outcomes, functional outcomes, symptom, neurocognitive, and attitude 
measures) to determine eligibility. Subjects will be told of their eligibility 
status for the treatment portion of the research study by phone within 2 
weeks of their baseline assessment. Eligible and willing subjects will be 
scheduled for a consenting appointment for the treatment portion of the 
study, which will be conducted and documented by the research 
coordinator. Eligible subjects who give a second informed consent will 

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be randomly assigned to receive either iCBT or to receive usual care. It 
may take several weeks to accumulate enough eligible and willing 
subjects to form a treatment group (i.e., 6-8 participants); participants 
will be contacted by phone to inform them of the start of the treatment 
groups. Subjects will be invited to participate in follow-up assessment 
procedures, as documented in the informed consent documents, at 6-
months, 12-months, and 18-months after treatment groups begin. The 
research coordinator will review informed consent documents at these 
follow-up assessment appointments. A 15-minute check-in will occur at 
baseline by the Research Coordinator, then at 3-, 9-, and 15- months 
after treatment groups begin by the SES, and at 6-, 12-, and 18-months 
after treatment groups begin  by an Independent Assessor. 
9.8.2. 
Any waiting period between informing the prospective participant and 
obtaining consent. Not Applicable. 
9.8.3. 
Steps taken to minimize the possibility of coercion or undue influence.  
Consent will be sought only under circumstances that provide the 
prospective participant sufficient opportunity to consider whether or not 
to participate. The information that is given to the participant shall be in 
language understandable to the participant.  The informed consent does 
not include any exculpatory language through which the participant is 
made to waive or appear to waive any of the participant’s legal rights.  
The informed consent does not release or appear to release the 
investigator, the sponsor, the institution, or its agents from liability for 
negligence. 
9.9. 
Provide the language  
9.9.1. 
used by those obtaining consent English; we will use simple language at 
no higher than a 5th grade level to minimize misunderstandings with 
participants. 
9.9.2 
understood by the prospective participant or the legally authorized 
representative English, we will use simple language at no higher than a 
5th grade level to minimize misunderstandings with participants. 
9.10. Provide location where informed consent will be obtained. In the PI’s office or in a 
private office within the Mental Illness, Research, Education, and Clinical Center 
(MIRECC). 
 
10. 
Waiver or Alteration of Informed Consent Requirements/Waiver of Requirement to 
Obtain Documentation of Informed Consent 
10.1. Are you requesting a waiver or alteration of informed consent? (Check all that apply) 
10.1.1. 
No 
 
10.1.2. 
Yes; provide justification. 
        
10.1.3. 
Yes; for recruitment purposes only.   
 
10.2. Are you requesting a waiver to obtain documentation of informed consent? 
10.2.1. 
No 
 
10.2.2. 
Yes; provide justification. 
 
 
S. Compensation (The amount of compensation may not constitute an undue inducement to participate in 
the research.) 
1. 
Summarize any financial compensation that will be offered to subjects. Subjects will receive 
$40.00 for each assessment visit completed.  
 
2. 
Provide the schedule for compensation. Subjects will receive compensation at each 
assessment, including the initial assessment, and at the 6, 12, and 18 month follow-up 
assessments. Subjects will not receive compensation for participation in the CBT, usual 
care, or SE treatment components of the study, or for check-ins. 
2.1. 
Per study visit or session. See above, $40.00 per assessment completed 

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2.2. 
Total amount for entire participation. $160 over the 2 year study. 
 
3. 
Explain how compensation will be provided via cash, voucher, gift card, etc.  The subjects will 
receive a VA voucher that can be redeemed at the Cashier for cash. 
 
4. 
If financial compensation will be prorated, explain the process.  N/A 
 
5. 
Not Applicable - 
 
 
T. Withdrawal/Early Withdrawal 
1. 
Describe how and when a subject may withdrawal from the study.  Subjects may withdraw 
from the study at any time without consequences by contacting the PI in writing. 
Subjects may also inform any research staff member of their desire to discontinue their 
participation in the research study at any time. Staff members will then inform Dr. 
Sayers. 
 
2. 
Provide procedures for the orderly termination of participation by the participant and if any 
consequences would result from early withdrawal from the study.  Subjects may withdraw 
from the study at any time without consequences. Subjects who terminate from study 
treatment, but who are willing to remain active in the assessment portion of the 
research, will be followed by phone and encouraged to attend assessment visits at 6-
months, 12-months, and 18-months after treatment groups begin, and check-ins at 3-, 6-, 
9-, 12-, 15-, and 18-months after treatment groups begin.  They will be referred back to 
their treatment team who will have been following them during their participation and 
kept informed of any study related matters. 
 
3. 
Explain if survival data is required.  If so, clarify how data will be obtained. Not Applicable. 
 
4. 
Not Applicable; subjects not recruited; chart review.  
 
 
U. Risk/Benefit Assessment 
1. 
Potential Study Risks 
1.1. 
Describe and assess all of the following risks that may be associated with the research: 
1.1.1. 
Physical– Assessment procedures at baseline are expected to take 
approximately 4-5 hours, while follow-up assessment sessions are 
expected to take approximately 3-4 hours. Check-ins will take 
approximately 15-minutes.Therapy sessions will take approximately 1 
hour. Subjects may become uncomfortable during periods of prolonged 
sitting, and will be encouraged to requests breaks whenever necessary. 
Research staff will frequently check-in with subjects to determine if a 
break is necessary, and will be encouraged to supply breaks if they feel 
this is in the best interest of the subject. 
1.1.2. 
Psychological - Subjects may experience anxiety while completing the 
assessments or during iCBT sessions. They may feel uncomfortable 
answering questions, and may refuse any such questions. They may also 
feel tired or frustrated during the computerized training. They may be 
frustrated or stressed by the demands of looking for and maintaining 
employment in the SE setting. Subjects may become frustrated or angry 
with each other in the group setting.   
1.1.3. 
Social - NA 
1.1.4. 
Economic -NA 
1.1.5. 
Monetary - NA 
1.1.6. 
Legal  - NA 
1.1.7. 
Loss of confidentiality There is a risk for breaches of confidentiality, 
especially in the setting of group treatment. All efforts will be taken to 

