Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Phase: NA
Conditions: Sexual Abuse
Sponsor: Yale University

Date: May 18, 2021 
 
 
 
Title: Peer Online Motivational Interviewing and Affirmative Care for Sexual and Gender Minority 
Male Sexual Abuse Survivors: A Randomized Clinical Trial 
 
 
 
ClinicalTrials.gov ID: NCT03794986 
 
 
 
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project 
Program Award (AD-2018C1-110989). All statements in this report, including its findings and 
conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-
Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.  
 
 

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HRP-503E– Protocol for Social or Behavioral Science or Educational Research
(2017-1)
Protocol Title: Peer Online Motivational Interviewing for Sexual and Gender Minority Male 
           Survivors
Principal Investigator: Joan M. Cook, Ph.D.
Version Date: 11.20.2018 (Version 1)
(If applicable) Clinicaltrials.gov Registration #: NCT03794986
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SECTION I: GENERAL INFORMATION
1.
Probable Duration of Project: State the expected duration of the project, including all follow-up and 
data analysis activities.  
The active phase of the study will take place over three years (i.e., no data collection past year 3). However, 
we anticipate data analysis will occur for two additional years making the entire duration of the study 5 
years.
2.
Study location: State where the study will take place and in what setting. 
The study will include peer leaders from two non-profit organizations, MaleSurvivor and Men Healing, as 
well as emotionally distressed sexual and gender minority male survivors who have not recently engaged in 
mental health care. The study will largely take place in online discussion groups and via 
telephone/teleconferencing calls.  
This is the second Patient-Centered Outcomes Research Institute (PCORI)-related grant that we have had in 
partnership with MaleSurvivor, a non-profit trauma survivor organization that provides resources to male 
abuse survivors and their loved ones worldwide. Their website currently sees hundreds of thousands of 
visits annually from persons all over the world, and their social media platforms reach millions every month 
with news and messages of hope, healing, and support. MaleSurvivor has over 5,250 followers on 
Facebook, and over 11,000 followers on Twitter. In addition, MaleSurvivor distributes their newsletter to 
over 12,000 unique, active email addresses. They also currently have 39 active online discussion forums 
that reach people worldwide.
If international, complete and submit International checklist (http://your.yale.edu/policies-
procedures/forms/450-ch-1-international-research-checklist) Note: If your research involves interactions 
with any embargoed countries you should contact the Director of Corporate Contracts and Export Control 
Licensing (Donald.Deyo@yale.edu or call 203.785.3817) for guidance on how to proceed.   
3.
Help us categorize your research. Are you using any of the following?
☐ Class Project
☐ Participant Observation
☒ Interviews
 Surveys
☐ Focus groups (study is not anonymous)
☐ Research in K-12 schools (submit a School Agreement form for the study)
☐ Deception (submit a Debriefing sheet)
 Audiotaping, videotaping or photography of individuals (study is not anonymous)
☐ Public viewing of videotapes or photographs 
☐ Yale Psychology Pool (study does not qualify for exemption)
☐ International research sites (attach the International Checklist)
 Online (web-based) activities
☒ Social networks
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SECTION IV: RESEARCH PLAN
1.
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
This study builds on the  findings from our Eugene Washington PCORI Engagement Award, 
entitled, “Facilitating Male Trauma Survivors’ Meaningful Involvement in Health Research.” Together with 
our non-profit community partner, MaleSurvivor, we tailored an evidence-based psychological treatment, 
motivational interviewing (MI; Miller & Rollnick, 2013) with trauma-informed, sexual and gender minority 
(SGM) affirmative care in order to encourage formal engagement in mental health treatment and reduce 
health disparities for SGM male sexual abuse survivors. 
We then applied for and received a comparative effectiveness trial funded through PCORI (AD-
2018C1-11098) entitled, “Peer Online Motivational Interviewing for Sexual and Gender Minority Male 
Survivors.” The first specific aim is to train peer leaders to competently deliver MI in both its original and 
tailored versions. The second specific aim is to conduct a randomized controlled trial (n=356) to determine 
the comparative effectiveness of MI versus MI with trauma-informed SGM-affirmative care delivered by 
peers in online male survivor discussion groups. Our first hypothesis is that peer leaders will be able to 
effectively deliver both versions of MI. Our second hypothesis is that SGM male survivors who are 
randomized to tailored MI will significantly increase their engagement in formal mental health treatment, 
and reduce trauma-related symptoms as compared to SGM survivors who participate in traditional MI.
2.
Background: Describe the background information that led to the plan for this project. Provide 
references to support the expectation of obtaining useful scientific data. 
One in six men are sexually abused before their 18th birthday (Dube et al., 2005) and this number 
rises to one in four men who are sexually abused across their lifespan (Centers for Disease Control and 
Prevention, 2018). Survivors of sexual abuse and assault are at risk for a wide range of medical, 
psychological, behavioral, and sexual disorders (Maniglio, 2009). Indeed, sexual trauma is related to 
numerous psychiatric disorders, including PTSD, substance abuse and dependence, depression, anxiety, and 
suicidal behavior (Dube et al, 2005; Mohar, Buka, & Kessler, 2001). Men with histories of childhood and 
adult sexual victimization are more likely to report greater numbers of sexually transmitted infections, 
increased sexual risk for human immunodeficiency virus (HIV), higher sexual compulsivity, and greater 
gay-related stigma beliefs than men with no history of sexual assault (Hequembourg, Bimbi, & Parsons, 
2011). In addition, men who have experienced sexual abuse report significantly greater educational, 
occupational and relationship difficulties than non-abused men (Lisak, & Luster, 1994). Sexual trauma is 
also linked to medical illnesses, increased health care utilization and poor quality of life (Kartha et al., 
2008; Maniglio, 2009; Paras et al., 2009). 
SGM male survivors of sexual trauma face significant health disparities. They are exposed to 
traumatic events, particularly sexual violence, at higher rates than the general population (Brown & 
Pantalone, 2011; Rothman et al., 2011). In addition, SGM male survivors exhibit significantly more 
negative psychological outcomes related to their sexual identities, including lower self-esteem (Smith, 
Cunningham, & Freyd, 2016), sexual identity formation disturbances, and difficulties forming healthy adult 
intimate relationships (Williams, Kisler, Glover, & Sciolla, 2011). The cumulative traumatic impact of 
sexual abuse, in conjunction with individuals’ SGM status, also appears to result in higher rates of sexual 
re-victimization (Aosved, Long, & Voller, 2011), and anti-gay violence and discrimination (Badgett, 1995; 
Herek & Berrill, 1992; Human Rights Watch World Report, 2018; McLaughin, Hatzenbuehler, Xuan, & 
Conron, 2012; Safe Schools Coalition Annual Report, 2018).
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In addition to higher rates of sexual victimization, SGM males also experience significant minority 
stress, a term used to describe the sociopolitical stressors placed on individuals as a result of their minority 
status. Sexual orientation mental health disparities start relatively early in development. SGM individuals 
are disproportionately exposed to day-to-day discrimination, peer and parental rejection, unsupportive or 
hostile work or social environments, and unequal access to opportunities afforded to heterosexuals, 
including marriage, adoption and employment non-discrimination (Balsam, Rothblum, & Beauchine, 2005). 
Chronic expectations of rejection, internalized homophobia, alienation, and lack of integration with the 
community, can understandably lead to problems with self-acceptance (Hatzenbuehler, 2009; Meyer, 2003). 
As a result, SGM men may feel deficient, inferior or impaired. Further, they may view themselves as 
shameful, undesirable, underserving, or incapable of forming a loving relationship. Indeed, SGM 
individuals are significantly more likely than heterosexual males to report experiencing mental health 
problems, like depression and anxiety, as well as several behavioral health risks, such as alcohol use and 
risky sexual behavior (Hequembourg et al., 2011).
Preliminary studies suggest the acceptability, feasibility and potential ameliorative effects of peer-
based online support for trauma survivors (Hundt, Robinson, Arney, Stanley, & Cully, 2015; Watson & 
Andrews, 2017) as well as SGM individuals (Westra, Aviram, & Doell, 2011).
Motivational Interviewing to Engage SGM Male Survivors in Mental Health Treatment
Increasing SGM male sexual abuse survivors’ formal entry into mental health services may serve to 
address an important healthy disparity by alleviating psychiatric distress, increasing quality of life, and 
helping these men get the treatment they need and deserve. Motivational interviewing could help in 
assisting SGM men to enter mental health treatment. Motivational Interviewing is an evidence-based, 
patient-centered approach that explores and develops patients’ motivation and commitment to change 
within a collaborative, highly empathic patient-clinician relationship (Miller & Rollnick, 2013; Miller & 
Rose, 2009). Clinicians blend a combination of fundamental patient-centered counseling techniques (e.g., 
reflective listening) with advanced strategic methods (e.g., develop discrepancies between important life 
goals and current behavior) to elicit patient statements that favor change, called “change talk” and diminish 
those that argue against change, called “sustain talk.” The proficient use of MI methods has been shown to 
increase change talk and decrease sustain talk, which in turn has predicted behavior change (Apodaco et al., 
2014).
Originally empirically validated for reducing substance use disorders, MI is now used to help 
individuals develop motivation to change a variety of other health-related problem behaviors (e.g., 
treatment non-adherence, poor weight management) and mental health issues highly comorbid with trauma, 
such as depression, anxiety, and eating disorders (Burke, Arkowitz, & Menchola, 2003; Rubak, Sandbaek, 
Lauritzen, & Christensen, 2005). MI has also been used as stand-alone or adjunct intervention to help 
people engage in more intensive mental health services (Seal et al., 2012). For example, in a sample of Iraq 
and Afghanistan veterans with mental health difficulties, four sessions of telephone-delivered MI increased 
intent to engage in mental health services and resulted in some improvements in mental health symptoms 
(Seal et al., 2012). In addition, among depressed and anxious college-age men, MI had a small to moderate 
effect on both professional and non-professional help-seeking behavior (Syzdek, Green, Lindgren, & Addis, 
2016.
Though most often tested as an individually-delivered intervention, MI is also delivered in a group 
format (Westra et al., 2011), and a few randomized controlled trials have shown significant group MI 
treatment effects (Seal et al., 2012; Murphy & Rosen, 2006). Moreover, MI can be taught to a broad range 
of healthcare providers, including general practitioners (Soderlund, Madson, Rubak, & Nilsen, 2011), 
physician assistants (McLaughlin, Fasser, Spence, & Holcomb, 2010), and nurses (Lane, Johnson, Rollnick, 
Edwards, & Lyons, 2003). Thus, MI can be flexibly tailored and delivered to meet the needs of different 
populations and settings in which helping people become motivated for change is a core mission. In 
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addition, a recent national initiative found that peer specialists can be successfully trained to deliver MI in 
the Department of Veterans Affairs health care system (Tsai et al., 2017). Thus, MI interventions can be 
taught to peers and can be easily integrated into usual care, facilitating dissemination and improving 
sustainability of the intervention.
The efficacy and effectiveness of MI has also been studied when delivered online. In fact, MI has 
also been adapted for online formats for weight loss (Webber, Tate, & Quintilliani, 2008; West et al., 2016), 
substance abuse, and eating disorders (Hotzel et al., 2014). In fact, some clients reported that, the web-
based program felt less shameful, embarrassing, and uncomfortable than in-person treatments (Osilla, 
D’Amico, Diaz-Fuentes, Lara, & Watkins, 2012). 
3.
Research Plan: Summarize the study design and research procedures using non-technical language 
that can be readily understood by someone outside the discipline. If working with a Non-Government 
Organization (NGO) or other organization, be sure to highlight which are research-only activities and which 
activities would occur regardless of the research. If working with survey firms, please specify what research 
activities the research firm will be responsible for. 
We will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week 
group MI vs. MI with a trauma-informed SGM affirmative care approach. Randomization will be 
counterbalanced by treatment status: treatment naive versus treatment-experienced (prior treatment not 
within the past 60 days). Randomization will be based on a list of computer-generated random numbers. We 
will randomize 356 SGM male trauma survivors to either condition. Assessments will occur at baseline, 
post-intervention, and at 60- and 120-day follow-ups, from the end of the intervention.  
Comparators. Traditional MI will be compared to MI with trauma-informed SGM affirmative care (MI+). 
Groups will take place 1.5 hours once a week for 6-weeks and will be led by two peer specialists trained in 
MI or tailored MI. Groups will consist of approximately 8-10 members and be closed for the duration of the 
group. It is anticipated that new groups will begin every other month (allowing for a two week break 
between groups) to reduce burden on peer specialists and supervisors. 
Traditional MI groups. Six traditional MI groups will take place for 1.5 hours online facilitated by two peer 
specialists. 
Trauma-informed, SGM+ affirmative care MI groups. Six tailored MI groups will take place for 1.5 hours 
online facilitated by two peer specialists. Please see Appendix A for a detailed overview and outline of the 
major supplemental MI modules aimed at SGM minority stress, traditional masculinity, and male sexual 
abuse.
Through workshops and ongoing supervision/consultation, we will train peer leaders to 
competently deliver both versions of MI and conduct a randomized controlled trial comparing the two 
versions of MI to enhance treatment engagement in SGM male survivors with mental health problems. All 
SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete 
