Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults
Phase: NA
Conditions: Depression, Suicidality, Substance Abuse, HIV, Minority Stress
Sponsor: Yale University

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NCT03751020  
 
Title of Research Project: Development and preliminary trial of a brief, portable health 
intervention for rural sexual minority emerging adults 
 
Protocol Date 4.2.2019 
 
 

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YALE UNIVERSITY IRBs 
 
                    Application for Full or Expedited IRB Review of a Study  
Involving Human Participants in 
Social or Behavioral Science or Educational Research 
 
100 FR 28 (2015-1)  
 
NOTE: IF YOUR STUDY INVOLVES: 
 
Genetic Testing 
 
Blood Draws  
Do not use this form. Use the biomedical HIC application 
MRI scans 
 
Secondary analysis of data 
  Use the Request for Approval of Secondary Analysis of 
Data 
 
 
 
Activities that may qualify as exempt research         Use the Request for Exemption form 
(which includes a decision tree to determine whether or not your study qualifies as exempt). 
 
 
SECTION I: ADMINISTRATIVE INFORMATION 
 
Title of Research Project: Development and preliminary trial of a brief, portable health intervention for 
rural sexual minority emerging adults  
 
Principal Investigator: John Pachankis, PhD 
 
Yale Academic Appointment: Associate Professor of 
Public Health 
 
Department: Chronic Disease Epidemiology, Social & Behavioral Sciences 
Campus Address: 60 College Street (LEPH), Rm 316 
 
Campus Phone: 203-785-3710 
 
 
E-mail: john.pachankis@yale.edu 
Protocol Correspondent Name & Address (if different than PI): 
  
Campus Phone:  
 
E-mail:  
 
 
 
Faculty Advisor: (required if PI is a student, 
resident, fellow or other trainee)           
 NA 
 
Yale Academic Appointment: 
 
Campus Address:  
 
Campus Phone:  
 
 
E-mail:  

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Investigator Interests: 
Does the principal investigator, or do any research personnel who are responsible for the design, 
conduct or reporting of this project or any of their family members (spouse or dependent child) 
have an incentive or interest, financial or otherwise, that may affect the protection of the human 
participants involved in this project, the scientific objectivity of the research or its integrity? Note: 
The Principal Investigator (Project Director), upon consideration of the individual’s role and 
degree of independence in carrying out the work, will determine who is responsible for the design, 
conduct, or reporting of the research.  
See Disclosures and Management of Personal Interests in Human Research 
http://www.yale.edu/hrpp/policies/index.html#COI  
  Yes  
  No X 
 
Do you or does anyone on the research team who is determined by you to be responsible for the 
design, conduct or reporting of this research have any patent (sole right to make, use or sell an 
invention) or copyright (exclusive rights to an original work) interests related to this research 
protocol? 
  Yes  
  No  X 
 
 
 
If yes to either question above, list names of the investigator or responsible person: 
 
 
 
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale 
University individuals who are responsible for the design, conduct or reporting of research must 
have a current financial disclosure form on file with the University’s Conflict of Interest Office. 
Yale New Haven Hospital personnel who are listed as co-investigators on a protocol with a Yale 
University Principal Investigator must also have a current financial disclosure form on file with 
the University’s Conflict of Interest Office. If this has not been done, the individual(s) should 
follow this link to the COI Office Website to complete the form:  http://www.yale.edu/coi/   
 
NOTE: The requirement for maintaining a current disclosure form on file with the University’s 
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital 
personnel.  Whether or not they are required to maintain a disclosure form with the 
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise 
responsible by the PI who are listed on the protocol are required to disclose to the PI any 
interests that are specific to this protocol. 
 
SECTION II: GENERAL INFORMATION 
 
 
1. Probable Duration of Project: State the expected duration of the project, including all 
follow-up and data analysis activities.  
 
36 months: Expected start date: 04/01/2016; Expected End Date: 06/31/2019.  
 

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2. Study location: State where the study will take place and in what setting. 
 If international, complete and submit International checklist (http://www.yale.edu/hrpp/forms-
templates/behavioral.html) 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.    
 
