Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
Phase: NA
Conditions: Mental Disorders
Sponsor: Boston University Charles River Campus

Testing Effectiveness of a Peer-Led Intervention to Enhance Community 
Integration 
NCT02508480 
Study Protocol  
Date Updated: December 4th, 2017

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THE RESEARCH PROPOSAL 
1.
Submission Date / Version Date: September 23, 2014/ December 4, 2017
2.
Project Title: Testing Effectiveness of a Peer-Led Intervention to Enhance Community
Integration
3.
Funding/Sponsor: National Institute of Mental Health (NIMH)
 Grant Proposal MH102230-01A1 
4. Principal Investigator(s)
Principal Investigator: Zlatka Russinova, Ph.D.  
Senior Research Associate/Research Associate Professor 
zlatka@bu.edu 
Organizational Affiliation: Center for Psychiatric Rehabilitation at Boston University 
940 Commonwealth Ave., West 
Boston, MA 02215 
(617) 353-3549
5. Location(s)
The study will take place at four of the clubhouses of Riverside Community Care - 
Neponset River Clubhouse in Norwood, MA; Eliot House in Needham, MA; Horizon 
House in Wakefield, MA; and Crossroads Clubhouse in Hopedale, MA. Dr. Russinova 
(PI) and Dr. Rogers have had multiple contacts with this entity for the purpose of 
conducting this study. The following person at Riverside Community Care is the 
coordinator for this study: 
Donald E. Hughes 
Associate Director, Community Living Services Division 
Riverside Community Care 
450 Washington Street 
Dedham, MA 02026 
Phone: 781-320-5321 
dhughes@riversidecc.org 
The following are the clubhouse addresses: 

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Neponset River House 
595 Pleasant St, Norwood, MA 02062 
 (781) 762-7075  
 
Elliot House 
255 Highland Avenue 
Needham, MA 02494 
 (781) 449-1212 
 
Horizon House 
78 Water Street 
Wakefield, MA 01880 
 (781) 245-4272  
 
Crossroads Clubhouse 
11 Williams St,  
Hopedale, MA 01747 
(508) 473-4715 
 
In 2013, a pilot study entitled “Anti-Stigma Empowerment through Photovoice (ASEP)”, 
CORRC # 2012-15, was completed at the Neponset River House in Norwood, MA. A 
total of 15 non-randomized subjects were enrolled with recruitment taking place in 
January 2013 and final follow up assessments completed in September of that year. This 
pilot study was designed to assess the feasibility of implementing the Photovoice 
program at Riverside. The Photovoice program and study protocol were well received by 
participants and we established a very strong partnership with the Clubhouse staff and 
had their support for the entire pilot study.  
 
6. Subjects 
 
The inclusion criteria for the study refer to individuals who are: 1)18 or older; 2) meet the 
State of MA definition of SMI based on an Axis I or II DSM-IV diagnosis and 
impairment in at least one major area of functioning for at least 12 months; 3) currently 
receiving services from Riverside; 4) willing to give written informed consent to 
participate in the study; and 5) conversant in English. Exclusion criteria 
include: 1) prior exposure to Photovoice; and 2) history or existing diagnosis of 
intellectual disability, based on chart records. We plan to recruit approximately 50% of 
the study sample among individuals with primary diagnosis of schizophrenia-spectrum 
(schizophrenia, schizoaffective, schizophreniform) disorder. We anticipate that most of 
the remaining study participants will have a primary diagnosis of a major mood disorder, 
and that a small proportion will have other disorders. This sample profile is reflective of 
the individuals served at Riverside clubhouses and by CBFS teams, since both programs 
are funded by the MA DMH and all recipients of services meet criteria for SMI as 
established by the MA DMH. 
 

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A total of 192 participants or 96 participants per group (Photovoice as the experimental 
condition and Services as Usual enhanced with a 60-minute peer-led group discussion as 
the control condition) will be recruited and randomized over a period of 36 months across 
the three clubhouses of Riverside Community Care where the intervention will take 
place. We plan to have randomization cohorts of 16 individuals per delivery of the 
Photovoice program at each of Riverside’s three clubhouses (Needham, Norwood, and 
Wakefield). Given the projected sample size of 192 participants, we will have 12 
randomization cohorts – 4 at each clubhouse implemented at 6-month intervals. 
Anticipating that not all individuals who sign the consent form complete the baseline 
interview and are therefore not randomized to a study group, we will enroll up to n=222 
individuals in order to achieve our target sample size.  
 
We have been implementing the study according to this plan and have had 4 waves of 
recruitment at Horizon House, 5 at Neponset River House, and 3 at Eliot House for a total 
of 12 waves of recruitment. However, recruitment has been slowing down and we are 
unable to enroll approximately16 individuals per wave as was planned. We had 
previously discussed a backup plan with Riverside leadership to extend the study to their 
clubhouse in Hopedale in the event that recruitment slowed down and we were not able 
to meet target recruitment. At this time, we would like to implement this plan. We have 
approval from the sponsor, NIMH, to proceed with this plan.The procedures at Hopedale 
will remain the same as they have been at the other clubhouses.  
 