pre-test measures and be randomized to 6-week traditional MI delivered by peers in online groups or 6-
week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Randomization 
will be counterbalanced by treatment status: treatment naive versus treatment-experienced (prior treatment 
but not within the past 60 days). This same procedure of counterbalancing by treatment status was 
previously used in the randomized controlled trial of MI (Burke et al., 2003) to help Iraq and Afghanistan 
veterans with mental health difficulties engage in more mental health services. Participants will complete 
pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an 
online survey platform, to determine if there was an increase in formal mental health treatment engagement, 
and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and 
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illicit substance use). Peer leaders will co-facilitate groups throughout the study. It is anticipated that a peer 
leader  will run between 1-3 groups throughout the study.
Parent Study Screening and Participant Eligibility Criteria. 
Once recruitment advertisements are posted on the various websites (listed in detail below), those 
interested in finding out more information, will be directed to a website that contains the informed consent 
and Frequently Asked Questions about participation. Participants will then be asked to complete a short 
questionnaire including demographic questions with their contact information to be sent to a member of the 
research team to set up a screening appointment via telephone with the interested participant. 
Screening
Demographics and SGM Identification. Participants will be asked about their age, gender at birth, 
current gender identification, race/ethnicity, sexual orientation, marital status, highest level of education, 
and employment status at screening. Participants will also be asked about their treatment status to ensure 
eligibility (not currently in mental health treatment and/or have not been in treatment for past 60 days). 
Across post-interventions and follow-ups, participants will be asked if there are any changes to their 
employment, education, or marital status.  
Sexual Abuse Characteristics. Participants will be asked about the age of onset of sexual abuse; 
type of abuse (e.g., penetration, non-penetration); number of perpetrators; relationship to their 
perpetrator(s); and the frequency of the abuse. Participants will also be asked if someone had found out 
about the abuse while it was occurring, and if they received any kind of psychotherapy or counseling as a 
result. 
Current Experiences of Distress will be measured using the Center for Epidemiological Studies 
Depression Scale (CES-D; Radloff, 1977), a 20-item questionnaire that asks about experience and 
frequency of depressive symptoms over the past week. A score of 16 or higher identifies those individuals 
who are at risk for major depression. This score will be used as our cutoff for inclusion in the study. 
Life Events Checklist (Blake et al., 1995) is a self-report measure that screens for 16 potentially 
traumatic events across individuals’ lifetimes. Participants note whether the event happened to them 
personally, they witnessed it happen to someone else, they learned about it happening to someone close to 
them, or if it does not apply or does not fit. 
MINI (Sheehan et al., 1998) is a structured interview that takes approximately 15-20 minutes to 
administer. The MINI is used extensively in research studies to make fairly quick and accurate diagnoses of 
psychiatric disorders and will be used here to assess, in part, for exclusion criteria.
The Telephone-Assessed Mental State (TAMS; Lanska et al., 1993) is a brief, easily administered, 
easily scored cognitive assessment tool which can be administered by telephone. The TAMS uses 4 items 
from the extensively used Mini-Mental State Examination (MMSE) to assess for orientation to time and 
place, attention, and memory. In the population sample of Alzheimer’s disease patients, TAMS scores 
correlated strongly with those of instruments administered face to face, including the MMSE.
The Service Use and Resource Form (SURF; Rosenheck et al., 2016) is a questionnaire assessing 
current living situation, use of inpatient and outpatient mental health and alcohol or drug treatments, 
psychotropic medication use, and use of other support services. The SURF will be administered during 
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screening, baseline, post-intervention and follow-up. This measure takes approximately 10-15 minutes to 
complete. 
The Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) is a widely used 
measure of suicidality that has been successfully implemented across many settings (e.g., military, primary 
care, etc.). It has demonstrated good convergent and divergent validity with other multi-informant suicidal 
ideation and behavior scales and has high sensitivity and specificity for suicidal behavior classifications. It 
is also sensitive to change over time. The C-SSRS is available in several versions free of charge, including a 
brief 6-item screener which can be used as a self-report or interview measure. The C-SSRS screener will be 
administered during the phone screening interview and at baseline, post-intervention and follow-up 
assessments. Any participants endorsing “high-risk” responses (i.e. those coded in red) will be flagged, and 
Drs. Cook, Ellis, or Simiola will conduct a follow-up phone assessment to determine their suicide risk and 
make a final eligibility determination. 
Outcomes
Those participants who meet inclusion criteria will be provided a link to the online surveys for 
baseline assessment. Measures will include prior and current mental health treatment engagement, barriers 
and beliefs around seeking formal mental health treatment, as well as measures assessing symptomatology 
(e.g., substance use, depression, PTSD).  At the completion of the 6-week group, participants will complete 
post-intervention assessments and 60- and 120-day follow-up assessments on the various outcome 
measures. A summary of the timing and purpose of assessments is shown in Table 1. 
Baseline, Post-Intervention and Follow-up Outcomes
Primary Outcome: Mental Health Treatment Engagement. The primary outcome here will be the 
binary distinction between those who initiated mental health treatment/reinitiated mental health treatment 
versus those who did not. Mental health treatment engagement will be operationally defined as having ≥1 
visit(s) or scheduled appointments to any mental health services within 120 days of the last online group. 
Primary Outcome: Depression. Center for Epidemiological Studies Depression Scale (CES-D; 
Radloff, 1977) is a 20-item questionnaire that asks about experience and frequency of depressive symptoms 
over the past week. A score of 16 or higher identifies those individuals who are at risk for major depression. 
Secondary Outcome(s): will include PTSD, alcohol and drug abuse, quality of life, and service 
utilization.
PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that 
corresponds to the current psychiatric diagnostic criteria for PTSD.  
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; WHO ASSIST Working 
Group, 2002; Humeniuk et al., 2008) is an 8-item measure of participants’ use of alcohol, tobacco 
products, and other drugs across their lifetime and in the past three months. 
Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-
item scale that assesses functional impairment or quality of life related to trauma and PTSD. 
The Service Use and Resource Form (SURF; Rosenheck et al., 2016) is a questionnaire assessing 
current living situation, use of inpatient and outpatient mental health and alcohol or drug treatments, 
psychotropic medication use, and use of other support services. The SURF will be administered during 
screening, baseline, post-intervention and follow-up. 
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The Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) is a widely used 
measure of suicidality that has been successfully implemented across many settings (e.g.,  military, primary 
care, etc.). The C-SSRS is available in several versions free of charge, including a brief 6-item screener 
which can be used as a self-report or interview measure. The C-SSRS screener will be administered during 
the phone screening interview and at baseline, post-intervention and follow-up assessments. Any 
participants endorsing “high-risk” responses (i.e. those coded in red) will be flagged, and Drs. Cook, Ellis, 
or Simiola will conduct a follow-up phone assessment to determine their suicide risk and make a final 
eligibility determination. 
The Brief Dissociative Experiences Scale (DES-B Modified; Dalenberg & Carlson, 2010) is a 
brief 8-item self-report measure that assesses the severity of dissociative experiences in individuals aged 18 
and older. Higher scores indicate a greater severity of dissociative experiences. As the DES-B can track 
changes in the severity of brief dissociative experiences over time, participants will be asked to complete 
the measure at baseline, post-intervention, and follow-up assessments.
Potential Moderators:
Barriers to Help Seeking Scale (BHSS; Mansfield, Addis, & Courtenay, 2005) is a 31-item scale 
measures several barriers to help-seeking (e.g., need for control and self-reliance, minimizing problem and 
resignation, concrete barriers and distrust of caregivers, privacy, and emotional control). 
Conformity to Masculine Norms Inventory (CMNI-46; Parent & Moradi, 2009) assesses 
conformity to the following masculine norms: winning, emotional control, primacy of work, risk-taking, 
violence, heterosexual self-presentation, sexual activity, self-reliance, and power over women. 
Minority Stress Scale (MSS; Norcini Pala et al., 2017) is a 43-item questionnaire that assesses 
individuals’ experiences of stigmatization, discrimination, and internalized homophobia due to their sexual 
orientation. 
Working Alliance Inventory (WAI; Horvath & Greenberg, 1989), is a well-established measure of  
the therapeutic relationship. The measure contains three subscales (i.e., agreement on the goals of therapy, 
agreement on the tasks of therapy, and bond between client and therapist). 
Adult Resilience Measure – Revised (ARM-R; Resilience Research Centre, 2018; Jefferies, 
McGarrigle, & Ungar, 2018) is a 17-item scale of social-ecological resilience designed to measure the 
resources (individual, relational, communal and cultural) available to individuals that may bolster their 
resilience. 
Preferences Interview. A sample subset of the sample (N = 110) will be invited for a telephone 
interview where we will ask questions about treatment preferences (e.g., group versus individual, telehealth 
versus in person, etc.) to gain additional information from patients about their needs and wants for mental 
health treatment. Participants will be selected randomly from each intervention. Sampling will occur until 
110 interviews are completed. Participants will be invited for the interview during the post-intervention 
assessment and all interviews will be completed within three months (to allow for scheduling) of the 
participant completing the intervention.
Peer Specialists
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Peer Training/Treatment Integrity. We will utilize the Independent Tape Rater Scale (ITRS; 
Martino, Canning-Ball, Caroll, & Rounsaville, 2011), a 39-item measure with items rated on a 7-point 
Likert scale, to monitor adherence to and competence in MI concepts. The ITRS will assess the degree to 
which peer leaders delivered both interventions with fidelity (i.e., with adherence and competence). The 
ITRS includes items that cover therapeutic strategies that are MI consistent (e.g., reflections) or inconsistent 
(e.g., unsolicited advice). For this trial, we will add 15 items that detail key aspects of trauma-informed, 
SGM affirmative care (e.g., avoiding gendered language, affirming healthy expressions of sexual 
orientation and identity, affirming and validating strengths of SGM males, and reframing help-seeking as a 
focus on regaining control over one’s life).  For each item, raters evaluate the peers for adherence (i.e., the 
extent of intervention delivery) and competence (i.e., the skill/quality of intervention delivery) along 7-
point Likert scales. Namely, at least half the MI consistent items rated average or above for both adherence 
and competence. In addition, we will evaluate the degree to which peers addressed trauma-informed, SGM 
affirmative care during the session. Our investigative team has documented experience training ITRS raters 
to perform reliable ITRS session process ratings in randomized trials (Martino, Ball, Nich, Frankforter, & 
Carroll, 2008).
Fidelity monitoring will occur ad hoc by independent raters using audio-recordings of intervention 
sessions. At least 30% of the sessions (traditional MI and trauma-informed MI) will be coded (n =90). 
Three coders will rate each session. Dr. Steve Martino will host a training with the raters to familiarize them 
with the rating scales and interventions. The three raters will conduct the fidelity ratings over a six to eight 
month period (approximately) between June 2021 and February 2022. The three raters (Karen Hunkele, 
Tami Frankforter and Joanne Corvino) have previous experience conducting this task and will be 
supervised by Dr. Martino. Audio recordings of selected group sessions will be sent to the raters using 
Yale’s secure file transfer (FileLocker).
Assessment Measures. Peer specialists will also be asked to complete a reflective journaling 
exercise (see attached) after each treatment cycle they co-facilitate. In addition, they will complete several 
assessments measures (see attached) prior to their attendance at the MI training then again after they attend 
the MI training. Peer specialists will be asked to answer approximately three open-ended questions at the 
end of the study.
Table 1: Assessment Schedule
Assessment Name
Screening
Baseline
Post-
intervention
60-Day
Follow-
up
120-Day 
Follow-up
Peer 
Specialists
Independent Tape Rater Scale 
x
Demographic and SGM 
identification
x
x
x
x
x
Sexual abuse characteristics
x
Life Events Checklist
x
Mini International 
Neuropsychiatric Interview 
x
Telephone-Assessed Mental 
State (TAMS)
x
Male
Survivors
Columbia-Suicide Severity 
Rating Scale (C-SSRS)
x
x
x
x
x
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Brief Dissociative Experiences 
Scale (DES-B Modified for 
DSM-5)
x
x
x
x
Center for Epidemiological 
Studies-Depression Scale 
x
x
x
x
x
PTSD Checklist for DSM-5
x
x
x
x
Alcohol Smoking and 
Substance Involvement 
Screening Test (ASSIST)
x
x
x
x
Inventory of Psychosocial 
Functioning 
x
x
x
x
Barriers to Help Seeking Scale
x
x
x
x
Conformity to Masculine 
Norms Inventory
x
x
x
x
Minority Stress Scale 
x
x
x
x
Working Alliance Inventory
x
Service Use and Resource 
Form (SURF)
x
x
x
x
x
Adult Resilience Measure – 
Revised (ARM-R)
x
x
x
x
Participant Population: Provide a detailed description of the types of participants who will be recruited 
into this study. 
The study will include peer leaders from MaleSurvivor and Men Healing as well as emotionally distressed 
SGM male survivors who have not recently engaged in mental health care and will largely take place in 
online discussion groups.  
4.
Describe how access to the population will be gained in the study.
 