This first part of this study consists of focus groups and interviews that will be conducted in-
person and by telephone and an intervention that will be conducted online with participants 
recruited from South and Central Appalachia (Southern West Virginia, Eastern Kentucky, 
Western Virginia, Eastern Tennessee). In-person focus groups will be conducted at East 
Tennessee State University in Dr. Williams’ research office in the Department of 
Psychology.   
 
During the second part of this study, we will test a writing intervention online.  Data analysis 
will occur at Yale University in New Haven, CT (PI John Pachankis), College of the Holy 
Cross in Worcester, MA (PI Stephanie Chaudoir), and East Tennessee State University in 
Johnson City, TN (Subaward PI Stacey Williams). 
 
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 
 
 
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING 
 
Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply. 
Provide information regarding the external funding source.  This information should include 
identification of the PI on the award, agency/sponsor, the funding mechanism (grant or 
contract), and whether the award is pending or has been awarded. Provide the Yale institutional 
proposal number and Agency name (if grant-funded).  If the funding source associated with a 
protocol is “pending” at the time of the protocol submission to the IRB (as is the case for most 
NIH submissions), the PI should note “Pending” in the appropriate section of the protocol 
application, provide the Yale institutional proposal number and Agency name (if grant-funded) 
and further note that University (departmental) funds support the research (until such time that 
an award is made).   

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PI of grant (if 
applicable) 
Title of Grant (if 
applicable) 
Name of Funding Source (i.e. 
Dept name or Fellowship) 
Funding type 
Funding Mechanism 
John Pachankis, 
PhD 
Development and 
preliminary trial of a 
brief, portable health 
intervention for rural 
sexual minority 
emerging adults  
NIH / NICHD 
Exploratory/Developmental 
Research Grant Program: 
R21 MH113860-01A1 
(pending) 
Yale 
fellowship 
Yale 
department 
No 
funding 
(student 
projects, etc.) 
  Federal 
  State 
  Non Profit 
  Industry 
  Other For 
Profit  
 
  Other 
 
Grant: NICHD R21 
MH113860-01A1 
(pending)        
Contract#  
Contract Pending 
  Investigator/Department 
Initiated 
  Sponsor Initiated 
  Other, Specify: 
 
 
Note – IRB fees are charged for projects funded by Industry or Other For-Profit Sponsors. Provide the name 
and Address of the Sponsor Representatives to whom the invoice should be sent.   The PI’s home 
department will be billed if this information is not provided.  N/A 
  
1. Research Team:  List all members of the research team. Indicate under the affiliation column whether 
the investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff 
from a collaborating institution, or are not formally affiliated with any institution. ALL members of the 
research team MUST complete Human Subject Protection Training (HSPT) and Health Insurance 
Portability and Accountability Act (HIPAA) training (if applicable) before they may be listed on 
the protocol.  See NOTE below. 

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Name 
Affiliation: Yale/Other 
Institution (Identify) 
 
Net ID 
Principal Investigator  
John Pachankis, PhD 
Yale School of Public 
Health 
Jep69 
Role: Co-PI 
Stephanie Chaudoir, PhD 
College of the Holy 
Cross 
 
Role: Co-PI 
Stacey Williams, PhD 
East Tennessee State 
University 
 
Role: Project Assistant 
Katie Wang, PhD 
Yale School of Public 
Health 
Pw255 
Role: Project Assistant 
Roxanne Winston, MPH 
Yale School of Public 
Health 
Rw527 
Role: Project assistant 
Sarah Job 
ETSU 
 
Role: Project assistant 
Abbey Mann, PhD 
ETSU 
 
Role: Project assistant 
TJ Sullivan 
Yale School of Public 
Health 
Tjs66 
Role: Project assistant 
Erin McConocha 
Yale School of Public 
Health 
 