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minimize this risk (i.e., secure storage of research documents, reviewing 
confidentiality in the therapy groups).  
1.1.8. 
Assess the likelihood and seriousness of such risks. – The likelihood of 
physical and psychological risks occurring is high, however the 
seriousness of these risks is considered minimal. The likelihood of a loss 
of confidentiality is moderate (given the group therapy session); the 
seriousness of this risk is considered moderate.  
1.1.9. 
Other– There may be other unforeseen risks. Subjects and the IRB will be 
notified in a timely manner if additional risks are discovered. 
1.2. 
Specify what steps will be taken to minimize these risks. Subjects will be counseled 
by their supported employment specialist/therapist if they are experiencing 
stress or agitation. They will be allowed to leave a group at any time if they feel it 
is necessary. As is part of the supported employment program, employment 
specialists will advocate for subjects with the employer should the subject be 
experiencing extra stress. This will be routinely done as part of the supported 
employment paradigm and not because the subject is involved in a research trial.  
If a subject becomes severely agitated, he or she will be brought to the 
emergency room for psychiatric evaluation by study staff and VA police.  
1.3. 
If methods of research create potential risks, describe other methods, if any, that were 
considered and why they will not be used.  Group interventions incur more risks 
than individual interventions, such as breaches of confidentiality and friction 
between group members. However, the benefits of a group approach to CBT and 
cognitive remediation outweigh the risks. The benefits relate to the additional 
learning subjects do in the group setting.  
1.4. 
If chart review, breach of confidentiality is always a concern.  Specify what steps will be 
taken to minimize these risks.  Not Applicable. 
 
2. 
Potential Study Benefits 
2.1. 
Assess the potential benefits to be gained by the individual subject, as well as benefits 
that may accrue to society in general as a result of the planned work.  Although 
antipsychotic medications have been readily available for more than half a 
century, the impact of these agents on functional outcomes has been modest, 
even when medication regimes have been optimized. By contrast, psychiatric 
rehabilitation programs have been shown to improve psychosocial functioning. 
Vocational rehabilitation services, in particular supported employment (SE), have 
the best evidence base. As compared to those patients not participating in such 
services, subjects successfully engaged in SE are more likely to be working 
competitive jobs, working full time, earning higher wages, and reporting a higher 
quality of life. Furthermore, steady employment has been shown to generate 
significant savings in the use of mental health services use compared to subjects 
who are minimally employed. 
2.2. 
If the subject does not receive any direct benefit, then it must be stated here and in the 
consent form.  Not Applicable. 
 
3. 
Alternate Procedures 
3.1 
Describe the alternatives available to the subject outside the research context.  The 
alternative for subjects is not to participate in the study and to continue treatment 
as usual with their clinical team receiving medications, supported employment, 
and therapy as prescribed routinely. 
3.2 
If none, state that the alternative is not to take part in this research study at all. Not 
Applicable. 
 
V. Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) (All Phase III 
studies are required to have a DSMB.  However, the IRB has the right to require a DSMB with any 
study.) 

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1. 
Will an independent DSMB or DMC oversee the project?  
YES     
NO 
N/A 
1.1. 
If yes, please provide contact information for the DSMB or DMC or Coordinating Center 
Representative and attach a copy of the charter. 
              
Name:                                              
Phone Number:        
             
Title:                                                     
E-mail:        
 
2. 
If a DSMB or DMC will not monitor this study, who will monitor this study? Check all that 
apply. 
 
 
 Principal Investigator 
 
 
 Sponsor  
 
 
 VA Cooperative Studies Program 
 
 
 Safety monitoring committee 
 
W. Data Monitoring (Monitoring plans describe how a monitor, independent of the study team, regularly 
inspects study records to ensure the study is adhering to the study protocol and applicable research 
regulations and CMCVAMC requirements.  Monitoring plans do not necessarily require the use of an 
independent Data and Safety Monitoring Board (DSMB).  Such independent boards are usually 
reserved for high-risk phase I studies, or large, multi-center phase III trials.  Federally funded studies 
may require the use of an independent DSMB.)   
1. 
Describe the data monitoring plan (All protocols must have a data monitoring plan appropriate 
for the potential risks and the complexity of the study.) The PI and the rest of the study team 
will perform regular data monitoring to inspect study records to ensure the study is 
adhering to the study protocol and applicable research regulations and CMCVAMC 
requirements. This data monitoring will occur monthly and be overseen by the PI. 
 
2. 
Describe how protocol deviations, adverse events, serious adverse events, breaches of 
confidentiality, unanticipated adverse device effect (UADE), and unanticipated or 
unexpected problems will be reported to the CMCVAMC IRB and sponsor (Refer to the 
CMCVAMC IRB Standard Operating Procedure (SOP) Manual for reporting guidelines.)   
Protocol deviations, serious adverse events, unanticipated or unexpected problems and 
breaches of confidentiality will be reported to the CMCVAMC IRB via email using the 
appropriate CMCVAMC forms in a timely manner (no more than 5 days) after learning of 
the event. Adverse events that are not considered serious will be reported to the IRB at 
the time of continuing review.    
2.1. 
Describe the management of information obtained that might be relevant to participant 
protections such as: 
2.1.1. 
Unanticipated problems involving risks to subjects or others: We will update 
the informed consent form and make existing subjects aware of the new 
information through a revised informed consent procedure. 
2.1.2. 
Interim results: We will update the informed consent form and make 
existing subjects aware of the new information through a revised 
informed consent procedure. 
2.1.3. 
Protocol modifications: We will update the informed consent form and 
make existing subjects aware of the new information through a revised 
informed consent procedure. 
 