As an organization, MaleSurvivor and Men Healing have been active in trying to dispel  societal 
prejudice that keeps male survivors  from engaging in research and participating more actively in health 
care decision-making. As such, we will establish a community-based research advisory board to facilitate 
the identification and enlistment of participants. In conducting focus groups with male survivors through 
our PCORI Engagement Award, we met a number of survivors who expressed an interest in working with 
us on future research studies. We will enlist and collaborate with them on how best to approach survivors. 
We will also work with these survivors to develop plans to share the study progress and results in formats 
most useful to the different communities involved, including SGM participants, other survivors and their 
families. 
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5.
Participant classification: Check off all classifications of participants that will be specifically 
recruited for enrollment in the research project. Will participants who may require additional safeguards or 
other considerations be enrolled in the study? If so, identify the population of participants requiring special 
safeguards and provide a justification for their involvement.
☐Children
☐ Healthy 
☐Fetal material, placenta, or dead fetus
☐Non-English Speaking
☐ Prisoners
☐Economically disadvantaged persons
☐Decisionally Impaired
☐ Employees
☐Pregnant women and/or fetuses
☐Yale Students 
☐ Females of childbearing potential
 X No special populations will be specifically recruited for enrollment.
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential 
participants? ☐Yes 
No 
6.
Inclusion/Exclusion Criteria: What are the criteria used to determine participant inclusion or    
exclusion? 
Inclusion criteria will include 18+ age or older; English-speaking; men who have sex with men or 
individuals identifying as SGM males; individuals who report a history of sexual abuse; and individuals 
who self-report a minimum cut-off score of 16 or higher on depression, using a 20-item depression 
inventory. Similar to previous investigations with SGM males, we are using minimum distress scores to 
ensure that the sample adequately represents the population of SGM males who would be more inclined to 
seek intervention. A member of the research team will also administer the Mini International 
Neuropsychiatric Interview (MINI) to assist in determining participants’ eligibility. 
Exclusion criteria will include individuals who endorse active psychosis or cognitive impairment per the 
MINI and TAMS, respectively. We will also exclude SGM men who report that they are currently in formal 
mental health counseling. Participants who are actively suicidal will be excluded. The Columbia-Suicide 
Severity Rating Scale will be used to measure suicidal behavior and ideation. If a participant screens high 
risk a study psychologist will follow-up to assess imminent danger and provider resources as appropriate 
and noted in the protection of human subjects  section. 
SECTION V: RECRUITMENT/CONSENT AND ASSENT PROCEDURES 
1.
Recruitment Procedures: 
a. Describe how potential participants will be identified and contacted, and by whom.
In addition to posting recruitment advertisements on the MaleSurvivor website and discussion 
boards, participants will also be recruited through social and informational networking websites and mobile 
applications, and affiliate websites. The following male sexual abuse survivor websites will be used for 
recruitment: MaleSurvivor; 1in6; and Ark of Freedom Alliance. The following SGM websites will be used 
for recruitment: GLBT National Help Center, and The Association for Lesbian, Gay, Bisexual & 
Transgender Issues in Counseling. A full list of potential recruitment sites/organizations provided as an 
Appendix A. Flyers were created that target different populations and organizations (Appendix B). The 
flyers will direct interested persons to our study website for additional information, contact information, 
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further eligibility requirements and procedures for enrollment. Flyers will be provided to organizations as a 
recruitment tool. Flyers will also be used in listserv distributions/mass e-mails through the organizations. 
We will also recruit on social media and sexual networking websites (e.g., Facebook, Twitter). A list of 
potential social media messages is included in Appendix C. These will be posted on the social media pages 
of sites/organizations included in Appendix A. We anticipate snowballing recruitment through social media 
(sharing of posts). Research suggests that strategies that involve photos related to the target population, and 
that modalities such as Facebook may be the most promising due to its ability to select criteria such as 
relationship interests (men interested in men), gender, and ethnicity in recruiting SGM males online. The 
flyers will be attached to social media posts. We will also utilize op-ed pieces written for the public as a 
recruitment strategy. 
Study personnel including the investigators, research coordinator, research assistants will contact and 
consent participants. Consent will be obtained prior to screening patients. 
Are you collecting any information about the individuals prior to their signing a consent form? 
Yes ☐     No
If yes, indicate what information you will be collecting and how it will be gathered (phone screen, paper 
questionnaire, etc.) Click or tap here to enter text.
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used.
☒Flyers
☒ Internet/web postings
☐ Radio
☐ Posters
☒ Mass email solicitation
☐ Telephone
☐ Letter
☐ Departmental/Center website
☐ Television
☐ Through local NGO or other local contact
☐ Departmental/Center research boards
☐ Newspaper
☐ Table set-up / in-person recruitment of public   ☒ Snowball sampling
☐ Classroom recruitment
☒ Social Media (Twitter/Facebook): 
Facebook, Twitter, 
Instagram
☐ Other: 
3. Targeted Enrollment: Give the number of participants:
a.
  Targeted for enrollment at Yale for this protocol: 356 for the online groups. 
b.    If this is a multi-site study, give the total number of participants targeted across all sites.  
4.   How was this estimate derived? 
Because this study examines repeated measures outcomes with the two treatment conditions, assigned 
at the individual level, power analysis makes several assumptions: continuous outcomes, a linear link 
function, random effects covariance structure, and homogeneous covariance structure (within treatment 
groups). These analyses also assume testing for HTE effects. Conservatively assuming an effect size of .35, 
with a power of .80 and an alpha of .05, 137 subjects per group would be required. This represents a total 
completed sample of 274. Assuming a dropout rate of 20% (rounded up to 70, for nearest multiple of 2), 
this requires a recruited sample of at least 344. In a meta-analysis of 72 clinical trials, the initial effect size, 
that is 1-month post-intervention, was quite high (d = .77). However, the strength of the effect decreased 
over time, with effect sizes of .39 at 1-3 months, and .31 at 6-12 months.
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5.
Process of Consent/Assent (NOTE: When a study includes minors, parent provide permission [not 
consent] for the child’s participation, and the child provides assent for participation)
Informed consent is an ongoing process that is best suited by transparency and openness to 
participants. Thus, participants will give consent in the initial online screening contact form and verbally in 
the screening call. Participants will be provided with information about the nature of the study, as well as 
the expected time and energy commitment required to complete the assessments. It will also be explained to 
participants that they are consenting to be randomly assigned to one of two MI interventions (with brief 
explanation about content as well as frequency and length of sessions). 
Participants will be asked to provide informed consent online, prior to completing in the screening 
questionnaires. Consent will be required in order to access the assessment measures. If a participant does 
not provide consent, they will not engage in the screening assessment or be enrolled in the study. 
Peer specialists will also be asked to provide consent for participation in a research study (see 
attached form). They will also be asked to complete an attestation form (see attached) to ensure they agree 
to all requirements/commitments required to serve as a peer specialist (see attached). Information will be 
collected on peer specialists (e.g. demographic information such as age, race/ethnicity, education level, 
etc.). In addition, peer specialists will be asked to complete assessment measures (as documented above) 
and a reflective journaling exercise to capture their experiences leading the groups (see attached).  
If a participant informs the study staff that they are no longer able to participate in the group intervention 
(e.g. participant was randomized and then unable to complete all six online group sessions) the study staff 
will contact that participant to confirm receipt of their message and also note their eligibility to complete 
ongoing assessment measures (see example of outreach language with submission). Similarly, if a 
participant stops attending group, without explicitly informing the study staff of their inability to complete 
the six sessions we will contact them informing them they are still eligible to complete the follow-up 
assessment measures. If a participant withdraws from the study entirely, we will not contact them to gather 
additional data. 
Participants who engage in the online groups will be offered the opportunity to share their e-mail 
address with their fellow group participants and the two peer leaders for their group. Participants will be 
informed by the peer leaders during the 6th session that they will be provided a link to a consent form that 
will allow them to choose if they would like to share their e-mail address with fellow group members and/or 
peer leaders. They will be informed both during the 6th session (by the peer leaders) and in the online 
consent form (sent by the study staff) that sharing their information is completely voluntary. We will 
require that each participant provide written consent indicating 1) their preferred name to share, 2) their e-
mail address, and 3) to whom they provide permission to share their information with (see attached form). If 
a participant does not provide signed consent, or complete the form in its entirety, their information will not 
be shared. 
6.
Evaluation of Participant(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential participant’s ability and capacity to consent to the 
research being proposed, if applicable.
All potential participants will be administered the MINI during the screening process. The MINI is 
a structured interview that takes approximately 15-20 minutes to administer. The MINI is used extensively 
in research studies to make fairly quick and accurate diagnoses of psychiatric disorders and will be used 
here to assess, in part, for exclusion criteria and capacity evaluation.
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7.
Documentation of Consent/Assent: Specify the documents or verbal scripts that will be used 
during the consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given or spoken to participants. 
Please refer to the consent form included in this submission.
8.
Non-English-Speaking Participants: Explain provisions in place to ensure comprehension for 
research involving non-English speaking participants. Translated copies of all consent materials must be 
submitted for approval prior to use. Do you speak the local language? Will you require a translator? (If 
so, please elaborate on how the translators will be trained).
Non-English speakers will be excluded from this study.
9.
Are any of the study procedures likely to yield information subject to mandatory reporting 
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -incidents of child 
abuse, elderly abuse, etc.). Please verify to whom such instances will need to be reported. 
Not applicable. However, we have a data safety monitoring board in place:
General description of a monitoring plan: To ensure confidentiality, we have instituted a range of 
protocols. We will not include names and other protected health information in our publications, reports, or 
presentations. Wherever possible, we will refrain from using participants’ names and other protected health 
information. We will use standard research procedures for coding data and referring to participants by their 
unique ID number.  The document containing key decipher code will be destroyed immediately following 
the conclusion of the intervention.  
We will also have a data and safety monitoring plan for the study. Dr. Ilan Harpaz-Rotem, an 
Associate Professor in the Department of Psychiatry at Yale, will serve as the internal monitor for our study 
to ensure that we are approaching the participants in ways that are not coercive. In addition, Dr. Harpaz-
Rotem will serve as the psychological safety monitor and will detect patterns of possible adverse events and 
report these to the PI, who will notify the IRB in a timely fashion. Serious adverse events that are 
immediately reportable to the IRB would be death, a life-threatening experience (e.g., suicide attempt), and 
inpatient hospitalization. Dr. Ellis will oversee the data entry process to ensure that data is entered to 
maintain confidentiality and security. We do not anticipate a need for an interim analysis of the data.
Plans for ensuring necessary intervention in the event of adverse effects:  Dr. Jeffrey Sonis, a 
primary care physician and Associate Professor from the University of North Carolina has agreed to serve 
as an external safety officer. Dr. Sonis will receive reports prepared by the PI’s at 6-month intervals and 
review data on number of missing forms, number of potential participants excluded from participation, 
number of adverse events and serious adverse events, and number of terminations from the study. Dr. Sonis 
will prepare a report for the IRB every 6 months. The PI for this study, Dr. Cook, will be responsible for 
following established procedures for reporting adverse events to the Yale Human Investigations Committee, 
the funding source for this study, and other federal agencies as required by law.  
10.
Waiver of Consent/Documentation of Consent: In certain circumstances, the IRB may grant a 
waiver of documentation of consent, or a full waiver of consent, depending on the study. If you will 
request either a waiver of consent, or a waiver of signed consent for this study, complete the appropriate 
section below.  
☐Not Requesting any consent waivers 
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☐Requesting a waiver of signed consent (e.g., verbal or online consent only):
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will 
apply to recruitment activities only)
☐ Entire Study (Note that an information sheet may be required.)
 For a waiver of signed consent, address the following:

Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO ☐ 

Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☐
 
OR

Does the research pose greater than minimal risk? YES ☐    NO☐ 

Does the research include any activities that would require signed consent in a non-research context? 
YES ☐   NO ☐
 
☐ Requesting a waiver of consent (if you are not obtaining ANY consent):
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will 
apply to recruitment activities only)
☐ Entire Study 
For a waiver of consent, please address all of the following:

Does the research pose greater than minimal risk to subjects?  
☐ Yes   If you answered yes, stop. A waiver cannot be granted.  
☐ No

Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐

Why would the research be impracticable to conduct without the waiver? 
Click or tap here to enter text.

Where appropriate, how will pertinent information be returned to, or shared with subjects at a later 
date? Click or tap here to enter text.
Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either 
the entire study, or for recruitment purposes only. Note: if you are collecting PHI as part of a phone or 
email screen, you must request a HIPAA waiver for recruitment purposes.)
Choose one: 
☐ For entire study 
 For recruitment/screening purposes only 
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated 
HIPAA research authorization form available on the University’s HIPAA website at hipaa.yale.edu.
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i. Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this 
data: 
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to obtain the 
subject’s signed authorization for use/disclosure of this data: 
In order to contact participants to determine eligibility and obtain consent a waiver of HIPAA Authorization 
is needed. Due to the nature of the recruitment taking place online we will obtain participant’s names, e-
mail addresses and phone numbers prior to obtaining informed consent. 
SECTION VI: PROTECTION OF RESEARCH PARTICIPANTS
1.
Confidentiality & Security of Data: Describe the steps that will be taken to secure the data during 
storage, use and transmission as outlined in the below sections.  NOTE: Data can include paper files, data 
on the internet or websites, computer files, audio/video files, photographs, etc. and should be considered in 
the responses to the below sections.   Click or tap here to enter text.
We will take several steps to protect participant confidentiality as well as reduce burden. Methods 
of contact will involve telephone, web and computer-based measurement as well as online-based discussion 
groups at the participants’ convenience. According to MaleSurvivor, peers who currently lead discussion 
groups, there have been no complaints of grievances or reports of emotional hardship. On the contrary, 
many have expressed appreciation for the opportunity to participate in the current peer-led support groups. 
We will minimize risks to participants by thoroughly explaining to them that participation in the 
study is voluntary and that the decision not to participate will have no bearing on their connection to 
MaleSurvivor or Men Healing. Participants’ first names or preferred nicknames/pseudonyms will only be 
used during the discussion groups to build rapport. In publications or presentations, we will report data in 
aggregate form and/or change names and disguise the identity of any persons we describe or quote for 
purposes of illustration or example. The audio-files will be labeled only by a non-identifying code and sent 
to the professional transcriptionist via a secure website. Pseudonyms will be used in all transcribed files, 
removing all subject names. A confidentiality agreement, BAA, and consultant agreement will be executed 
with the transcription company prior to transfer of any files. Interview recordings will be sent to the 
transcriptionist using a unique identifier and through Kaiser Permanente’s Secure File Transfer system. 
Audio files will be sent using Kaiser Permanente’s Secure File Transfer program which is powered by the 
Accellion platform and used by healthcare organizations to send protected health information safely. The 
Secure File Transfer program has SSL/TLS 1.2 encryption, secure client communication, secure data 
transfer between server nodes, secure transfer of large files, and a digital fingerprint to detect tampering. 
Files will also be returned by the transcriptionist using the Kaiser Permanente Secure File Transfer 
program. The transcriptionist will de-identify and names (including nicknames) recorded in the audio file 
with the pseudonym such as “Moderator” and “Participant” or “interviewer” and “interviewee”. To 
delineate between the persons the transcriptionist will label each individual with a number e.g. “Participant 
1” or “Participant 5”. Audio files will be sent to a professional transcriptionist within one week of the 
completed recording. Audio files will be destroyed as soon as the transcribed files are received back from 
the professional transcriptionist and reviewed by the investigative team to ensure completeness. The review 
of the transcribed files will occur within one week of receiving the files from the transcriptionist.
Confidentiality of data files will be achieved by separating personally identifiable information from 
the web-based survey responses and transcribed interviews. All identifying information will be kept in 
secure locked files, accessible only to the study team and will be destroyed at the end of a five-year period. 
Responses to the web-based measurements will be stored on a Yale-approved secure server, behind the 
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firewall. This information will be protected to the fullest extent possible using modern encryption 
technology, thus reducing the risk of unauthorized data interception.
A data use agreement will be fully executed between Yale University and Nova Southeastern 
University (Dr. Amy Ellis’ primary institution) prior to any data transfer. Similarly, a data use agreement 
will be fully executed with Kaiser Permanente, Center for Health Research prior to any data transfer. Secure 
file transfer, approved by Yale University IT, will be the sole method for data transfer. 
2.
What participant information will you be collecting? Describe the identifiers that will be included 
or associated with the data and/or specimens (e.g., names, addresses, telephone/fax numbers, email 
addresses, dates (date of birth, admission/discharge dates, etc.), medical record numbers, social security 
numbers, health plan beneficiary numbers, etc.) Names, telephone number, e-mail address, date of birth, 
and postal address for those who request payment via postal mail. 
Other potentially identifying information to be collected:
☒Audiotapes
☒Videotapes
☐Faces (focus groups, photographs or other way that an individual would be physically recognized)
☐Potential for identification from the bulk of the information, even if direct identifiers are not collected 
(deductive disclosure).
3.
How will the research data be collected and recorded? 
Training videos will be created. While we will do our best to only video record the trainer, it is possible that 
other persons in the room will be included in the video. Therefore, we will obtain consent to video record at 
the time of invitation to the training event to explicitly inform participants that by attending the training they 
are agreeing to be video recorded. Individuals who decline consent will not attend the training event. 
Similarly, to measure fidelity we will audio record a small subset of the intervention groups. Participants will 
be provided information about the audio recording prior to consenting to the study. Participants unwilling to 
be audio recorded will be excluded from participation. 
4.
If identifiers will be associated with the data and/or specimens, describe whether a record or list 
containing a code (i.e., code number, pseudonyms) will be used, where the list will be stored, who will have 
access to the list and when it will be destroyed.
Participants’ first names or preferred nicknames/pseudonyms will only be used during the discussion groups 
to build rapport. In publications or presentations, we will report data in aggregate form and/or change 
names and disguise the identity of any persons we describe or quote for purposes of illustration or example. 
The audio-files will be labeled only by a non-identifying code and sent to the professional transcriptionist 
via a secure website. Confidentiality of data files will be achieved by separating personally identifiable 
information from the web-based survey responses and transcribed interviews. 
5.
Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) and/or 
specimens will be stored.
 All identifying information will be kept in secure locked files, accessible only to the study team and will be 
destroyed at the end of a five-year period. Responses to the web-based measurements will be stored on a 
Yale-approved secure server, behind the firewall. This information will be protected to the fullest extent 
possible using modern encryption technology, thus reducing the risk of unauthorized data interception. Drs. 
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Cook, Ellis, and Simiola along with the project coordinator will have access to individually identifiable 
private information. Raw data will be stored in a double locked file cabinet located in data storage that only 
they will have access to. All electronic data will be password protected and stored on a secured, encrypted 
server which has limited access restricted to the research team. First names and any information volunteered 
during the course of the MI interventions will be known by peer specialists leading the groups as well as 
study personnel who will code the group sessions prior to sharing for fidelity analyses or any other data 
analyses.
Audio files will be sent to a professional transcriptionist within one week of the completed recording. Audio 
files will be destroyed as soon as the transcribed files are received back from the professional 
transcriptionist and reviewed by the investigative team to ensure completeness. The review of the 
transcribed files will occur within one week of receiving the files from the transcriptionist.
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical 
reason a device cannot be encrypted please submit an exception request to the Information Security, Policy 
and Compliance Office by clicking on URL http://its.yale.edu/egrc or email it.compliance@yale.edu 
 