Role: Project assistant 
Nicholas Fasanello 
ETSU 
 
Role: Project assistant 
Samantha Stone 
ETSU 
 
 
Role: Project assistant 
Emily Clark 
ETSU 
 
Role: Project assistant 
Cal Brisbin 
Yale School of Public 
Health 
 
Role: Project Assistant 
Charles Burton, PhD 
Yale School of Public 
Health 
 
Role: Project Assistant 
Ingrid Solano, MA 
 
Ias26 
Role: Project Assistant 
Tenille Taggard, MA 
 
TT443 
Role: Project Assistant 
Craig Rodriguez-Seijas, MA 
 
Cr672 
Role: Project Assistant 
Colin Kimberlin 
 
Ck624 
Role: Project Assistant  
Ann Mondi 
 
 
Role: Project Assistant 
Sarah Barr 
 
 
Role: Project Assistant 
Michael Andre 
 
 

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NOTE: The HSC will remove from the protocol any personnel who have not completed required training. A 
request to change study personnel will need to be submitted when training is completed. 
 
 
 
SECTION IV: RESEARCH PLAN 
 
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.  
 
Aim 1 (Conduct elicitation research, phase 1):  
We will conduct focus groups and structured interviews with 20 rural lesbian, gay, and 
bisexual (LGB) emerging adults and LGB community leaders in order to create appealing, 
culturally resonant intervention materials for rural Appalachian LGB emerging adults (aged 
18-29 years). 
 
Aim 2: (Use elicitation research findings to adapt interventions, phase 2): 
We will interview 10 LGB emerging adults and LGB community leaders to further refine 
Expressive Writing (EW), Self-Affirmation (SA), and Control (C) online writing 
interventions for use among LGB emerging adults in rural Appalachia. 
 
Aim 3: (Intervention feasibility, acceptability, and preliminary efficacy testing, phase 3): 
We will examine the feasibility, appeal, and preliminary efficacy of EW and SA 
interventions relative to control. The primary outcomes of interest will include depressive 
symptoms, suicidality, substance use, and HIV sexual risk behaviors at the 3-month post-
intervention assessment.  
 
 
 
 
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.  
 
Lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) report significantly greater depression,  
suicidality, substance use, and HIV risk behaviors than heterosexuals (1,2). These disparities are 
magnified among LGB emerging adults who live in rural or nonurban areas in the US (3). Indeed, rural 
LGB emerging adults are more likely to binge drink, use illegal drugs, and report depression than their 
urban LGB peers (4,5). These disparities are particularly severe in Appalachia, a cultural context 
characterized by negative attitudes and interpersonal discrimination towards LGBs (6,7), mental and 
physical health outcomes among the poorest in the nation (8), and limited access to mental and physical 
health providers (9).  
 
This proposal is designed to adapt and test the feasibility and efficacy of online Expressive Writing 
(EW) and Self-Affirmation (SA) writing interventions that offer two low-cost, portable vehicles capable 
of mitigating mental health and behavioral risk disparities among Appalachian LGB emerging adults. 
 
1. Expressive Writing (EW) interventions prompt individuals to write about personally stressful 
events, enabling cognitive-affective stress processing. Our own pilot work and other recent 

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studies demonstrate that EW reduces depression (10) and alcohol and illicit drug use (11, 12) 
and can, in combination with other techniques, reduce HIV sexual risk (13) among urban 
LGB emerging adults.  
2. Self-Affirmation (SA) writing interventions prompt individuals to write advice to a 
(hypothetical) and similarly stigmatized person regarding how best to cope with stigma-
related stress. By affirming one’s own stigmatized identity through the process of helping 
another similarly stigmatized person (14, 15), SA has been shown to reduce alcohol use (11) 
and stress hormones (e.g., cortisol) (16,17) closely associated with depression among 
emerging adults. 
 
In this exploratory research project, we propose to adapt and test the comparative efficacy of these brief, 
low-cost, and portable interventions to improve mental health and health risk behaviors among 
Appalachian LGB emerging adults, one of the most vulnerable populations in the U.S. Moreover, we 
apply Minority Stress Theory (18) to identify and test two plausible mechanisms through which EW and 
SA might mitigate mental and behavioral health disparities faced by LGB individuals.  
 