3. 
If applicable, define the plan for subjects if research shows results such as: 
3.1. 
Unanticipated problems involving risks to subjects or others – Subjects and the IRB 
will be informed in a timely manner (as above) should any unanticipated risks to 
subjects be identified.  
3.2. 
Interim results- The IRB will be notified of interim results at the time of continuing 
review. 
3.3. 
Protocol modifications The IRB will be notified of requests for protocol modification 
prior to the institution of any modified procedures, either at the time of continuing 
review or in a stand-alone amendment request. Subjects will be notified in a 

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timely manner about any protocol modifications that have a direct impact on 
research subjects (e.g., changes to consent form). If necessary, informed consent 
will be re-obtained.  
 
To ensure the safety of participants, review of all collected information in the form of 
surveys and interview data will be conducted by study staff.  If any current evidence of 
major depression, suicidal ideation, or homicidal ideation with no intent is present, this 
information will be discussed with the participant by a psychiatrist or doctoral level 
psychologist. The information will be provided to their mental health care provider for 
follow-up.  In the case that a subject does not have a mental health care provider (e.g., 
they have left care against advice and/or after enrollment in the research study) they will 
be referred appropriately for treatment.  If indicated, assistance will be provided in 
making this contact. If suicidal ideation or homicidal ideation with intent is present or 
there are reports of abuse of a child or elder, the participant will be referred for 
evaluation in the nearest emergency room and the treating mental health care provider 
will be notified.  In emergent situations, emergency assistance will be sought from 
hospital security and/or by contacting 911 emergency services. Subjects may be 
withdrawn from the study if they are considered a risk to themselves or others. Subjects 
may continue with the study if they are psychologically stable, even if they do not have a 
current treating psychiatrist. However, they will be encouraged to reestablish clinical 
care. 
 
4. 
Statistical Analysis 
4.1. 
Include statistical power calculations and the assumptions made in making these 
calculations.  
Power analysis 
For the primary outcome variable (composite index of workforce participation), 
and secondary outcome, Work Behavior Inventory (WBI), we used an uncorrected 
alpha level (Type 1 error rate) of 0.05 in designing our study. There are many 
different perspectives on adjusting for multiple comparisons in general, and 
randomized trials in particular. A number of researchers believe that with a 
primary outcome and all other outcomes treated as secondary (i.e., exploratory) 
there is no need for multiple comparisons. 
 
This study is powered to detect a clinically significant difference between iCBT 
and the usual care conditions. Meta-analysis of medical and behavioral outcomes 
indicates that a medium effect-size between conditions will have a significant 
impact on quality of life. In a previous study we observed an average effect of 
about d=0.55 SD. To allow for a somewhat smaller effect in this proposed study, 
we design our study to have 80% power to detect clinically significant effect of 
d=0.5 SD. In the pilot data, we found a within-subject correlation structure 
consistent with a stationary autoregressive process with correlation parameter 
0.4. We also assume a dropout rate of 20% for these power calculations. With 
these assumptions on effect size, covariance structure, and dropout rates, and 
with a two-sided alpha level of 0.05, the methods of Hedeker et al.86 estimate that 
a sample size of 48 subjects per group will provide 80% power for the test of our 
primary hypothesis. 
 
We believe that this is a conservative estimate, based on the larger effect size 
observed in our prior study, and the higher than expected dropout rate used in 
the calculation, In addition, our analyses will use the baseline measure of 
Psychosocial Functioning as a covariate, which should reduce the standard 
errors in our test, and therefore increase the smallest detectable effect size. 
 

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4.2. 
Define plans for data and statistical analysis, including key elements of the statistical 
plan, stopping rules and endpoints.  
Planned Analyses 
 
(i) Overview 
Logistic, log-linear and linear random effects models (hierarchical regression 
models) will be implemented with random intercepts and slopes for longitudinal 
binary, count, and continuous outcomes, respectively. These models will contain 
separate main effects for change from baseline to each follow-up visit at 6, 12, 
and 18 months, main effect for the treatment, and interactions between the visit 
and treatment indicator variables. For each of the primary (workforce 
participation indices) and the secondary (Work Behavior Inventory, Specific 
Levels of Function) outcomes, separate intent-to-treat (ITT) tests and estimates 
(with 95% confidence intervals) of randomized group contrasts at 6, 12, and 18 
months will be obtained from the estimates of the respective time-treatment 
interactions.  
 
We will assess residuals in the longitudinal linear random effects model with 
normal QQ plots and estimation of the skewness and kurtosis coefficients. If 
these are coefficients exceed their classical cut-offs of 3 and the QQ plots 
confirm skewness and/or kurtosis, we will then perform a longitudinal analysis 
based on a random effects generalized linear model with a gamma error 
distribution (with SAS Proc GLIMMIX) that handles skewed and kurtotic 
distributions. We will fit such a model with identity link function (linear mean 
model), such that the resulting estimates and tests are comparable to those of 
the normal error random effects model. We will compare the estimates and p-
values. If the two approaches agree with respect to significance at the specified 
alpha level, then we will use the results from the linear random effects model with 
normal error. If they disagree we will base results on the gamma error distribution 
model. 
 
Prior to each hierarchical analysis, baseline outcomes, pre-treatment assessment 
scores, and demographics (except gender which by definition is balanced due to 
be a stratification factor in the randomization) will be compared between the two 
treatments at the two-sided alpha = .05 level. Any significant baseline variables 
will be included as covariates in the hierarchical regression models. We will also 
perform as a sensitivity analysis based on an adjustment of the ITT models for 
post-randomization  confounding due to differences in medication patterns 
between the randomized groups. Such adjustments  will be based on a causal 
modeling approach that distinguishes between direct effects of the iCBT 
intervention, on the one hand, and  differences in medication patterns, on the 
other, using randomization and its products with baseline covariates as the 
instrumental variables to control for unmeasured confounding due to choice of 
medication. 
 