6.
Identify who will have access to the data and/or specimens. If the data and/or specimens will be 
transferred to and/or from outside collaborators, identify the collaborator to whom the data and/or 
specimens will be transferred and how the data and/or specimens will be transferred.   
Drs. Cook, Simiola and Ellis along with the project coordinator will have access to individually 
identifiable private information.
7.
What will be done with the data when the research is completed? Are there plans to destroy the 
identifiable data or the link to personal identifiers? If yes, describe how, by whom and when identifiers will 
be destroyed. If no, describe how the data and/or identifiers will be secured. Identifiable data will be destroyed 
at the earliest date based on federal and local regulations. Dr. Cook will work with Yale ITS to ensure that 
data is destroyed in an appropriate manner. 
8.
Will a Certificate of Confidentiality be needed? (See also the NIH Certificate of Confidentiality Kiosk, 
http://grants.nih.gov/grants/policy/coc/index.htm) We received a Certificate of Confidentiality from the NIH 
on April 25, 2019, and have submitted all appropriate documentation to the IRB.
SECTION VII: POTENTIAL RISKS AND BENEFITS
1.
Risks: Describe the reasonably foreseeable risks, including risks to participant privacy, discomforts, or 
inconveniences associated with participants participating in the research. Note: All studies have the 
potential for risk, if not physical, there may be psychological, reputational, or financial risks or risks 
to breach of confidentiality.
There are no foreseeable physical or medical risks to participants in this study. There is extensive 
research showing that assessing study participants’ trauma history or subsequent mental health difficulties 
does not unduly upset participants. The general findings across research studies in non-psychiatric samples 
are that distress responses are infrequent, mild, and transitory. Although, some studies have found that those 
with more severe trauma histories or those with PTSD symptoms had more distress reactions (Galea et al., 
2003; Institute of Medicine, 2007). Interestingly, emotion or temporary distress in trauma studies is, at 
times, reported to correlate positively with perceived importance and general positive evaluation of the 
research (Griffin, Resick, Waldrop, & Mechanic, 2003). This underlines that research that involves 
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disclosure of trauma, although difficult, can be beneficial. Indeed, disclosure of trauma has been associated 
with empirically measured physical as well as mental health benefits (Kluemper & Dalenberg, 2014; 
Lutgendorf & Antoni, 1999).
However small these risks may be, we will include in the consent form that, it is possible that some 
people will be upset by talking about some of their difficult past personal experiences. Further, we will 
make it clear that participants may stop the research process at any time and that any question can be 
skipped at any time. In the event that participants wish to talk further about any such difficult experiences, 
they will be given the telephone numbers of study staff, a local hotline, and information for mental health 
providers in their area. A breach of confidentiality is also possible, but not likely, and the data coding 
process will be used to help protect participant confidentiality. 
2.
Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
We will take several steps to protect participant confidentiality as well as reduce burden. Methods of 
contact will involve telephone, web and computer-based measurement as well as online-based discussion 
groups at the participants’ convenience. According to MaleSurvivor, peers who currently lead discussion 
groups, there have been no complaints of grievances or reports of emotional hardship. On the contrary, 
many have expressed appreciation for the opportunity to participate in the current peer-led support groups. 
We will minimize risks to participants by thoroughly explaining to them that participation in the study 
is voluntary and that the decision not to participate will have no bearing on their connection to 
MaleSurvivor or Men Healing. Participants’ first names or preferred nicknames/pseudonyms will only be 
used during the discussion groups to build rapport. In publications or presentations, we will report data in 
aggregate form and/or change names and disguise the identity of any persons we describe or quote for 
purposes of illustration or example. The audio-files will be labeled only by a non-identifying code and sent 
to the professional transcriptionist via a secure website. Audio-files will be sent to a professional 
transcriptionist within one week of the completed recordings. Audio-files will be destroyed as soon as the 
transcribed files are received back from the professional transcriptionist and reviewed by the investigative 
team to ensure completeness. The review of the transcribed files will occur within one week of receiving 
the files from the transcriptionist. The video recording of the motivational interviewing training will be 
limited to the trainers as much as possible. Prior to distributing the training video to peer moderators unable 
to attend the training we will work with the video editor to ensure that all participant’s identity is disguised 
(e.g. through blurring images or using black out techniques). The video file will be sent via e-mail to peer 
moderators. The video will require a password to access it. Raw footage from the training will be deleted 
within 6 months of the training or after the final edited version of the video is produced, whichever comes 
first.
Confidentiality of data files will be achieved by separating personally identifiable information from the 
web-based survey responses and transcribed interviews. All identifying information will be kept in secure 
locked files, accessible only to the study team and will be destroyed at the end of a five-year period. 
Responses to the web-based measurements will be stored on a Yale-approved secure web server. This 
information will be protected to the fullest extent possible using modern encryption technology, thus 
reducing the risk of unauthorized data interception.
A data use agreement will be fully executed between Yale University and Nova Southeastern 
University (Dr. Amy Ellis’ primary institution) prior to any data transfer. Similarly, a data use agreement 
will be fully executed with Kaiser Permanente, Center for Health Research prior to any data transfer. Secure 
file transfer, approved by Yale University IT, will be the sole method for data transfer. 
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A confidentiality agreement will be signed and executed with the professional transcription company 
and the videography company (CinemaSmith).
If, during the phone screening interview, any participant endorses a “high-risk” response on the C-
SSRS screener (i.e., any response coded in red suggesting high risk of suicide), this will be flagged by the 
interviewer and brought to the attention of the Principal Investigator and investigative team. Drs. Cook, 
Ellis, or Simiola will then conduct a follow-up phone assessment to determine the participant’s suicide risk. 
If the participant is actively suicidal (i.e., has imminent suicidal intent and plan), they will be advised to go 
to their local hospital emergency room and will be provided with tailored referrals to mental health services 
based on their location. If a participant reports significant emotional distress, passive or active suicidal 
ideation, or thoughts of hurting someone else during the study protocol, they will be provided with 
information for seeking additional help including being advised to go to their local hospital emergency 
room. (Please see attached resources sheet that provides the minimum information that will be posted: 1) 
during each intervention meeting (online) and reviewed at the start of the session and; 2) at the end of each 
online assessment (screening, baseline, post-intervention, 60-day follow-up, 120-day follow-up)). 
Peer leaders  will be trained during a 3-day in-person meeting specifically on identifying and 
managing emotional distress. They will also get ongoing training during weekly supervision where 
supervising psychologists will check in weekly with peer specialists about any distress observed or noted in 
their group(s). Peer leaders  will be required to alert the study PI via phone and e-mail within 30 minutes of 
the conclusion of the session when the participant expressed, or the peer specialist identified, emotional 
distress. The PI will directly contact the participant via phone to assess current risk and needs. When 
appropriate, the PI will provide area specific resources to the participant based on their location. The PI will 
utilize databases such as the clinician directory of the American Psychological Association and the 
International Society for Traumatic Stress Studies to make a local referral for the patient. In addition, the PI 
will provide the patient with information to the nearest emergency room, based on the participants stated 
location. 
3.
Data and Safety Monitoring Plan:  Include an appropriate Data and Safety Monitoring Plan (DSMP) 
based on the investigator’s risk assessment stated below. (Note: the HSC will make the final 
determination of the risk to subjects.).
a.
What is your assessment of the overall risk level for subjects participating in this study? 
More than minimal risk.
b.
If children are involved, what is your assessment of the overall risk level for the children 
participating in this study? Not applicable.
c.
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are  
 available here http://your.yale.edu/policies-procedures/other/data-and-safety-monitoring-
plan-template  for
i.
Minimal risk
ii.
Greater than minimal/moderate risk
1. Personnel responsible for the safety review and its frequency:
The PI will be responsible for monitoring the data, assuring protocol compliance, and conducting 
the safety reviews at the specified frequency, which must be conducted at a minimum of every 6 months 
(including when re-approval of the protocol is sought). During the review process, the PI (monitor) will 
evaluate whether the study should continue unchanged, require modification/amendment, or close to 
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enrollment. Either the PI or the IRB have the authority to stop or suspend the study or require 
modifications.
2. The risks associated with the current study are deemed greater than minimal for the following 
reasons: (choose those that apply)
We do not view the risks associated with the online interventions as minimal risks. Although we have 
assessed the proposed study as one of greater than minimal risk, the potential exists for anticipated and/or 
unanticipated adverse events, serious or otherwise, to occur since it is not possible to predict with certainty 
the absolute risk in any given individual or in advance of first-hand experience with the proposed study 
methods. Therefore, we provide a plan for monitoring the data and safety of the proposed study as follows:
 