We worked with Riverside senior management to establish the non-overlapping number 
of clients with SMI served in the catchment areas for the three clubhouses where the 
Photovoice program will be offered. About 1,300 individuals with SMI are served on an 
annual basis in the three catchment areas (Norwood, Needham and Wakefield) where the 
study will be conducted; of them, approximately 900 individuals are served by the 
clubhouses and the CBFS teams, all of whom meet MA criteria for SMI, with 
approximately 50% diagnosed with a schizophrenia-spectrum disorder. Riverside treats 
approximately 200 new clients with SMI per year, with most being served at the 
clubhouses or by CBFS teams. Thus, there are an ample number of eligible participants 
for the study. Furthermore, in our pilot feasibility study at the Norwood clubhouse, 8 
(53%) out of the 15 participants had a diagnosis of schizophrenia-spectrum disorder. 
 
Potentially eligible consumers will be identified by informing staff and members of the 
three targeted clubhouses and the CBFS teams about the study and eligibility criteria for 
participating in it. Project staff will make presentations to Riverside clinicians and other 
staff as well as to clients served at the corresponding clubhouses and CBFS teams to 
inform them about the study. Referrals of potentially eligible participants to the study will 
be made by Riverside staff using a “Consent to Contact” form which will prevent project 
staff from having Protected Health Information prior to ascertaining the individuals’ 
interest in study participation. Clients attending study presentations may also complete 
the Consent to Contact form at the end of the presentation. Along with the Consent to 
Contact form we will ask potential participants to sign the Riverside Release of 
Information form to obtain authorization for research staff to check chart diagnoses in 
order to confirm diagnostic eligibility.   

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When a referral using the Consent to Contact form is made to the project, the potential 
participant will be contacted by phone or in person by the Project Coordinator to further 
determine their understanding of the research and their interest in participation. Prior to 
the phone call the Project Coordinator will obtain information about the person’s 
diagnoses, including history or diagnosis of intellectual disability.  In case an interested 
individual has a diagnosis associated with intellectual disability, the Project Coordinator 
will contact this person and inform him/her that they don’t meet the study eligibility 
criteria based on information in their chart record. The Project Coordinator will explain 
the following to interested individuals who meet diagnostic eligibility: the details of the 
study, random assignment to two conditions, the interventions, and the research 
interviews as well as provisions for maintaining privacy and confidentiality. The Project 
Coordinator will screen for inclusion and exclusion criteria during this initial contact. 
Thus, all screening will be completed prior to administration of informed consent without 
implications for participants’ compensation; hence, no references to pre-consent 
screening are included in the ICF. If the person remains interested in the study, the 
Project Coordinator will set up an appointment for the informed consent. If a person has a 
legal guardian, the guardian will be involved in the consent process. For those individuals 
who do not have a guardian, the Project Coordinator will explain the study in person and 
ask a brief set of questions to determine whether the individual has understood the nature 
of the research project, including the assessments and treatment approaches. We will 
provide corrective information as needed if the individual is unable to answer the quiz 
questions during the consent process, followed by additional checking to assure a 
participant’s full and knowing consent. Potential participants who continue to express 
interest in the study and are able to demonstrate their understanding of the study by 
correctly answering these questions will then be asked to sign the informed consent form. 
Individuals who meet the eligibility criteria and who are able to provide full and knowing 
consent will proceed to scheduling of the baseline assessment with the Clinical 
Interviewer.  Upon completion of the baseline assessment, participants will be randomly 
assigned to either the experimental (Photovoice) or the enhanced Services as Usual 
(SAU) conditions. The Project Coordinator will contact each participant and explain their 
randomization condition. Participants randomized to participate in the Photovoice 
program will be informed about the date of their first Photovoice session and participants 
randomized to the control condition will be informed about the date of the 60-minute 
peer-led group discussion session about understanding and coping with prejudice and 
discrimination. The Clinical Interviewer will be blind to participants’ randomization. 
 
If an interested potential participant has a legal guardian, the guardian will be contacted 
by project staff and the consent process will take place with the guardian. This could 
occur by phone or in person. The guardian will be informed of the project details and will 
consent on behalf of the potential participant. We will proceed through an assent process 
with the participant where they are informed of the project details, informed of their 
guardian’s involvement and consent and asked to agree to project participation and sign 
an assent form. 
 