We propose that sexual minority stressors increase psychobiological stress and deplete emotional and 
behavioral self-regulation, thereby contributing to LGB disparities. Previous research has speculated 
(but not tested) that EW and SA interventions are effective because they reduce psychobiological stress 
and improve emotional and behavioral self-regulation, respectively. Therefore, in a novel test of these 
hypotheses, our pilot study will directly examine psychobiological stress and self-regulation as the 
putative mechanisms by which EW and SA interventions are efficacious and by which LGB disparities 
are generated. 
 
 
 
 
To accomplish these research goals, this project will pursue the following aims: 
 
Specific Aim 1: Conduct elicitation research with 20 Appalachian LGB emerging adults and LGB 
community leaders in order to develop effective intervention materials and stress targets. 
Participants will be asked to describe the type and frequency of sexual minority stressors faced by 
LGB emerging adults in their region (to create EW prompts and SA vignettes) and strategies to 
enhance the LGB-affirmative look-and-feel of the Phase 3 online platform.  
 
Specific Aim 2: Present Specific Aim 1 results to 10 Appalachian LGB emerging adults and LGB 
community leaders to refine the EW prompts and SA vignettes and the LGB-affirmative, culturally 
relevant look-and-feel of the online platform. Identify, with these leaders, the most effective venues 
and materials for participant recruitment and retention, and identify the most effective modalities for 
future intervention dissemination. 
 
Specific Aim 3: Pilot test feasibility and efficacy of writing interventions. 108 Appalachian LGB 
emerging adults will be randomized to complete one of three writing interventions (EW, SA, 
Control). They will be asked to complete outcome measures (depressive symptoms, suicidality, use 
of alcohol and illicit drugs, HIV risk behavior) and measures of proposed mediators (self-reported 
and biological stress, behavioral and emotional self-regulation) and moderators (e.g., social support, 

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identity centrality) at baseline, post-intervention, and three-month follow-up. In addition, structured 
interviews with 15 intervention participants will be used to refine study procedures as we scale up 
this intervention for a future RCT. Primary analyses will determine efficacy; secondary analyses will 
determine the moderating role of social support, gender, and other psychosocial factors (e.g., 
baseline risk) and estimate the effect sizes of the mediators of intervention efficacy for use in a 
subsequent RCT to determine the long-term efficacy and mechanisms of these interventions. 
 
Despite evidence indicating that mental and physical health disparities are most severe among LGB 
emerging adults living in rural areas of the U.S., there are currently no evidence-based psychological 
interventions designed to mitigate sexual minority stress effects among this population (19). The 
proposed culturally-relevant, theory-based interventions are poised to reduce this gap and, therefore, 
address one of the most pressing public health goals of the U.S. Department of Health and Human 
Services (20, 21).  
 