While the present study is designed to minimize lost observations, the proposed 
random effects or hierarchical regression approach is superior to last 
observation carried forward in minimizing bias and Type 1 error and inferentially 
equivalent to multiple imputation.79 To assess the sensitivity of treatment effect 
estimates to missing data, we will compare the results under the above 
hierarchical regression models with those based on shared parameter models 
that account for informative missingness that is dependent on unobserved 
outcomes through a latent variable.80 If the results between the two approaches 
are similar then we will present the proposed hierarchical regression models as 
robust to informative missing data; otherwise we will note that the results may be 

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sensitive to informative missing data and augment them with those based on the 
shared parameter model.  
 
(ii) Work outcome. The primary trial outcome measure, workforce participation 
(composite index) at 6, 12 and 18 months analyzed in the manner described 
above. A significant ITT difference on the total WBI score across 6 and 12 months 
would support the hypothesis that iCBT is more efficacious than usual care at 
improving work outcomes by the end of treatment (Primary Aim 1). Similarly, WBI 
score at 18 months is a secondary outcome, and a separate ITT effect on work 
outcomes at 18 months with the respective month-treatment interaction in favor 
of iCBT would support the hypothesis that it promotes better work outcomes 
than usual care during the 6 months after the completion of treatment (Secondary 
Aim 2).  
 
(iii) Functional outcome. The second trial outcome measures include the Work 
Behavior Inventory and the total score on the Specific Levels of Functioning 
Inventory (SLOF) at 12 months A significant ITT difference on the WBI and the 
total SLOF score across 6, 12 months would support the hypothesis that ICBT is 
more efficacious than usual care at improving functioning by the end of treatment 
(Secondary Aim 1). Similarly, WBI and SLOF total score at 18 months is a 
secondary outcome, and the separate ITT effects on functioning at 18 months 
with the respective month-treatment interaction in favor of iCBT would support 
the hypothesis that it promotes better functioning than usual care during the 6 
months after the completion of treatment (Secondary Aim 3).  
 
(iv) Neurocognitive performance. Following previously established procedures, 
accuracy scores of the neurocognitive domain scores most closely related to 
functioning (attention, verbal memory, and executive function) will be averaged to 
form the variable, neurocognitive performance (NP). The ITT analysis will be the 
same as for WBI. (Exploratory Aim 1). 
 
(v) Negative symptoms. The sum of the 13 items of the Brief Negative Symptom 
Scale (BNSS) will serve as the index of negative symptoms. The ITT analysis will 
be the same as for work outcomes. (Exploratory Aim 2).   
 
(vi) Mediation and moderation. We will follow the MacArthur model of identifying 
mediating and moderating variables by adding two terms to the above 
hierarchical regression models: main effects of the putative mediator on 
outcome, as well as interactive effects of the potential mediator by treatment 
condition (moderation) on outcome. With randomization and its products with 
baseline factors as instrumental variables, we also will test causally the effect of 
the intervention on outcome to see if there is full mediation (main effect of 
treatment is not significant) or partial mediation (main effect of treatment is still 
significant). Additionally, mediation analysis requires appropriate temporal 
ordering such that the mediator changes prior to the change in outcome that it 
putatively causes.83 Four classes of model will be tested: (a) whether change in 
symptoms (mediators = SAPS total and BNSS total) mediates subsequent change 
in work outcomes or functional outcome (DVs = Workforce participation 
compositive, WBI total, SLOF total) [Exploratory Aim 3], (b) whether change in 
neurocognition (mediator = composite score) mediates subsequent change in 
work outcome or psychosocial functioning (DVs = Workforce participation 
compositive, WBI total, SLOF total) [Exploratory Aim 4], (c) whether change in 
dysfunctional attitudes (mediators = defeatist beliefs, asocial beliefs) mediates 
subsequent change in work outcomes and psychosocial functioning or 
symptoms (DVs = Workforce participation compositive, WBI total, SLOF total) 

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[Exploratory Aim 5], (d) whether baseline prognostic variables predict treatment 
response independent of treatment condition and whether prescriptive factors 
predict differential treatment response (prognostic/moderator variables = illness 
duration, neurocognition, emotion recognition, cognitive insight, defeatist 
beliefs; DVs = Workforce participation compositive, WBI total, SLOF total) 
[Exploratory Aim 6]. 
 
X. Privacy and Confidentiality (Privacy refers to persons and to their interest in controlling the access 
of others to themselves.) (Confidentiality refers to protecting information from unauthorized disclosure 
or intelligible interception.) (Investigator should contact the Privacy Officer for additional details.) 
1. 
Indicate the type of data that will be received by the Principal Investigator.  Check all 
that apply. 
1.1. 
 De-identified – Without any identifiers that could link the data to a specific 
participant.  (Contact Privacy Officer for assistance.  If data is coded, it is not 
considered de-identified.) 
1.2. 
 Identified – Linked to a specific participant by identifiers sufficient to identify          
participants.  (See HIPAA and Common Rule Criteria for list of identifiers.) 
1.3. 
 Coded – Linked to a specific subject by a code rather than a direct identifier. If coded 
is checked, specify:  
1.3.1 
Explain who will maintain the link or code. The code key will be maintained 
by the principal investigator and research coordinator on a mapped 
network drive on a secure VA server (i.e., \\VHAPHIFPCMIRECC 
\Research Studies\Sayers -Integrated CBT to Improve Work). 
1.3.2 
Describe who will have access to the link or code. The study staff will have 
access to and maintain the code.  
1.3.3 
Provide exact details for how the data is coded. Data will be coded by 
assigning subjects a study number based on consent order upon 
entrance into the study. The code will be kept separate from the rest of 
the data. In addition, when subjects who are in the CBT treatment arm are 
logged on to the Brain HQ server by their SES, they will be assigned a 
separate coded number, which will be maintained by the CMCVAMC 
study staff and not accessible by Posit Science at any time. CNB data are 
uploaded automatically to the VA MIRECC secure server using PGP 
encryption and reviewed for validity (i.e., \\VHAPHIFPCMIRECC \Research 
Studies\Sayers -Integrated CBT to Improve Work).  
 