7. 
Research Methods and Procedures    

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We will conduct a randomized controlled trial (RCT) comparing the 10-week peer-led 
Photovoice program to services as usual (SAU) enhanced with a 60-minute peer-led 
group discussion session. The RCT will be conducted at a large publicly funded 
community mental health agency (Riverside Community Care, Inc.). The 10-session, 
peer-led Photovoice program, designed to empower individuals with SMI to confront 
public prejudice and discrimination and reduce personal stigma (self-stigma and 
perceived stigma), was developed and pilot tested at our Center, with primary 
contributions from staff with a lived experience of mental illness (see Photovoice 
Manuals and a Summary at Glance Table submitted as an attachment in this application.) 
The control SAU condition will be enhanced with a 60-minute peer-led manualized 
educational group session (Leaders’ Guidelines and Handout for Participants are 
attached). The content of this session has been adapted from the Recovery Strategies 
module of the Illness Management and Recovery (IMR) program for the purposes of this 
project. It will provide participants with information about the nature of stigma and the 
laws in the U.S. that protect people with disabilities from discrimination. Participants will 
be engaged in a discussion about their use of different strategies for proactive coping with 
psychiatric stigma. This session will be co-led by the same peers who will be delivering 
the Photovoice program to the experimental group at relevant wave and study sites. An 
optional educational handout will be provided to participants who wish to have material 
in writing.  In addition, participants randomized to the enhanced Services as Usual 
control condition will be invited to join a Photovoice group once they complete the final 
6-month follow-up assessment. 
 
A total of 192 individuals with SMI (50% with schizophrenia spectrum disorders) will be 
randomized to either the Photovoice program (plus usual services) or enhanced SAU. 
Participants will be assessed by the Clinical Interviewer at baseline, post-treatment, 3-
month and 6-month follow-ups on a range of primary and secondary outcomes related to 
personal stigma, coping, and functioning. Primary analyses will test the hypotheses that 
the Photovoice program will lead to significantly greater reductions in self-stigma and 
perceived stigma, greater improvements in proactive coping with psychiatric prejudice 
and discrimination, and greater improvements in community functioning and integration 
than SAU. Secondary analyses will evaluate whether the Photovoice program leads to 
greater gains than SAU in psychological adjustment, including wellbeing, personal 
growth and recovery. 
 
Outcome measures include demographics, diagnosis, symptoms, levels of self-stigma 
and perceived stigma, coping with stigma, psychosocial functioning, community 
integration, psychological wellbeing, and recovery. All assessment interviews will be 
conducted in individual, face-to-face meetings with study participants in private offices at 
the research sites. Psychiatric diagnoses will be determined at baseline with the MINI. 
Eligibility determination will be supplemented by chart review of psychiatric diagnoses 
and presence of intellectual disability. All other primary (personal stigma, community 
functioning and integration) and secondary (psychological wellbeing, personal growth 
and recovery) outcome measures will be evaluated at baseline, post-treatment, 3- 

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month and 6-month post-treatment follow-ups by the Clinical Interviewer who will be 
blind to the participant randomization status. The Clinical Interviewer will be trained in 
methods for eliciting self-report information, and standard interviewing procedures. In 
order to ensure high reliability and prevent rater drift of the Clinical Interviewer, we will 
audiotape all assessments and we will randomly select 10-15% for reliability checks. We 
will collect all relevant service utilization information from Riverside using their 
administrative databases after participants have completed the 6-month follow-up 
assessment. Eligible individuals who consent to participate at the study will complete a 
second Riverside Release of Information (ROI) form to authorize release of service 
utilization data since the first ROI will authorize only release of their chart diagnoses to 
determine eligibility. 
 
We will be using the following measures to assess these outcomes: 
 
Mini Neuropsychiatric Interview (MINI) - is a widely used 15-minute structured 
interview assessing the presence of 17 DSM-IV Axis I disorders with good concordance 
with the SCID and the CIDI and with acceptable test-retest reliability. 
 
Brief Psychiatric Rating Scale - is a 24-item scale that rates severity of a variety of 
psychiatric psychotic symptoms, positive and negative symptoms on a 7-point scale of 1 
(absent) to 7 (severe). 
 
Approaches to Coping with Stigma - (Link et al., 1989) – is a 27-item, 4-point scale 
(strongly disagree to strongly agree) measuring strategies to cope with stigma: secrecy, 
withdrawal, distancing, educating others, and challenging others. The total score of the 
first three subscales will represent the index for Avoidant Coping and the total score of 
the last two subscales – the index for Proactive Coping with Stigma. Internal consistency 
for subscales range: .63-.84. 
 
Internalized Stigma of Mental Illness Scale - a 29-item, 4-point scale (strongly 
disagree to strongly agree) assesses behaviors, thoughts and feelings that are self-
stigmatizing and includes alienation, stereotype endorsement, discriminatory experiences, 
social withdrawal, and stigma resistance subscales. Internal consistency is .9 and test-
retest reliability is .92. 
 
The Stigma Scale (King et al, 2007) - is a 28 item, 5 point scale (strongly disagree to 
strongly agree) measuring experienced and anticipated stigma. Internal consistency 
ranges from .85-.87 and test-retest reliability from .4 to .7. 
 
Heinrich’s Quality of Life Scale-Client Version - Is a 21 item semi-structured 
interview based rating of individual’s psycho-social functioning and satisfaction with 
various life domains. 
 