To ensure confidentiality, we have instituted a range of protocols. We will not include names and 
other protected health information in our publications, reports, or presentations. Wherever possible, we will 
refrain from using participants’ names and other protected health information.  We will use standard 
research procedures for coding data and referring to participants by their unique ID number.  The document 
containing key decipher code will be destroyed immediately following the conclusion of the intervention.  
We will also have a data and safety monitoring plan for the study. Dr. Ilan Harpaz-Rotem will serve 
as the internal monitor for our study to ensure that we are approaching the participants in ways that are not 
coercive. In addition, Dr. Harpaz-Rotem will serve as the psychological safety monitor and will detect 
patterns of possible adverse events and report these to the PI, who will notify the IRB in a timely fashion. 
Serious adverse events that are immediately reportable to the IRB would be death, a life-threatening 
experience (e.g., suicide attempt), and inpatient hospitalization. Dr. Cook will oversee the data entry 
process to ensure that data is entered to maintain confidentiality and security. We do not anticipate a need 
for an interim analysis of the data.
Plans for ensuring necessary intervention in the event of adverse effects:  As mentioned above, 
Dr. Jeffrey Sonis has agreed to serve as an external safety officer. Dr. Sonis will receive reports prepared by 
the PI’s at 6-month intervals and review data on number of missing forms, number of potential participants 
excluded from participation, number of adverse events and serious adverse events, and number of 
terminations from the study. Dr. Sonis will prepare a report for the IRB every 6 months. The PI for this 
study, Dr. Cook, will be responsible for following established procedures for reporting adverse events to the 
Yale Human Investigations Committee, the funding source for this study, and other federal agencies as 
required by law.
3. Attribution of Adverse Events:
Adverse events will be monitored for each subject participating in the study and attributed to the study 
procedures / design by the PI, Dr. Cook, according to the following categories:
a.) Definite: Adverse event is clearly related to the study.
b.) Probable: Adverse event is likely related to the study.
c.) Possible: Adverse event may be related to the study.
d.) Unlikely: Adverse event is likely not to be related to the study.
e.) Unrelated: Adverse event is clearly not related to the study.
4. Plan for Grading Adverse Events:
The following scale will be used in grading the severity of adverse events noted during the study:
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1.
Mild adverse event
2.
Moderate adverse event
3.
Severe adverse event
5. Plan for Determining Seriousness of Adverse Events:
Serious Adverse Events:
In addition to grading the adverse event, the PI will determine whether the adverse event meets the 
criteria for a Serious Adverse Event (SAE).  An adverse event is considered serious if it results in any of the 
following outcomes:
1.
Death;
2.
A life-threatening experience in-patient hospitalization or prolongation of existing hospitalization; 
3.
A persistent or significant disability or incapacity; 
4.
A congenital anomaly or birth defect; OR
5.
Any other adverse event that, based upon appropriate medical judgment, may jeopardize the 
subject’s health and may require medical or surgical intervention to prevent one of the other 
outcomes listed in this definition. 
An adverse event may be graded as severe but still not meet the criteria for a SAE.  Similarly, an 
adverse event may be graded as moderate but still meet the criteria for an SAE.  It is important for the PI to 
consider the grade of the event as well as its “seriousness” when determining whether reporting to the IRB 
is necessary.
6. Plan for reporting UPIRSOs (including Adverse Events) to the IRB
The PI will report the following types of events to the IRB: 
Any incident, experience or outcome that meets ALL 3 of the following criteria:
1.
Is unexpected (in terms of nature, specificity, severity, or frequency) given (a) the research 
procedures described in the protocol-related documents, such as the IRB-approved protocol and 
informed consent document and (b) the characteristics of the subject population being studied; 
AND 
2.
Is related or possibly related to participation in the research (possibly related means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); AND
3.
Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, legal, or social harm) than was previously known or recognized.
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) may be medical or non-
medical in nature and include – but are not limited to – serious, unexpected, and related adverse events 
and unanticipated adverse device effects.  Please note that adverse events are reportable to the IRB as 
UPIRSOs only if they meet all 3 criteria listed above.
These UPIRSOs/SAEs will be reported to the IRB in accordance with IRB Policy 710, using the appropriate 
forms found on the website. All related events involving risk but not meeting the prompt reporting 
requirements described in IRB Policy 710 should be reported to the IRB in summary form at the time of 
continuing review. If appropriate, such summary may be a simple brief statement that events have occurred 
at the expected frequency and level of severity as previously documented.  In lieu of a summary of external 
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events, a current DSMB report can be submitted for research studies that are subject to oversight by a 
DSMB (or other monitoring entity that is monitoring the study on behalf of an industry sponsor).
7. Plan for reporting adverse events to co-investigators on the study, as appropriate the protocol’s 
research monitor(s), e.g., DSMBs, study sponsors, funding and regulatory agencies, and regulatory 
and decision-making bodies.
For the current study, the following individuals, funding, and/or regulatory agencies will be notified (choose 
those that apply):
 All Co-Investigators listed on the protocol.
□ National Institutes of Health
□ National Science Foundation
 Study Sponsor
Other Data Safety Monitoring Board (DSMB) or Committee (DSMC)
The PI, Dr. Joan Cook, will conduct a review of all adverse events upon completion of every study subject. 
Dr. Cook will evaluate the frequency and severity of the adverse events and determine if modifications to 
the protocol or consent form are required.
d. For multi-site studies for which the Yale PI serves as the lead investigator:
i.
How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? Click or tap here to enter text.
ii.
What provisions are in place for management of interim results? Click or tap here to enter 
text.
iii.
What will the multi-site process be for protocol modifications? Click or tap here to enter text.
4.
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the participant(s) or to society at large. (Payment of participants is not considered a 
benefit in this context of the risk benefit assessment.) 
In general, we believe that participants who take part in this research are contributing towards the 
care, treatment and well-being of countless numbers of people who have experienced sexual abuse or 
assault across their lifespan and have resulting emotional distress. In addition, participation contributes 
towards the advancement of science and may benefit those who experience sexual assault at some time in 
the future. Potential other benefits include taking an active role in one’s own healthcare; exercising one’s 
autonomy and helping to combat feelings of helplessness; having the possibility of trying a promising 
adapted evidence-based psychotherapy that is not yet widely available; and having the chance to potentially 
improve one’s own mental health, psychological functioning, and quality of life. Some participants in this 
clinical research study may benefit from the extra attention from a dedicated team and community that is 
specifically focused on their health care and carefully monitoring any potential side effects. 
         SECTION VIII: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1.
Alternatives: What other alternatives, if any, are available to the study participants outside of the 
research?
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Other than declining participation, there are no alternatives to the proposed study of which we are 
aware.  
2.
Payments for Participation (Economic Considerations): Describe payments that will be made to 
participants, if any, the amount and timing of payments, and the conditions for receiving this compensation 
(if applicable). If you plan to hold a drawing, be sure to include the following on any consent or recruitment 
materials mentioning the lottery: 1) the value of the prize; 2) the sponsor of the prize (this cannot be a 
federal funding source); 3) the odds of winning; and 4) that there are no restrictions to winning.
Research subjects will be paid for their participation in assessment. For each completed assessment 
they will receive $20 for their participation.
Peer leaders will receive $180.00 for each group they co-facilitate. Specifically, they will receive $60.00 at 
the end of the third group session and another $60.00 at the end of the sixth group session they co-facilitate.  
Peer leaders  will receive an additional $60.00 at the completion of the end of the 8th supervision session. 
This makes the total compensation for the peer leaders co-facilitating a group $180.00 per group. In 
addition, peer leaders  will also be asked to participate in either an in-person or online (previously recorded) 
training for the intervention for which you they are co-leading. If attending in person travel expenses (e.g. 
train, airfare, ground transportation) will be covered by the research award to host them in New Haven, 
Connecticut. Lodging and per diem expenses will also be covered by the study for up to 3 days. In addition 
as a token of our appreciation you they will be compensated $100.00 per day (maximum 3 days) for their 
attendance in the training.
Participants will be given a choice regarding how they would like to receive payment: either by postal mail 
or via e-mail. Checks will be mailed to participants, if this is their preferred method. Electronic gift cards 
will be e-mailed to those who prefer an e-mail delivery. 
3.
Costs for Participation (Economic Considerations): Clearly describe the participant’s costs 
associated with participation in the research, if any, and the interventions or procedures of the study that 
will be provided at no cost to participants.    
Interventions will be at no cost to the participant. A travel stipend will be provided for peer 
specialists attending various trainings.  
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Yale University
Page 1 of 4
Research Study Summary:
We are asking you to join a research study. The purpose of this research study is to examine how 
different types of online peer support can help male survivors reduce their emotional struggles. 
In addition, we are interested in seeing if the interventions we are testing can be effectively 
delivered by peer moderators, such as yourself. Study activities will include co-leading at least 
two online discussion groups for male survivors of sexual assault, which occur for 6 weeks each 
for 1.5 hours per session.  In addition, you will be asked to complete rating scales after each 
group session about whether or not you felt you covered each part of the treatment manual. We 
anticipate completion of the rating scales will take approximately 10 minutes of your time. We 
will also ask you to answer brief questions about your experience co-leading the groups, what 
you learned as a peer moderator, and other reflections you might have about your experience. As 
a peer moderator, you will also be asked to participate in one hour of weekly supervision per 
week with two psychologists. Your involvement will require approximately 20 hours over the 
course of each group cycle. There are no known or anticipated risks associated with this study.  
However, some questions or discussion online may make you uncomfortable. The study may 
have no benefits to you. By participating in this research study, you are contributing towards the 
advancement of knowledge on trauma treatment and may benefit those who experience sexual 
assault at some time in the future. Taking part in this study is your choice. You can choose to 
take part, or you can choose not to take part in this study. You also can change your mind at any 
time. Whatever choice you make will not have any effect on your relationship with Yale 
University. If you are interested in learning more about the study, please continue reading, or 
have someone read to you, the rest of this document. Ask the study staff questions about 
anything you do not understand. Once you understand the study, we will ask you if you wish to 
participate; if so, you will have to sign this form.
Verbal/Online Informed Consent Script for Participation in a Research Study
HSC # 2000024842
Hi, my name is Dr. Joan Cook and I am a psychologist and an associate professor from Yale 
University. I am conducting a research study to examine how different types of online peer 
support can help male survivors cope with trauma-related emotional struggles and feel more 
comfortable seeking help for related issues. In addition, our study team is interested in seeing if 
the interventions we are testing can be effectively delivered by peer moderators, such as yourself.
Participation in this study will involve co-leading at least two online discussion groups for male 
survivors of sexual assault, which occur for 6 weeks each for 1.5 hours per session. In addition, 
you will be asked to complete rating scales after each group session about whether or not you felt 
you covered each part of the treatment manual. We anticipate completion of the rating scales will 
take approximately 10 minutes of your time. We will also ask you to keep answer brief questions 
about your experience co-leading the groups, what you learned as a peer moderator, and other 
reflections you might have about your experience. As a peer moderator, you will also be asked to 
participate in one hour of weekly supervision per week with two psychologists. Your 
involvement will require approximately 20 hours over the course of each group cycle. While we 
cannot compensate you on at an hourly rate you will receive $180.00 for each group you co-
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APPROVED BY THE YALE UNIVERSITY IRB 2/20/2020
Yale University
Page 2 of 4
facilitate. Specifically, you will receive $60.00 at the end of the third group session and another 
$60.00 at the end of the sixth group session you co-facilitate.  You will receive an additional 
$60.00 at the completion of the end of the 8th supervision session. This makes the total 
compensation for co-facilitating a group $180.00 per group. According to the rules of the 
Internal Revenue Service (IRS), payments that are made to you as a result of your participation 
in a study may be considered taxable income. Payment for co-facilitating groups and your 
participation in supervision will be in the form of a check, mailed directly to you at the address 
you provide to the research staff. Alternatively, you may request your payment in the form of an 
electronic gift card, which will be e-mailed to you. 
We hope to enroll 20 peer moderators into this study and 344 male survivor group participants. 
The study will run for 5 years, in total.  However, we are asking for your participation in the first 
three years of the study only.
You will also be asked to participate in either an in-person or online (previously recorded) 
training for the intervention for which you will be co-leading. If attending in person your travel 
arrangements will be paid for and made by the research project, in compliance with Yale’s travel 
policies and those of the funder, to host you in New Haven, CT. Lodging and per diem expenses 
will also be covered by the study for up to 3 days. In addition as a token of our appreciation you 
will be compensated $100.00 per day (maximum 3 days) for your attendance in the training. 
Attendance at the in person training requires your agreement to be video recorded. The in-person 
training will be video recorded for distribution to those who are unable to attend in person. The 
video will focus primarily on the trainers, however it is possible that you will also appear in the 
video. A professional videographer from the company, CinemaSmith, will record the training 
and edit the footage to remove images of attendees other than the trainers (such as yourself) as 
best as possible.  The videographer and video editor from CinemaSmith will complete a 
confidentiality agreement prior to the taping of the training. While we cannot guarantee that your 
image will not appear in the video, we will do everything we can to blur your face. The video 
recording will only be shared with other potential peer moderators, such as yourself, and will be 
password protected. Raw footage from the training will be deleted within 6 months of the 
training or after the final edited version of the video is produced, whichever comes first. 
There are no known or anticipated risks associated with this study.  However, some questions 
may make you uncomfortable and there is the possible risk of loss of confidentiality.  Every 
effort will be made to keep your information confidential; however, this cannot be guaranteed. 
You may withdraw your consent for participation in this research study at any time by writing to 
the Principal Investigator:
Joan Cook, Ph.D.
Yale University
Department of Psychiatry
300 George Street, Suite 901
New Haven, CT 06511
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APPROVED BY THE YALE UNIVERSITY IRB 2/20/2020
Yale University
Page 3 of 4
By participating in this research project you are contributing towards the care, treatment and 
well-being of countless numbers of men (and women) who have experienced sexual abuse or 
assault across their lifespan. In addition, participation contributes towards the advancement of 
behavioral science and may benefit those who experience sexual assault at some time in the 
future.
Participation in this research study requires your permission to be audio-recorded. Your name or 
other identifiers will not be associated with the audio-file, which will be transcribed by a 
professional transcriptionist. Audio recordings will be used to measure adherence to the content 
of the group treatment. By signing this consent you are also agreeing to audio- recording of the 
group intervention sessions.  The audio recordings will be sent outside of Yale for transcription. 
A confidentiality agreement will be executed with the transcription company prior to transfer of 
any files. The transcriptionist will de-identify and names (including nicknames) recorded in the 
audio file with the pseudonym “Moderator” and “Participant”. To delineate between the persons 
the transcriptionist will label each individual with a number e.g. “Participant 1” or “Participant 
5”. Audio files will be sent to the professional transcriptionist within one week of the completed 
recordings. Audio files will be destroyed as soon as the transcribed files are received back from 
the professional transcriptionist and reviewed by the investigative team to ensure completeness. 
The review of the transcribed files will occur within one week of receiving the files from the 
transcriptionist.
All of your responses will be held in confidence.  Only the researchers involved in this study and 
those responsible for research oversight (such as representatives of the Yale University Human 
Research Protection Program, and the Yale University Human Subjects Committee, and offices 
responsible for fiscal monitoring) will have access to any information that could identify that you 
provide. We will ask you to identify yourself in groups using a nickname or only your first name 
(not to include surname/last name). We will use a coding system to randomly assign a number 
associated with any information we get from you. Only the investigative team (Drs. Cook Amy 
Ellis, and Vanessa Simiola and their project coordinator) will have access to the key. This means 
that identifiable data such as your name, telephone number and e-mail address will be shared 
amongst the investigative staff. Drs. Ellis and Simiola are not affiliated with Yale University. 
They will conduct portions of this research study including the screening interview and post-
intervention telephone interview from their respective organizations. Drs. Ellis and Simiola are 
associated Nova Southeastern University and Kaiser Permanente, Hawaii, respectively. Any 
exchange of protected health information (such as your name, telephone number, or e-mail 
address) or coded data will take place behind the Yale firewall using a secure file transfer 
program. Identifiable data (including the code key) will be destroyed as soon as permitted by 
law.  All information will be stored on a password protected and encrypted computer. 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The We are applying for a Certificate of Confidentiality from the National Institutes of 
Health. Once it is obtained, the researchers with this Certificate, may not disclose or use 
information, documents, or biospecimens that may identify you in any federal, state, or local 
civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as 
evidence, for example, if there is a court subpoena, unless you have consented for this use. 
Information, documents, or biospecimens protected by this Certificate cannot be disclosed to 
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Yale University
Page 4 of 4
anyone else who is not connected with the research except, if there is a federal, state, or local law 
that requires disclosure (such as to report child abuse or communicable diseases but not for 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings); if you 
have consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. The Certificate 
of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law 
of child abuse and neglect, elder abuse or neglect, or harm to self or others.
Please remember that while we (the researchers) will keep your information confidential and will 
remind all participants that what is said in the group should not be repeated outside of the group, 
we have no control over what happens outside of the group. You are reminded to not share 
anything you would not want repeated outside of this group. Also, as a peer moderator your are 
agreeing not to repeat anything you hear during the group outside of the group, with the 
following exceptions:
1. Study related supervision with designated supervisors
2. If a group participant reports significant emotional distress, passive or active suicidal 
ideation thoughts of hurting someone else during the study protocol you will alert the PI 
via phone and e-mail within 30 minutes of the conclusion of the session when the 
participant expressed or the peer specialist identified distress. 
Participation in this study is completely voluntary. You are free to decline to participate, to end 
participation at any time for any reason, or to refuse to answer any individual question without 
penalty. Your decision whether or not to participate in this study will not affect your relationship 
with Yale University or MaleSurvivor.
If you have any questions about this study, you may contact the principal investigator, Joan 
Cook, Ph.D., Yale University, Department of Psychiatrym300 George Street Suite 901, New 
Haven, CT 06511 or via phone at (203) 856-2782. 
If you would like to talk with someone other than the researchers to discuss problems or 
concerns, to discuss situations in the event that a member of the research team is not available, or 
to discuss your rights as a research participant, you may contact the Yale University Human 
Subjects Committee, 203-785-4688, human.subjects@yale.edu. Additional information is 
available at https://your.yale.edu/research-support/human-research/research-participants/rights-
research-participant
By clicking “accept” below, you are agreeing to participate in this study.
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Yale University 
Page 1 of 5
 Adult Consent for Participation in a Research Project  
200 FR 2 (2017-1)
Study Title: Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Investigator: Joan M. Cook, Ph.D.
Funding Source: Patient Centered Outcomes Research Institute (PCORI)
HSC #: 2000024842
Research Study Summary:
We are asking you to join a research study. The purpose of this research study is to examine how different types 
of online peer support can help male survivors reduce their emotional struggles. Study activities will include a 
confidential phone interview with a member of the study team asking questions about your emotional well-
being, completion of several online questionnaires, and participation in one of two online discussion groups, led 
by peer moderators (men who have had similar lived experiences as you). Your involvement will require 30-40 
minutes for the phone interview, 30 minutes to complete the online questionnaires, and participation in the 
online groups will take 1.5 hours weekly for 6 consecutive weeks. There are no known or anticipated risks 
associated with this study. However, some questions or discussion online may make you uncomfortable.
The study may have no benefits to you. By participating in this research study, you are contributing towards the 
advancement of knowledge on trauma treatment and may benefit those who experience sexual assault at some 
time in the future. Taking part in this study is your choice. You can choose to take part, or you can choose not to 
take part in this study. You also can change your mind at any time. Whatever choice you make will not have 
any effect on your relationship with Yale University. If you are interested in learning more about the study, 
please continue reading, or have someone read to you, the rest of this document. Please ask the study staff 
questions about anything you do not understand. Once you understand the study, we will ask you if you wish to 
participate; if so, you will have to sign this form.
Purpose:
You are invited to participate in a research study designed to examine how different types of online peer support 
can help male survivors reduce their emotional struggles and feel more comfortable seeking help for issues 
related to their emotional health. You have been asked to take part because you are: a) 18 years of age or older; 
b) English-speaking; c) reporting a history of sexual abuse or assault at some point in your lifetime; d) identify 
as male; e) identify as at least one of the following: gay, bisexual, transgender, attracted to men, or have sex 
with men; f) experiencing emotional distress; and g) have not received any psychotherapy or formal mental 
health counseling in the past 60 days. We expect to enroll approximately 345 people in this research study, 
which will last approximately 3 years. 
Procedures:
If you agree to take part in this study, your participation will involve a confidential phone interview with a 
member of the study team asking questions about your emotional well-being, and completion of several online 
questionnaires to determine eligibility for the study. Participation in the study will involve completion of a 6-
week peer-led online group and follow-up questionnaires. The questionnaires and interview will ask you basic 
demographic questions about your age, ethnicity, gender identification, and sexual orientation identification. 
We will also ask you more personal questions about the nature of your sexual abuse and a few short questions 
asking symptoms of anxiety, depression, and posttraumatic stress. You’ll also be asked to complete some 
questionnaires (all online) that ask about different emotional health symptoms you may be experiencing. 
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Yale University 
Page 2 of 5
After completion of the questionnaires, you will be randomly assigned to participate in either of two online 
discussion groups. Both groups will be led by peer moderators (men who have had similar lived experiences as 
you). The groups will last for 1.5 hours and meet weekly, online, for 6 consecutive weeks.
At the end of the 6-week group, and at two other times (two and four months post-group) we’ll again ask you to 
complete online questionnaires about your emotional well-being. Finally, we will ask a small subset of 
participants (60 people) to complete a telephone interview following the completion of the treatment to get your 
feedback about the treatment as well as preferences for potential future mental health treatment.
We anticipate that your involvement in the entire study will require approximately 15-20 hours of your time 
spread across approximately 6 months.  You will receive $20 dollars for each wave of questionnaires you 
complete (before the start of the treatment, immediately following the end of the 6-week treatment, at two 
months follow-up, and at four months follow-up) for a total possible amount of $80. If you participate in the 
final telephone interview you will receive an additional $30. 
Participation in this research study requires your permission to be audio-recorded. Your name or other 
identifiers will not be associated with the audio file. Audio-recordings will be used to measure the peer 
moderators’ adherence to the interventions well as to provide us more detailed data on the therapeutic process 
(e.g., what interventions have the most positive impact and which do not). By signing this consent you are also 
agreeing to audio-recording of the intervention sessions. The audio-recordings will be sent outside of Yale for 
transcription. A confidentiality agreement will be executed with the transcription company prior to transfer of 
any files. The transcriptionist will de-identify and names (including nicknames) recorded in the audio-file with 
the pseudonym “Moderator” and “Participant”. To delineate between the persons the transcriptionist will label 
each individual with a number e.g. “Participant 1” or “Participant 5”. Audio-files will be sent to the professional 
transcriptionist within one week of the completed recordings. Audio-files will be destroyed as soon as the 
transcribed files are received back from the professional transcriptionist and reviewed by the investigative team 
to ensure completeness. The review of the transcribed files will occur within one week of receiving the files 
from the transcriptionist.
A description of this research study is available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this Web site at any time.
Risks and Benefits:
There are no known or anticipated risks associated with this study.  However, some questions may make you 
uncomfortable and it is possible that you may become upset or experience increased anxiety talking about some 
of these difficult past personal experiences. There is also the possible risk of loss of confidentiality.  Every 
effort will be made to keep your information confidential; however, this cannot be guaranteed. If you are 
deemed to be at high risk of suicide during the confidential phone interview with a member of the study team, 
one of the licensed clinical psychologists on the study team will follow up with you via a separate phone call to 
determine your risk and to provide you with tailored resources and referrals for immediate help.  You may 
withdraw your consent for participation in this research study at any time by writing to the Principal 
Investigator:
Joan Cook, Ph.D.
Yale University
Department of Psychiatry
300 George Street, Suite 901
APPROVED BY THE YALE UNIVERSITY IRB 2/7/2021