2. 
Does the project require the use of existing Protected Health Information (PHI) from a 
database, medical records, or research records?  
YES     
NO    
N/A 
2.1. 
If yes, 
2.1.1. 
Specify the source of the existing PHI CPRS  
2.1.2. 
Indicate the specific data elements/identifiers (e.g., name, address, phone 
numbers, etc.) on the below table.  
2.2. 
If the study uses an existing database/data warehouse, 
2.2.1. 
Provide a description of the database/data warehouse.  Not Applicable 
2.2.2. 
Make clear who is responsible for maintaining it. Not Applicable 
2.2.3. 
Cite any relevant Standard Operating Procedures (SOP) for the database/data 
warehouse.   Not Applicable 
2.2.4. 
Provide a copy of the SOP.    
 
3. 
Will PHI be collected prior to obtaining informed consent?  
YES     
NO    
N/A 
3.1. 
If yes, complete and provide a HIPAA Waiver of Individual Authorization for Disclosure 
of Protected Health Information with this submission. 
 
4. 
HIPAA Identifiers - Indicate the PHI that will be collected from project participants directly or 
indirectly. 

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4.1. 
 Name 
 
4.2. 
 All geographic subdivisions smaller than a State, including street address, city, 
county, precinct, zip code, and their equivalent geocodes, except for the initial three 
digits of a zip code if, according to the current publicly available data from the Bureau of 
the Census 
4.3. 
  All elements of dates (except year) for dates directly related to an individual, and all 
ages over 89 and all elements of dates (including year) indicative of such age, except 
that such ages and elements may be aggregated into a single category of age 90 or 
older.  
4.3.1. 
 Birth Date 
 
 Date of Death 
4.3.2. 
 Discharge date 
 Admission date 
4.3.3. 
 Appointment Dates 
 Other Dates (e.g. lab tests, x-rays, MRI, etc.)       
4.4. 
 Telephone numbers 
 
4.5. 
 Fax numbers 
4.6. 
 Electronic mail addresses 
 
4.7. 
 Social Security/Medical Record Number 
4.8. 
 Health plan beneficiary numbers 
 
4.9. 
 Account Numbers 
4.10. 
 Certificate/license numbers 
4.11. 
 Vehicle identifiers and serial numbers, including license plate numbers 
4.12. 
 Device identifiers and serial numbers 
4.13. 
 Web universal resource locators (URLS) 
4.14. 
 Internet protocol (IP) address numbers 
4.15. 
Biometric identifiers, including fingerprints, voiceprints, audio recordings 
4.16. 
Full-face photographic images and any comparable images 
4.17. 
 Any other unique identifying number, characteristic, or code 
4.18. 
 Personal and Family History 
 
4.19. 
 History and Physical Examination 
 Progress Notes 
4.20. 
 Discharge Summary(ies) 
 
 Photographs, videotapes, other  images 
4.21. 
 X-Ray 
 
 HIV (testing or infectious disease) records 
4.22. 
 Diagnostic/Laboratory tests 
 
 Sickle cell anemia 
4.23. 
 Drug Abuse Information 
 
 Behavioral Health notes 
4.24. 
 Alcoholism or Alcohol Use 
 
 Operative Reports 
4.25. 
 Billing records 
 
 Medication List 
4.26. 
 Health Summary Reports  
 
 Anatomic Pathology Report 
4.27. 
Other Records: Supported Employment records 
 
5. 
Will participants be contacted from existing PHI?  
YES    
NO    
N/A 
5.1. 
If yes, clearly explain how participants will be contacted (NOTE: this would be the same 
information as listed under section R.8 identification and recruitment of subjects).  
Potential participants will be identified through the outpatient mental health 
clinic, the inpatient psychiatric unit, and the Compensated Work Therapy (CWT) 
program at the CMCVAMC. Identification of potential research participants will be 
two-fold: (1) the research team will conduct a review of the caseloads of the 
treating psychiatrists in the CMCVAMC outpatient mental health clinic and 
inpatient psychiatric unit via CPRS review under a Waiver of Individual 
Authorization for Disclosure of Protected Health Information. The research team 
will communicate securely (e.g., via CPRS, encrypted email, secure server) 
regarding patients who may be eligible for the research study, and confer on the 
appropriateness of research participation; (2) treating psychiatrists in the 
outpatient mental health clinic and inpatient psychiatric unit will identify 
potentially eligible participants based on interest in SE and interest in learning 
about research. In either case, treating psychiatrists at the outpatient mental 
health clinic and inpatient psychiatric unit will refer individuals with SMI as per 
CMCVAMC standard protocol to the CWT program.  (This referral would be made 

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regardless of eligibility in the research study.) Providers who refer potentially 
appropriate Veterans will ask them if they would consider participating in the 
research study. The study team will remind the clinician that they should 
document this referral in the patient’s chart.  Those who agree will be approached 
by the research staff (the PI, RC, independent assessors, and/or the SE 
specialists) after they are referred to the CWT program through a CPRS consult 
created specifically for study referrals (i.e., SE Research Consult – Vocational 
Rehab Outpt). The consult note will remind providers that they can only refer 
patients who want to hear more about the study. The study team will receive an 
alert in the CPRS system once a study consult has been placed. The study team 
will regularly check for consults in the CPRS system. All consults will be received 
and resolved by the study team within 24 business hours, per CMCVAMC 
standard of care. Providers and the research team may also collaborate to 
identify potentially eligible participants with whom the provider has not yet 
discussed SE or study participation to receive a “recruitment opt-in letter” 
describing study participation and requesting that Veterans contact their treating 
providers and/or the study team to learn more about the study. Study referrals 
will follow guidelines outlined above and below should the Veteran reach out to 
their provider and/or the research team to learn more about participation. 
 