Temple University Community Participation Scale - is a 26 item instrument 
measuring frequency of participation and importance of various community activities 
(e.g., movies, library). Test-retest reliability is .7 and internal consistency is .9. 

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Scales of Psychological Well-Being - is a 54-item measure rating wellbeing (from 
strongly disagree to strongly agree) including subscales of mastery, personal growth, 
purpose in life, self-acceptance, autonomy and positive relations with others. Internal 
consistency is .94. It has been successfully used with individuals with SMI. 
 
Maryland Assessment of Recovery - is a 25-item scale that assesses a person’s sense of 
recovery from mental illness across a variety of dimensions. Internal consistency is.95 
and test-retest reliability is .89). 
 
Personal Growth and Recovery Scale - (BU CPR, 2009) - is a 16-item, 4 point scale 
(strongly disagree to strongly agree) developed for previous Photovoice study. Items tap 
aspects of person’s psychosocial functioning and recovery. Internal consistency is 0.94 
and retest reliability is .79. 
 
Photovoice Program Fidelity Scale - the Photovoice Fidelity Scale was developed and 
used in our pilot RCT study (Russinova et al., 2014). The scale includes content fidelity 
items specific to each of the 10 Photovoice sessions and 13 process fidelity items which 
are specific to the Photovoice program as a whole. All items are measured on a 4-point 
scale from 1, “strongly disagree” to 4, “strongly agree”.  All Photovoice sessions will be 
audiotaped and fidelity will be assessed based on review of all audio-recorded sessions. 
 
We will use a Demographic Questionnaire developed by the Boston University Center 
for Psychiatric Rehabilitation and previously used in multiple research studies. Questions 
inquire about the person’s demographic characteristics, such as age, race, gender, 
education, employment status, housing situation, and basic clinical characteristics, such 
as perceived physical health and use of different mental health services in the past 3 
months. We are using an abbreviated version of this questionnaire at post-treatment and 
follow-up assessments to capture information only on time varying variables included in 
the questionnaire. 
 
We will employ several strategies to retain participants in both the VEP sessions and in 
study assessments. First, we will use information from the Locator Form they will 
complete at baseline. We may also gather contact information from the participant’s 
Riverside treatment team. Participants in the experimental arm will receive regular calls 
from the Photovoice peer leaders to encourage participation in classes. We have 
established a protocol for the peer leaders to call all participants the day before each 
Photovoice class. If they do not reach the participant, they leave a voice message. For 
participants who have expressed a preference for email reminders, peer leaders will send 
an email message the day before each class. If participants miss a class they will be to 
encouraged to continue their involvement. Calls from the Photovoice peer co-leaders will 
allow an opportunity to discuss with participants any barriers to participation, such as 
transportation issues and to take steps to remedy those barriers.  
 
We will implement the following protocol for contacting participants in both the 
experimental and control condition about upcoming assessments. The Clinical 

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Interviewer will initiate a phone call with each study participant approximately two 
weeks before the due date of each assessment and will schedule an appointment to 
administer the assessment. If the participant is not available, the Clinical Interviewer will 
leave a message asking the participant to call back to schedule an assessment. If the 
participant does not respond within two days, the Clinical Interviewer will make another 
call using the same procedural approach. If the participant still does not respond within 
two days, the Clinical Interviewer will send an email if such is available and will follow 
up depending on the participant’s response. At the same time, the Clinical Interviewer 
will contact Riverside staff involved in the study to inquire about the participant’s 
whereabouts in case information about changes in the participant’s programmatic status 
(i.e., hospitalization, expulsion, etc.) has not been already provided to the research staff.  
Participants agreement to have Riverside staff provide information about their thereabout 
will sought as part of the initial consenting for study participation.  In addition, we will 
send a letter to the participant’s known address with information about the relevant study 
assessment point. If the participant does not respond to the email and letter and there are 
no changes in their programmatic status, the Clinical Interviewer will call the contacts 
identified by the study participant on the Locator Form they completed at the baseline 
assessment and will ask about ways to contact the participant either directly via new 
phone number or email or indirectly with the help of the contact person. If all these 
efforts to reach the participant are not successful, they will be repeated for the next 
assessment point. 
 
The data will be managed by project staff, using the same procedures we have used for 
longitudinal studies and randomized trials conducted by the Center. We will design 
systems for tracking specifically for this project using Microsoft Access. 
We have used Microsoft Access for data management, to design data entry forms, to 
perform direct data entry, to monitor recruitment efforts and participant retention, and to 
track the timeliness of the scheduled assessments. We will develop and test these systems 
and will train the Clinical Interviewer in the use of the direct data entry procedures. The 
Clinical Interviewer will perform data entry in the field on a laptop using the data entry 
forms developed specifically for this study. The laptop used for data collection will not 
store any data in its hard drive. The data will be collected using a software application 
(REDCap) and stored on a secure network as described below. 
 