APPROVED BY THE YALE UNIVERSITY IRB 2/7/2021
Yale University 
Page 3 of 5
New Haven, CT 06511
theconnectstudy@yale.edu
By participating in this research project you are contributing towards the care, treatment and well-being of 
countless numbers of men (and women) who have experienced sexual abuse or assault across their lifespan. In 
addition, participation contributes towards the advancement of behavioral science and may benefit those who 
experience sexual assault at some time in the future.
Confidentiality:
All of your responses will be held in confidence.  Only the researchers involved in this study and those 
responsible for research oversight (such as representatives of the Yale University Human Research Protection 
Program, and the Yale University Human Subjects Committee, and offices responsible for fiscal monitoring) 
will have access to any information that could identify you. We will ask you to identify yourself in groups using 
a nickname or only your first name (not to include surname/last name). We will use a coding system to 
randomly assign a number associated with any information we get from you. Only the investigative team (Dr. 
Cook, Dr. Amy Ellis, Dr. Vanessa Simiola and the project coordinator) will have access to the key. This means 
that identifiable data such as your name, telephone number and e-mail address will be shared amongst the 
investigative staff. Drs. Ellis and Simiola are not affiliated with Yale University. They will conduct portions of 
this research study including the screening interview and post-intervention telephone interview from their 
respective organizations. Drs. Ellis and Simiola are associated with Nova Southeastern University and Kaiser 
Permanente, Hawaii, respectively. Any exchange of protected health information (such as your name, telephone 
number, or e-mail address) or coded data will take place behind the Yale firewall using a secure file transfer 
program. Identifiable data (including the code key) will be destroyed as soon as permitted by law. All 
information will be stored on a password protected and encrypted computer. 
Please remember that while we (the researchers) will keep your information confidential and will remind all 
participants that what is said in the group should not be repeated outside of the group, we have no control over 
what happens outside of the intervention groups. You are reminded to not share anything you would not want 
repeated outside of this group. Although all participants in the group must agree to not disclose any of the 
information discussed within the group, ultimately, we cannot guarantee that all participants will maintain this 
confidentiality. You must be aware that there is the possibility that personal information may be discussed 
outside of the confines of the study.
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The 
researchers with this Certificate may not disclose or use information, documents, or biospecimens that may 
identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or 
proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this 
use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else 
who is not connected with the research except, if there is a federal, state, or local law that requires disclosure 
(such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings); if you have consented to the disclosure, including for your 
medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting 
research subjects. The Certificate of Confidentiality will not be used to prevent disclosure as required by 
federal, state, or local law of child abuse and neglect, elder abuse or neglect, or harm to self or others.
Note, however, that your records may be reviewed by those responsible for the proper conduct of research such 
as the Yale University Human Research Protection Program, Yale University Human Subjects Committee or 
representatives of the U.S. Department of Health and Human Services or the sponsor (Patient Centered 
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Page 4 of 5
Outcomes Research Institute). The information about your health that will be collected in this study includes: 
Name, date of birth, telephone number, and e-mail address. We will also collect information about your emotional 
health and well-being.
Information may be re-disclosed if the recipients are not required by law to protect the privacy of the 
information.  At the conclusions of this study, any identifying information related to your research participation 
will be destroyed, rendering the data anonymous. 
By signing this form, you authorize the use and/or disclosure of the information described above for this 
research study.  The purpose for the uses and disclosures you are authorizing is to ensure that the information 
relating to this research is available to all parties who may need it for research purposes.
This authorization to use and disclose your health information collected during your participation in this study 
will never expire.
Voluntary Participation:
Your participation in this study is voluntary.  You are free to decline to participate, to end your participation at 
any time for any reason, or to refuse to answer any individual question without penalty. Your decision whether 
to participate or not will have no effect on your relationship with Yale University or MaleSurvivor.
 