6. 
Provide the titles of the exact individuals who will have access to the collected data.  The 
following members will have access to the data: The PI, the Research Coordinator, the 
Independent Assessors, the Supported Employment Specialists, the Co-investigator, the 
Counseling Psychotherapist Supervisor, the Supported Employment Consultant, the co-
investigator, the study biostatistician and the DMU administrators. Our study consultant, 
Irene Hurford, MD, will not have access to any study data. Dr. Hurford will assist in the 
interpretation of the results of analyzed data. 
6.1. 
Explain why these individual will have access to this data.  This is because these are 
the study staff that will be involved in collecting and entering the PHI into the 
database, or supervising the collection of PHI. 
 
Y. Information Security (Contact the Information Security Officer for additional assistance regarding 
confidentiality (storage/security) of research data.) 
1. 
Provide the precise plan how data is to be collected or acquired (repeat the same information 
as listed under “Data Collection” section of this form. At the baseline assessment interview, 
a member of the research team (PI, Co-I, or research coordinator) will administer a 
comprehensive, face-to-face interview that allows for a reliable diagnosis of 
schizophrenia and queries subject psychosocial functioning levels, symptomatology, 
substance use, service usage, and check-in.  At other assessments, the independent 
assessor will perform semi-structured interviews, collect questionnaire data, administer 
cognitive and performance tests, and complete the check-in. The Supported 
Employment Specialists will complete the check-ins after treatment groups begin, which 
are not tied to an assessment (i.e., at 3-months, 9-months, and 15-months). They will 
collect data from the WBI at baseline, and at 6-months, 12-months, and 18-months after 
treatment groups begin (obtained in the course of standard SE care). 
 
Some data (e.g., demographics, diagnosis, study enrollment and tracking) will be stored 
on the centralized VA server and uploaded daily (i.e., \\VHAPHIFPCMIRECC \Research 
Studies\Sayers -Integrated CBT to Improve Work). Research data from the 
questionnaires and some study scales (e.g., SAPS, BSES-SF) will be collected 
electronically via web interface, a password protected website run within the CMCVAMC 
firewall and stored on the VHAPHIFOCMIRECC direct-entry data server. The server is 
maintained by CMCVAMC FITS.  Interview data and self-report data are entered directly 
onto computers at the research site, by research technicians and study subjects 
respectively. The technician will be present with the subject through the entire 

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assessment, and will review each instrument as it is completed. CNB data are uploaded 
automatically to the VA MIRECC secure server using PGP encryption and reviewed for 
validity (i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to Improve 
Work).  
 
Data from the cognitive remediation program will also be stored on the Posit Science 
server for quality assurance/quality improvement analysis of the program by the Posit 
Science Company. All data sent to Posit Science will be coded and the code will not be 
available to them. The participants will be logged on to the Brain HQ server (by their SE 
specialist) using a coded number, separate from their study ID number. The Posit 
Science/Brain HQ Company will have no access to the study ID number at any time and 
will not be able to de-code the data in any way. No identifying information will be 
included with the data stored on the Posit Science server 
(https://portal.brainhq.com/?study=best_vet). Data will be saved on the VA server (i.e., 
\\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to Improve Work). 
 
Media recordings of the therapy sessions will be stored on the centralized VA server and 
uploaded daily (i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to 
Improve Work). Recordings will include the subjects’ faces, bodies, and voices.  
 
December 2015 amendment to change data storage location: Due to a system failure of 
the DMU at the VA, which was the main interface for entering research data for clinical 
studies for Behavioral health / MIRECC, an amendment to this ongoing protocol was 
made to change where data was stored (as detailed above and in below sections that 
describe data storage).  This is being done with the input from the ISO and PO, and 
under the current PENN-VA MOU on data storage (even though there is a separate PENN 
component to our study). The need to use the DMU at Penn is critical because the use of 
is pen/paper has many problems related to privacy and errors and storage. 
 
Data from the 2 subjects enrolled, but not randomized, will not go to Penn. Data from the 
2 subjects randomized, but not active, will not go to Penn. We will re-consent all active 
subjects (n=6); data for these subjects will only be entered in to the Penn DMU server 
after re-consent/agreement from participants.  
 
We also note that there was no data loss due to the VA DMU failure. 
 
April 2016 Amendment to change data storage location from Penn’s Data Management 
Unit (DMU) back to VA DMU.  NOTE:  VA DMU server issues were fixed prior to 
finalization of UPenn DMU server for this study; no participant data was entered in the 
UPenn DMU server. 
 
2. 
Provide a listing of the exact research data that will be stored, including but not limited to 
signed, original informed consent and HIPAA authorization forms, case report forms, etc.  
Informed Consent Forms, HIPAA authorizations, tests, recorded sessions, and 
questionnaires/surveys. 
 
3. 
Indicate how project’s research data (original and all copies) will be stored and provide 
corresponding security systems.  The participant’s research records containing any 
personal health information will never leave the VA grounds.  Hard copies of consents, 
HIPAA authorizations, tests, and surveys, and recorded sessions, will be stored inside 
of a locked cabinet in the principal investigator’s locked office at the VA in the MIRECC 
of the CMCVAMC. Some electronic data, including overall study tracking files, will be 
maintained on the CMCVAMC secure server (i.e., \\VHAPHIFPCMIRECC \Research 
Studies\Sayers -Integrated CBT to Improve Work). The data will be coded and the code 
will be maintained separate from the rest of the data, locked in a cabinet in the MIRECC.  