References 
1. Marshal, M. P. et al. Sexual orientation and adolescent substance use: a meta-analysis and 
methodological review. Addict. Abingdon Engl. 103, 546–556 (2008). 
2. Marshal, M. P. et al. Suicidality and depression disparities between sexual minority and 
heterosexual youth: a meta-analytic review. J. Adolesc. Health Off. Publ. Soc. Adolesc. Med. 49, 
115–123 (2011). 
3. Ingram, D. D. & Franco, S. J. National Center for Health Statistics urban-rural classification 
scheme for counties. (2012). at <http://www.cdc.gov/nchs/data/series/sr_02/sr02_154.pdf> 
4. Poon, C. S. & Saewyc, E. M. Out Yonder: Sexual-Minority Adolescents in Rural Communities in 
British Columbia. Am. J. Public Health 99, 118–124 (2009). 
5. Galliher, R. V., Rostosky, S. S. & Hughes, H. K. School Belonging, Self-Esteem, and Depressive 
Symptoms in Adolescents: An Examination of Sex, Sexual Attraction Status, and Urbanicity. J. 
Youth Adolesc. 33, 235–245 (2004). 
6. McVeigh, R. & Diaz, M.-E. Voting to Ban Same-Sex Marriage: Interests, Values, and 
Communities. Am. Sociol. Rev. 74, 891–915 (2009). 
7. Swank, E., Fahs, B. & Frost, D. M. Region, Social Identities, and Disclosure Practices as 
Predictors of Heterosexist Discrimination Against Sexual Minorities in the United States. Sociol. 
Inq. 83, 238–258 (2013). 
8. United Health Foundation. America’s Health Rankings. (2014). at 
<http://www.americashealthrankings.org/TN/2012> 
9. Health Resources and Services Administration. Find Shortage Areas: HPSA by State & County. 
(2014). at <http://hpsafind.hrsa.gov/> 
10. Pachankis, J. E. & Goldfried, M. R. Expressive writing for gay-related stress: Psychosocial 
benefits and mechanisms underlying improvement. J. Consult. Clin. Psychol. 78, 98–110 (2010). 
11. Armitage, C. J., Rowe, R., Arden, M. A. & Harris, P. R. A brief psychological intervention that 
reduces adolescent alcohol consumption. J. Consult. Clin. Psychol. 82, 546–550 (2014). 
12. Carrico, A. W. et al. Pilot Trial of an Expressive Writing Intervention With HIV-Positive 
Methamphetamine-Using Men Who Have Sex With Men. Psychol. Addict. Behav. (2014). 
doi:10.1037/adb0000031 
13. Lelutiu-Weinberger, C. et al. Feasibility, Acceptability, and Preliminary Efficacy of a Live-Chat 
Social Media Intervention to Reduce HIV Risk Among Young Men Who Have Sex With Men. 
AIDS Behav. (2014). doi:10.1007/s10461-014-0911-z 

Page 10 of 30 
 
14. Hall, C. C., Zhao, J. & Shafir, E. Self-Affirmation Among the Poor Cognitive and Behavioral 
Implications. Psychol. Sci. 0956797613510949 (2013). doi:10.1177/0956797613510949 
15. Sherman, D. K. & Cohen, G. L. in Advances in Experimental Social Psychology (ed. Mark P. 
Zanna) Volume 38, 183–242 (Academic Press, 2006). 
16. Creswell, J. D. et al. Affirmation of Personal Values Buffers Neuroendocrine and Psychological 
Stress Responses. Psychol. Sci. 16, 846–851 (2005). 
17. Sherman, D. K., Bunyan, D. P., Creswell, J. D. & Jaremka, L. M. Psychological vulnerability and 
stress: The effects of self-affirmation on sympathetic nervous system responses to naturalistic 
stressors. Health Psychol. 28, 554–562 (2009). 
18. Meyer, I. H. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: 
Conceptual issues and research evidence. Psychol. Bull. 129, 674–697 (2003). 
19. Chaudoir, S. R., Wang, K. & Pachankis, J. E. What reduces the effect of sexual minority stress on 
health disparities?: A review of the intervention ‘toolkit’. J. Soc. Issues (under review). 
20. National Institute of Drug Abuse. Strategic Plan. (2010). at <www.drugabuse.gov> 
21. U.S. Department of Health and Human Services. Healthy People 2020. (2010). at 
<http://www.healthypeople.gov/2020/TopicsObjectives2020/pdfs/HP2020_brochure.pdf> 
 
 
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.  
 
We will conduct focus groups with 20 Appalachian LGB emerging adults and LGB 
community leaders to create culturally relevant intervention materials that can be feasibly 
implemented in rural contexts. We will utilize elicitation research findings from Aim 1 to 
adapt Expressive Writing (EW), Self-Affirmation (SA, and Control (C) online writing 
interventions for use among rural LGB emerging adults in rural Appalachia. Interviews with 
10 Appalachian LGB emerging adults and LGB community stakeholders will additionally 
inform the intervention content as well as recruitment strategies. Finally, we will examine 
the efficacy of EW and SA relative to C. The primary outcomes of interest will include 
depressive symptoms, suicidality, substance use, and HIV risk behaviors at 3-month post-
intervention.  
 