You may withdraw or take away your permission to use and disclose your health information at any time.
 
If you are assigned to a peer-led online group, you may stop your participation in the group at any time. You 
can do this by informing the study staff or by not attending groups. If you stop your participation in groups, you 
will be asked to complete the remaining study assessments, but again, this is voluntary, and you will not be 
penalized for declining.
 
You may also withdraw your permission to be in this study by telling the study staff. If you withdraw your 
permission, you will not be able to participate in this study. When you withdraw your permission, no new health 
information identifying you will be gathered after that date.  Information that has already been gathered may 
still be used and given to others until the end of the research study, as necessary to insure the integrity of the 
study and/or study oversight. 
Questions:
If you have any questions about this study, you may contact the principal investigator, Joan Cook, Ph.D., Yale 
University, Department of Psychiatry, 300 George Street Suite 901, New Haven, CT 06511, via phone at (203) 
856-2782 or email our study team at theconnectstudy@yale.edu. 
If, after you have signed this form, you have any questions about your privacy rights, please contact the Yale 
Privacy Officer at 203-432-5919.
If you would like to talk with someone other than the researchers to discuss problems or concerns, to discuss 
situations in the event that a member of the research team is not available, or to discuss your rights as a research 
participant, you may contact the Yale University Human Subjects Committee, 203-785-4688, 
human.subjects@yale.edu. Additional information is available at http://your.yale.edu/research-support/human-
research/research-participants
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Page 5 of 5
Agreement to Participate:
I have read the above information, have had the opportunity to have any questions about this study answered 
and agree to participate in this study.
By signing below, you are agreeing to participate in this study.
APPROVED BY THE YALE UNIVERSITY IRB 2/7/2021

Analysis Plan 
 
To assess the success of randomization, baseline demographic and clinical characteristics, the 
two randomized groups were compared using chi-square tests for categorical variables and t-tests or 
Mann-Whitney tests for continuous variables. Data analyses were conducted on the intent-to-treat 
sample. All variables were evaluated for their distributional properties and data processing errors. 
Robust estimators were used to address non-normal data.  
Variables were assessed for amount and pattern of missing data. Full information maximum 
likelihood estimation was used in subsequent analyses to address missingness. Inclusion of informative 
variables were included as needed. Analyses were conducted in SPSS 28.0 (IBM, 2021). For outcome 
analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures 
outcome variable, nested within participants. Baseline demographic, clinical variables, and sexual abuse 
experiences were included as time-invariant covariates (between participants), as was treatment group. 
Thus, for each outcome, the primary analysis included all observations nested in persons and cohorts, 
controlling for baseline clinical and demographic variables.  
Before examining the potential role of any mediators, LMM was conducted to determine any 
main or interaction effects condition and/or time may have had on these mediators as outcomes. To 
assess heterogeneity of treatment effects, the potential moderating impact that participant demographic 
variables and significantly correlated covariates had on the relationship between condition and primary 
outcomes was examined by including a moderator x condition interaction term in models.  
Inclusion of demographic and clinical variables in mixed models allowed for testing of 
heterogeneity of treatment effects (HTE), with adjusted p-values. Specifically, in addition to the primary 
analyses, subsequent supplementary analyses tested potential moderators by including a treatment group 
X demographic interaction (race, comorbidity, and education) as these are the most likely candidates for 
HTE effects. Potential moderating effects of baseline values of minority stress, conformity to masculine 
norms and barriers to help seeking were also examined using SPSS PROCESS, which provides 
estimates of conditional effects of focal predictor (treatment condition) at different values of the 
moderator.