Study data will be collected using the REDCap data collection system, a software tool 
developed at Vanderbilt University and made available through the Clinical and 
Translational Science Awards network (CTSAs).  To help protect and secure the data 
stored in REDCap’s database, the software application employs several methods to 
protect against malicious users who may attempt to identify and exploit any security 
vulnerabilities in the system. Access to the REDCap data entry website will be based on 
permissions granted by username and password which will be managed by the Boston 
University Medical Campus Office of Information Technology.  Only authorized study 
members will be able to enter or view data.  The login information (username) of the 
person submitting the information, the date and time submitted, and other navigational 
information will be automatically obtained and stored in the database.   
 

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Information posted on forms will be electronically encrypted using secure socket layering 
(SSL) encryption technology so that only the intended recipient can decode the data.  
Data will reside on a secure, password protected server at Boston University Medical 
Center (BUMC) to which only designated individuals have access, thus providing a 
secure environment for all project data.  The database will be automatically backed up on 
a nightly basis.  Files stored on BUMC servers will be protected by electronic ‘firewalls’ 
that restrict access to designated users.  Restrictions and permissions to update the 
database will be controlled through the REDCap web application. Therefore, the data will 
not reside on the hard drive of the laptop used to access REDCap.  
 
Once the data is downloaded onto the BU Network from the BUMC server it will reside 
in a server specific to the Center for Psychiatric Rehabilitation and within that in a project 
specific folder that only project staff have access to. This server while not HIPAA 
compliant has the layers of protection described above to restrict access. We have been 
storing research data on this server for several years and have not encountered any 
breaches in security of data. All project staff with access to the server have training in the 
protection of human subjects and specifically oriented to maintaining confidentiality of 
PHI. Access to the project specific folders is regularly monitored to ensure only current 
project staff have access to them.  
 
 In addition, a Microsoft Access relational database will be created to facilitate close 
monitoring of potentially interested participants, enrolled participants, recruitment efforts 
across sites, the status of completed and pending assessments, and adverse events (should 
they occur). Microsoft Access queries can be used to monitor the proportion and 
timeliness of completed assessments, provide “ticklers” for pending and upcoming 
assessments, and allow the PI to readily aggregate information about recruitment efforts 
by site. The data entered in REDCap will be downloaded as SAS datasets for analyses. A 
test of the procedures to export Access files and import them into SAS will occur when 
half the data have been entered.  
 
Based on the NIMH reviewers’ comments we will also consider conducting a small 
qualitative sub-study to examine the range of positive changes participants in the 
Photovoice program may experience beyond those measured with our quantitative scales. 
We have proposed to conduct 60-minute focus groups with interested Photovoice 
participants in each of the 12 waves of the study after the corresponding 6-month follow-
up assessments have been completed. We will submit an amendment to this protocol and 
will develop a separate informed consent form for Photovoice participants invited to 
contribute to these groups at a later point when these plans are finalized. 
 
Start Date and Duration of the Study: This study is slated to be completed in four years 
and the recruitment will take place in waves with 16 participants randomized at a time. 
Each participant will be in the study for about 34 weeks; this includes 10 weeks of the 
intervention period through the follow-up at six months.  
 
 
8.  
Assessment of Risk to Subjects 

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We believe that there are minimal risks resulting from participation in this study. The 
study design does not require that the individual’s current mental health services be 
disrupted or altered in any way. Furthermore, anecdotal information from piloting the 
photovoice program suggests that it is a meaningful and engaging intervention and one 
that resonates well with participants. We have had no indications of distress or concern on 
the part of participants who participated in the several pilot sessions of the Photovoice. 
However, should an individual become distressed during a session, there are several steps 
we will take to minimize and address problems. First, all sessions are being conducted by 
highly skilled and experienced peer specialists, including one co-leader who is a certified 
peer specialist. These individuals have been trained and supervised at the Boston 
University Center for Psychiatric Rehabilitation to deliver similar interventions so that 
they will be experienced in detecting signs of distress. Peer specialists from Riverside who 
will be trained as Photovoice co-leaders will receive additional training about detecting 
and addressing signs of distress during the delivery of the Photovoice sessions. All 
Photovoice peer co-leaders will receive ongoing supervision during the course of the 
proposed research as well to insure that they are handling any issues that arise during the 
study with skill and sensitivity. If a participant becomes distressed during a class, one of 
the co-leaders will attend to the person to determine if their distress can be alleviated 
within the class. If that is not possible, they will be brought out of the group setting and 
attended to privately. If the co-leader is unable to address the person’s distress, clubhouse 
staff will be notified to intervene, and if necessary, the individual’s clinician or case 
worker will be contacted for further assistance. 
 