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CNB data are uploaded automatically to the VA MIRECC secure server using PGP 
encryption and reviewed for validity (i.e., vhaphiwebcnp2.v04.med.va.gov/). Data from 
the cognitive remediation program will also be stored on the Posit Science server for 
quality assurance/quality improvement analysis of  the program by the Posit Science 
Company. All data sent to Posit Science will be coded and the code will not be available 
to them. The Posit Science/Brain HQ Company will have no access to the study ID 
number at any time and will not be able to de-code the data in any way. No identifying 
information will be included with the data stored on the Posit Science 
server(https://portal.brainhq.com/?study=best_vet). Data will be saved on the VA server 
(i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to Improve Work). 
Research assessment data (including questionnaire data, clinical assessment data – 
including use of alcohol/substances, performance measures, supported employment 
tracking and fidelity ratings, and treatment group tracking data) will be housed on the 
VA DMU server ; data will be uploaded to the secure MIRECC server at least quarterly, 
for long-term storage (i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated 
CBT to Improve Work).  NOTE:  VA DMU server issues were fixed prior to finalization of 
UPenn DMU server for this study; no participant data was entered in the UPenn DMU 
server. 
 
4. 
Provide exact location where research data (original and all copies) will be stored and secured.   
Physical research data will be stored in the MIRECC, CMCVAMC. Some electronic data, 
including overall study tracking files, will be maintained on the CMCVAMC secure 
server. CNB data are uploaded automatically to the VA MIRECC secure server using 
PGP encryption and reviewed for validity (i.e., \\VHAPHIFPCMIRECC \Research 
Studies\Sayers -Integrated CBT to Improve Work). The data will be coded and the code 
will be maintained separate from the rest of the data, locked in a cabinet in the MIRECC. 
Data from the cognitive remediation program will also be stored on the Posit Science 
server for quality assurance/quality improvement analysis of  the program by the Posit 
Science Company. All data sent to Posit Science will be coded and the code will not be 
available to them. The Posit Science/Brain HQ Company will have no access to the study 
ID number at any time and will not be able to de-code the data in any way. No identifying 
information will be included with the data stored on the Posit Science server 
(https://portal.brainhq.com/?study=best_vet). Data will be saved on the VA server (i.e., 
\\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to Improve Work). 
Research assessment data (including questionnaire data, clinical assessment data – 
including use of alcohol/substances, performance measures, supported employment 
tracking and fidelity ratings, and treatment group tracking data) will be housed on the 
VA DMU server; data will be uploaded to the secure MIRECC server at least quarterly, for 
long-term storage (i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT 
to Improve Work). 
 
5. 
Explain how data is to be transported or transmitted from one location to another.  Data from 
the cognitive remediation program will be stored on the Posit Science server for quality 
assurance/quality improvement analysis of the program by the Posit Science Company. 
All data sent to Posit Science will be coded and the code will not be available to them. 
The Posit Science/Brain HQ Company will have no access to the study ID number at any 
time and will not be able to de-code the data in any way. No identifying information will 
be included with the data stored on the Posit Science server 
(https://portal.brainhq.com/?study=best_vet). Data will be saved on the VA server (i.e., 
\\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT to Improve Work). 
Research assessment data (including questionnaire data, clinical assessment data – 
including use of alcohol/substances, performance measures, supported employment 
tracking and fidelity ratings, and treatment group tracking data) will be housed on the 
VA DMU server; data will be uploaded to the secure MIRECC server at least quarterly, for 

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long-term storage (i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -Integrated CBT 
to Improve Work). 
5.1. 
Informed Consent discloses PHI transported or transmitted off-site.  
YES  
NO  
N/A 
5.2. 
HIPAA Authorization discloses entities to whom PHI will be transported or transmitted.  
YES  
NO  
N/A 
5.2.1. 
List all entities or individuals outside CMCVAMC to whom data is to be 
disclosed, and the justification for such disclosure and the authority:  
5.3. 
If yes, list the exact data that will be transmitted:  
5.4. 
If yes, explain how data will be protected during transmission outside of CMCVAMC:  
5.5. 
Off-site, provide exact location (If off-site, attach at least one of the following.) 
5.1.1. Data Use/Transfer Agreement 
YES    
NO    
N/A 
5.1.2. Off-Site Storage/Transfer of Research Data 
YES    
NO    
N/A 
5.1.3. Memorandum of Understanding 
YES    
NO    
N/A 
5.1.4. (Note: VA data disclosed to a non-VA investigator at an academic affiliate for 
research purposes needs to be approved by the Under Secretary of Health or 
designee.) 
 
6. 
List who is to have access to the data and how they are to access it (anyone who has access 
to the data is responsible for its security).  The following members will have access to the 
data: The PI (Dr. Sayers), the RC, the Co-investigator (Dr. Grant), the SES, the 
Independent Assessors, the Counseling Psychotherapist Supervisor (Dr. Brinen), the SE 
Consultant (Richard Toscano), the co-investigator (Virginia “Jennie” Keheler) and the 
study biostatistician (TBD).  They can access the hard copies kept in the MIRECC, as 
well as the electronic copies on the secure server. Our study consultant, Irene Hurford, 
MD, will not have access to any study data.  
7. 
Describe who is to have access and be responsible for the security of the information (e.g., the 
Coordinating Center, the statistician, and PI who has ultimate responsibility).  The following 
members are responsible for the security of the data: The PI (Dr. Sayers), the RC, the 
independent assessors, the supported employment specialists, the Co-investigator (Dr. 
Grant), the Counseling Psychotherapist Supervisor, the SE Consultant, the co-
investigator, and the study biostatistician (TBD). 
 