Similar procedures will be followed during the assessments. We have pilot tested several 
of the measures and have had no indications of distress during administration of these 
measures. However, should an individual become distressed during an assessment, the 
Clinical Interviewer will be instructed to attend to the person’s distress by stopping the 
interview and inquiring about the source of the person’s discomfort. The Clinical 
Interviewer will offer to have the individual take a break from the interview, discuss their 
concerns, and allay any concerns about the interview itself. We will also remind subjects 
during the interview that their participation is totally voluntary and that they can refuse to 
answer single questions, or to stop the interview if desired. Participants will be reminded 
that the information collected is confidential and will not be shared with Riverside staff. If 
the Clinical Interviewer is not successful in addressing the person’s distress, he or she will 
contact Riverside staff using a written protocol we will establish with them in advance. 
That may include contacting the person’s clinician or case worker depending on the 
procedures desired by Riverside senior administration. The Clinical Interviewer will 
receive training and supervision about how to identify and respond to distress among 
study participants and how to proceed using these guidelines. We have used such 
procedures in prior research studies with success. 
 
We will take several steps to insure that staff follows procedures to maintain privacy and 
confidentiality. First, all new staff will be required to be oriented and trained in procedures 
to maintain confidentiality of information, including written and electronic materials. Staff 
is required to sign a Confidentiality Contract, which describes the serious nature of 
maintaining confidentiality and enumerates procedures for maintaining it. All project staff 

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will be required to take and pass the CITI training course on the protection of human 
subjects. In addition, project staff will be instructed about PHI, the need to identify 
individuals by arbitrary identification numbers, the need to file materials with names or 
key lists separate from research materials, electronic privacy, the need for non-identifiable 
correspondence materials from the Center, removing or blacking out participant names 
from any forms; sorting all data in locked file cabinets; securing all computers that store 
data; and destroying audiotapes used for interviewer reliability checks and fidelity ratings 
at the end of the project. 
 
Study participants will be informed that information obtained through research interviews 
is confidential. Data will be identified by a unique identification number rather than by the 
participant’s name or any other PHI. Research data will be stored in locked cabinets and 
are accessible only by research staff. Riverside staff will assist with study recruitment, but 
at no time will have research materials in their possession. All potentially sensitive 
materials will be in the possession of the project staff only. Computers that store research 
data are in secure offices at the Boston University Center for Psychiatric Rehabilitation. 
Computer files with sensitive data such as names are protected by passwords. The peer co-
leaders of the Photovoice program are highly experienced and well trained in issues about 
sensitive information and the need to maintain the confidentiality of any discussions that 
arise during the Photovoice groups. Any distress that may be expressed during the 
Photovoice classes will be dealt with sensitively by the co-leaders. If appropriate, peer co-
leaders may use any distressing experiences to further the understanding, knowledge and 
resources of other participants in the group to cope with stigma. In our experiences with 
the pilot studies of the Photovoice program, very minimal distress was experienced and it 
was generally related not to the intervention, but rather to participants’ prior experiences 
of prejudice and discrimination. 
 
Photovoice participants are also trained in the ethics of taking pictures - including 
obtaining permission prior to photographing individuals, and respecting the privacy and 
confidentiality of others. In addition, all photographs are screened by project staff for 
appropriateness prior to being shared with the rest of the class. With these measures in 
place we do not anticipate that pictures taken by participants would raise any safety/ 
mandatory reporting issues. Should such a situation arise we will work with Riverside 
clinical staff to report to appropriate authorities. Participants will be informed of the limits 
to confidentiality and the mandatory abuse reporting requirements for research staff 
through the informed consent form.  
 
9. 
Procedures for Monitoring Subjects’ Well-Being 
 
 
The Clinical Interviewer who will be collecting data will be trained prior to data collection 
to identify potential signs of distress in the participants and how to address situations 
when a participant indicates any thoughts about ending his/her life and/or about hurting 
oneself.  In the event that distress in a participant during an interview appears to present a 
risk of suicide, the interviewer will respond by following procedures we have developed 
and implemented in previous research studies at the Center for Psychiatric Rehabilitation. 
Statements made during interviews by participants about thoughts of death, hurting 

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oneself, or ending one’s life will be followed up with the following questions by the 
interviewer to determine severity of suicide risk, based on item 4 of the Brief Psychiatric 
Rating Scale (BPRS):  
 
 
“In the past two weeks, have you thought about harming or killing yourself? 
 
• What about just feeling tired of life? 
 
• Or that you’d be better off dead? 
 
[if patient reports suicidal ideation, ask the following]: 
 
• How often in the past two weeks have you thought about [use the patient’s description] 
 
• Did you (do you) have a specific plan?” 
 
 
If the participant’s score on this item is 2 or above, indicating mild or higher suicidal 
ideation, the interviewer will immediately contact designated Riverside clinical staff to 
provide appropriate care, without leaving the participant alone. 
 
 
 Photovoice peer leaders who encounter any similar reports of suicidal thoughts or 
intentions before, during, or after a Photovoice class will be taught how to follow up the 
statement by asking similar questions to those described above for the interviewer (in 
private, if the statement was made during a class), and will follow up by contacting 
immediately Riverside clinical staff using the same procedures described above for 
interviewers if significant suicide risk is identified in a participant. We will work with 
Riverside staff to establish a protocol of which clinical staff should be contacted to 
prevent any harm if significant suicide risk is identified in a participant. Study participants 
will be informed as part of the consenting process and at the beginning of each assessment 
that if they were to share any risk of harm to themselves or others, such information will 
not be kept confidential and clinical staff at the agency will be informed and will follow 
the procedures of the agency to ensure participants’ safety. 
 
10. 
Care and Treatment Statement 
 
 
 Participation in the study will not result in any change to the services outside of the study 
that participants are already receiving or plan to enroll in. 
 
11. 
Informed Consent (See Part F) 
 
Consent will be obtained in person in an individual meeting with the Project Coordinator. 
The details of the study contained in the informed consent form will be reviewed section 
by section. After each section of the consent, the Project Coordinator will ask if potential 
participants have any questions about that section of the consent form.  Individuals will 
be requested to complete the quiz (see attached) to determine their capacity to consent 
before proceeding with obtaining their signature on the consent.  The quiz responses will 
be reviewed discreetly to ensure that each individual gets 8 out of the 10 items correct. If 
an individual does not get the required number of answers correct, the Project 
Coordinator will review the incorrect answers with the individual and make an individual 
determination of the individuals’ capacity to understand the details of the study and to 
give knowing consent. If the person is found to be capable of giving consent, the 
potential participant will be asked to sign the consent form.  If the potential participant 

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does not appear to have the capacity to give consent, he or she will be advised that they 
cannot participate in the study. All participants will be provided with a copy of the 
consent for their records. In addition participants are informed that they are free to 
withdraw their consent at any time during the course of the study should they change 
their mind. 
 
 
 
 If a person has a legal guardian, the guardian will be involved in the consent process.  
 
The guardian will be contacted by the Project Coordinator and the consent process will 
take place with the guardian. This could occur by phone or in person. The guardian will 
be informed of the project details and will consent on behalf of the potential participant. 
We will proceed through an assent process with the participant where they are informed 
of the project details, informed of their guardian’s involvement and consent and asked to 
agree to project participation and sign an assent form. 
 
12. 
Benefits 
 
 
Our pilot study of the Photovoice program has shown evidence of reduced self-stigma, 
increased ability to cope proactively with stigma, improvements in the level of personal 
recovery. We anticipate participants in this project may experience these benefits as well. 
The Photovoice program is a promising mental health intervention that could provide an 
engaging way of helping individuals with serious mental illnesses to deal with psychiatric 
stigma and increase their community integration and psychosocial functioning. 
 
 
 
We consider that the potential benefits of this study greatly outweigh any minimal risks 
of discomfort.  
 
13. 
Remuneration, Costs and Reimbursements 
 
 
There will be no cost to participants for taking part in this study, the intervention 
including all the materials will be provided free of cost. Participants will be paid $50 for 
the baseline assessment, to account for the extra time necessary for the MINI, and for the 
6-month assessment to encourage completion of the last evaluation. Payment for the post-
treatment and 3-month follow-up assessment will be $40, as we anticipate that each 
assessment will last approximately two-and-a-half hours. Therefore, a participant who 
completes all four assessments will receive a total of $180 over the period of their 
participation in the study.  
 
 
14. 
 Explain why the research requires the participation of persons with mental illness. 
 
 
This research requires the participation of persons with mental illness as it studies a new 
approach to addressing issues related to stigma among persons with mental illness and 
enhancing the ability of persons with mental illness to overcome the impact of stigma on 
their lives. The specific aim of this project is to evaluate the effectiveness of this 
approach that could improve quality of life of persons with mental illness. 
 
15. 
Safeguards for Confidentiality 
 

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The Center for Psychiatric Rehabilitation has developed extensive procedures for the 
protection of privacy and confidentiality of all research data collected. First, we will use 
sequential numeric identifiers on all data collected and will not use the person’s name or 
other sensitive data on the research data. Only Center for Psychiatric Rehabilitation 
research staff on this project will have access to the identifier and the name.  All research 
materials will be stored at the Center for Psychiatric Rehabilitation in locked file cabinets 
and electronic data files. Documents containing data will be kept until all analyses are 
completed - likely until the end of 2019 – and will be shredded afterwards. Consent forms 
will be kept for seven years and shredded afterwards. No individual participating in this 
study will be identified by name in any report or description of study findings. The 
photographs taken by participants in the intervention will be the property of the 
participants and will not be disseminated without their permission to do so. 
 