8. 
Provide mechanisms used to account for the information.  Only the above-named study staff 
will have access to the information. 
 
9. 
Give security measures that must be in place to protect individually identifiable information if 
collected or used. The participant’s research records containing any personal health 
information will never leave the VA grounds.  Hard copies of consents, HIPAA 
authorizations, tests, and surveys will be stored inside of a locked cabinet in the 
principal investigator’s locked office at the MIRECC, CMCVAMC. Some electronic data, 
including overall study tracking files, will be maintained on the CMCVAMC secure 
server. Research assessment data (including questionnaire data, clinical assessment 
data – including use of alcohol/substances, performance measures, supported 
employment tracking and fidelity ratings, and treatment group tracking data) will be 
housed on VA DMU server ; data will be uploaded to the secure MIRECC server at least 
quarterly, for long-term storage (i.e., \\VHAPHIFPCMIRECC \Research Studies\Sayers -
Integrated CBT to Improve Work).The data will be coded and the code will be maintained 
separate from the rest of the data, locked in a cabinet in the MIRECC. 
 
10. 
How and to whom a suspected or confirmed loss of VA information is to be reported.   
The Investigator will notify the Information Security Officer, Privacy Officer, IRB, 
Associate Chief of Staff for Research and Research Compliance Officer within one hour 
of a suspected or confirmed loss of VA information. 
 

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11. 
Identify any circumstances that may warrant special safeguards to protect the rights and 
welfare of subjects who are likely to be vulnerable including, but not limited to, those subjects 
who may be susceptible to coercion or undue influence, and describe appropriate actions to 
provide such safeguards.  Not Applicable 
 
12. 
Electronic PHI will be stored on the following: 
12.1. CMCVAMC desktop computer with password protection and/or encryption. 
YES  
NO  
N/A 
12.1.1. 
If yes, identify where the desktop is located.  
12.2. CMCVAMC secure server.  
YES  
NO  
N/A 
12.2.1. 
If yes, identify the CMCVAMC server. \\VHAPHIFPCMIRECC \Research 
Studies\Sayers -Integrated CBT to Improve Work. 
12.2.2. 
External drive that is password protected and/or encrypted.  
YES  
NO  
N/A 
12.2.2.1. If yes, identify the external drive.       
12.3. Off-Site server 
YES  
NO  
N/A (If off-site, attach at least one of the following.) 
12.3.1. 
Provide exact location and the name of the off-site server:  
12.3.2. 
Data Use/Transfer Agreement 
YES  
NO  
N/A 
12.3.3. 
Off-Site Storage/Transfer of Research Data 
YES 
NO 
N/A 
12.3.4. 
Memorandum of Understanding 
YES    
NO    
N/A 
 
13. 
Explain how data is to be transported or transmitted from one location to another.   
 
14. 
Informed Consent discloses PHI transported or transmitted off-site.  
YES  
NO  
N/A 
 
15. 
HIPAA Authorization discloses entities to whom PHI will be transported or transmitted.  
YES 
NO  
N/A 
16. 
List all entities or individuals outside CMCVAMC to whom data is to be disclosed, and the 
justification for such disclosure and the authority: Not applicable.  
 
17. 
Clarify what protection exists for a database.  PHI will be housed on secured CMCVAMC 
servers that reside behind the VA firewall.  
17.1. Data is stored: 
17.1.1. 
With identifiers - 
YES   
NO 
17.1.2. 
Coded - 
YES   
NO 
17.1.3. 
De-Identified -  
YES   
NO 
17.1.4. 
Provide the exact list of identifiers that will be stored. The list of identifiers 
that will be stored is as follows: Name; address; telephone number; 
date of birth; social security/medical record number; date of 
administration 
 
18. 
Describe the plan for protecting research data from improper use or disclosure.  Research 
data will only be accessible to research staff.  
18.1. The Investigator must notify the Information Security Officer, Privacy Officer, IRB, 
Associate Chief of Staff for Research and Research Compliance Officer within 
one hour of the improper use or disclosure. 
 
19. 
Is there a plan to apply for a Certificate of Confidentiality?  
YES    
NO    
N/A 
19.1. If yes, provide a copy of the certificate with this application or to the IRB Office as soon 
as received.        
 
20. 
Record Retention:   
20.1. The required records, including the investigator’s research records, must be retained 
until disposition instructions are approved by the National Archives and Records 

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Administration and are published in VHA's Records Control Schedule (RCS 10-1).  VHA 
Handbook 1200.05 §26.h  
20.2. Until a schedule for local research records is published, ALL records including 
identifiers must be retained.” ORO/ORD Guidance on Informed Consent Form 
Modifications Addressing VA Record Retention Requirements (July 23, 2009)  
20.3. If there are additional procedures for record retention, explain further.  N/A 
 
Z. Qualification of the Investigators 
1. 
Provide a description of the qualifications of each investigator/co-investigator and their specific 
role in the study. Principal Investigator, Steven Sayers Ph.D.  Dr. Sayers is the Director of 
the Advanced Fellowship Program in Mental Illness Research and Treatment, and 
investigator and Co-Associate Director of Education for VISN4.  
 
Co-Investigators:  
 
Dr. Grant developed the iCBT model. He has a long track record of research into 
CBT for psychosis with Dr. Aaron Beck. He will provide all the CBT trainings and 
monitor for fidelity and reliability. He will oversee training on structured 
interviews, questionnaires and oversee reliability. He will provide clinical and 
diagnostic guidance.  
 
Ms. Keheler is an expert in the field of Supported Employment. She will provide 
supervision and evaluations for our Supported Employment Specialists/Program. 
 
2. 
If applicable, the Principal Investigator must identify a qualified clinician to be responsible for all 
study related healthcare decisions. Not Applicable 
 
3. 
PI should submit a current, dated CV with each new initial review. 
 
 
 

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