 
We will take several steps to insure that staff follows procedures to maintain privacy and 
confidentiality. First, all new staff will be required to be oriented and trained in 
procedures to maintain confidentiality of information, including written and electronic 
materials. Staff is required to sign a Confidentiality Contract, which describes the serious 
nature of maintaining confidentiality and enumerates procedures for maintaining it. All 
project staff will be required to take and pass the CITI training course on the protection of 
human subjects. In addition, project staff will be instructed about PHI, the need to 
identify individuals by arbitrary identification numbers, the need to file materials with 
names or key lists separate from research materials, electronic privacy, the need for non-
identifiable correspondence materials from the Center, removing or blacking out 
participant names from any forms; sorting all data in locked file cabinets; securing all 
computers that store data; and destroying audiotapes used for interviewer reliability 
checks and fidelity ratings at the end of the project. 
 
16. 
Final Product(s) 
 
 
Final results will be reported in aggregate form only.  Results may be prepared for 
publication in peer reviewed professional journals in mental health and rehabilitation, and 
used as preliminary data for future development of the intervention.   
 
17. 
Financial Summary 
  
 
The project is being funded by the National Institute of Mental Health - Grant Proposal 
MH102230-01A1. 
 
18. 
Compensation for Injuries 
 
 
We do not anticipate any injuries related to participation in the study and do not plan on 
any compensation for injury. There may be a minimal risk for physical injuries while 
individuals are taking pictures in the community. The Informed Consent Form informs 
participants that if this occurs, the cost of required medical services will have to be 
covered by their insurance or by them personally. 

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19. 
Insurance 
 
 
There are no entitlements or insurance for the subject that will be purchased or invoked 
for this project.  There is no other insurance purchased by Boston University for the 
subjects. 
 
20. 
Use of DMH Resources 
 
 
No DMH resources will be used for this study.   
 
21. 
Other IRBs Involved 
 
 
Boston University Charles River Campus (CRC) IRB. 
 
22. 
Adverse Events 
 
 
An adverse event for this study is consonant with the guidelines set forth by the MA 
DMH.  Reporting guidelines will be followed in the event of an adverse event. 
 
 
It is highly unlikely that we will experience a serious, unexpected adverse events related 
to study participation in the Photovoice intervention. Riverside staff will be asked to 
report any unexpected serious adverse event among study participants to the PI within 3 
days of becoming aware of the occurrence of any such event. The Project Coordinator 
will be required to report such events to the PI within 24 hours of becoming aware of 
their occurrence. The PI will follow the requirements of the Data Safety and Monitoring 
Board and the MA DMH IRB (the IRB of record for the study): a) in case of a serious 
adverse event – verbal notification as soon as possible and in writing by the next business 
day following the event; and b) non-serious adverse event will be monitored, recorded, 
and reported to the IRB Chair every 4 months. The PI will notify NIMH within 7 days of 
becoming aware of the occurrence of a study-related serious adverse event and will report 
non-serious adverse events in the corresponding progress reports to NIMH.  
 
 
Continuous and close monitoring of study participants’ safety by the PI will occur in 
conjunction with the Dartmouth College Data Safety Monitoring Board (DSMB). The 
current research project is a Phase II trial, involves a low risk intervention, is not 
conducted with a vulnerable population, and is not blinded to participant or treatment 
provider. However, given that the research is being conducted in three locations within 
one agency, a Data Safety and Monitoring Board (DSMB) will be constituted to provide 
additional human subjects’ oversight. Two Investigators on this project are faculty at 
Dartmouth Medical School: Drs. Mueser and Xie (statistician). Through this affiliation 
with Dartmouth, we plan to use their standing DSMB comprised of three psychiatrists 
and a psychologist (see attached bio sketches of the Dartmouth Medical School DSMB 
members). Dr. Mueser has used the Dartmouth DSMB for multiple prior RCTs, 
supported by NIMH, evaluating the impact of psychosocial interventions on persons with 
SMI. The DSMB will establish a risk level for the study, and based on that assessment 

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will determine the frequency of DSMB meetings and review of pertinent data. The 
DSMB Chair (Dr. Hegel) will be notified by the PI of serious adverse events that are 
study related using the protocol specified in the next paragraph. An ongoing record of all 
adverse events will be kept by the PI for use and review of the DSMB at the meetings. 
Minutes will be kept of DSMB meetings, including any discussion or decisions made 
about adverse events, and including those that could affect the conduct of the study. The 
DSMB will report back to the PI within one business day any implications for patient 
safety that arise from discussions during the scheduled DSMB meetings. 
 
23. 
Required Attachments 
 
Resume of the Principal Investigator 
Certificate of Completion of the Human Subjects Training Course  
Unaffiliated Investigator Agreement 
Recruitment Flyer and  
Consent to Contact Form  
Informed Consent Form  
Copies of the research instruments 
Competency quiz 
 
24. 
Attachments that are appropriate, when applicable: 
 
(a) 
Approval Form(s) from other IRBs that have reviewed this project. 
(b) 
Copies of non-standardized questionnaires, instruments, tests, etc. 
(c) 
Copies of posters, flyers, letters, etc. 
(d) 
Scripts of intended communications by telephone or interview. 
(e) 
External research protocols (usually, only five (5) copies are required of the 
technical drug research protocols - check with the CORRC before submitting 
materials).