PHASE/AIM 1: 
For phase 1, we will recruit 20 rural LGB emerging adults (aged 18-29) and LGB community 
leaders who (i) self-identify as LGB, and (ii) currently live in South or Central Appalachia. 
We will recruit participants for a focus group of up to five participants through postings and 
ads on geo-targeted websites (e.g., Craigslist, Facebook), bulletin boards and listservs at 
regional colleges and universities (e.g., gay-straight alliance [GSA] listserv); and in-person 
announcement and flyers at local community centers, bars, and the GSA of area schools. 
After emailing/calling our research team, potential participants will speak with a trained 
research assistant (RA) who will explain the study purpose and procedures, verify eligibility, 
and assess consent. Age eligibility will be verified by photo ID, requiring each participant to 
email a snapshot of themselves holding their photo ID (note: age criterion applies only to the 
emerging adults, not to the LGB community leaders). Participants will use their phone to 

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email a photo of their IDs and these emails will be securely on Yale Secure box after received 
and then the record of the photo will be deleted from research staff emails after the photo is 
verified and stored. In our experience, an LGB sexual orientation identity is difficult to fake, 
especially in interviews such as ours that assess LGB cultural knowledge and contexts 
specific to LGB individuals. 
 
We will aim to conduct four focus groups of five participants each (20 total participants). 
Two of the focus groups will be comprised of LGB emerging adults and two of the focus 
groups will be comprised of the LGB community leaders (LGB community leaders have 
already indicated their support for this Phase with letters of support on file for NIH funding 
application). These community leaders live in the targeted geographic region and are 
affiliated with an online- or community-based organization that provides support services to 
Appalachian LGB emerging adults. Community leaders were recruited to advise this study 
through in-person invitations to local LGB advocates and health providers in Dr. William’s 
professional network (e.g., ETSU GSA, Northeast State GSA, PFLAG Tri-Cities, Tennessee 
Equality Project).  
 
If Phase 1 eligible participants are not available to come in for an in-person focus group, they 
will have the option to do a phone interview for Phase 1 or, alternatively, will be invited to 
participate in Phase 2 or Phase 3. 
 
Drs. Williams, Chaudoir, and Pachankis will conduct the focus groups, with the aid of 
research assistants. Participants will be presented with information about the preliminary 
goals of the intervention and will be asked to describe the type and frequency of sexual 
minority stressors faced by LGB emerging adults in their region (to create EW prompts and 
SA vignettes) and strategies to enhance the LGB-affirmative look-and-feel of the Phase 3 
online writing session. Phase 1 participants will not be eligible for Phase 3, however five of 
the 10 LGB community leaders will be invited back to participate in Phase 2. 
 
All focus groups will be audiotaped and transcribed by a trained research assistant or 
professional transcription company. Drs. Williams, Chaudoir, and Pachankis will use 
thematic coding to analyze data and identify overarching assertions for modifying the SA 
intervention using qualitative data analysis software (e.g., NVivo, Atlas.ti). Data will be 
indexed and coded using open and axial coding. Axial coding will address research questions 
guiding our interview, while open coding will identify themes emerging from participants’ 
perspectives. The investigative team will review Phase 1 codes to create EW prompts and 
SA intervention vignettes, and ensure LGB-affirmative look-and-feel of the online 
intervention materials and platform. 
 
PHASE/AIM 2: 
We will conduct 10 in-person interviews with LGB emerging adults and LGB community 
leaders to further refine Expressive Writing (EW), Self-Affirmation (SA), and Control (C) 
online writing interventions for use among rural LGB emerging adults in rural Appalachia. 
 
After incorporating Phase 1 feedback, the intervention materials will be presented to five 
LGB emerging adults (not repeat participants from Phase 1) and five LGB community 

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leaders (repeat participants from Phase 2) (LGB community leaders have already indicated 
their support for this Phase with letters of support on file for NIH funding application), in 
order to further gather, through interviews with Drs. Williams, Chaudoir, and Pachankis, 
adaptations that appeal to the community for whom this intervention will ultimately be 
disseminated. These community members and leaders will also describe the acceptability of 
the intervention dosage and the most effective modalities for future intervention 
dissemination (see Appendix). These community leaders meet the eligibility criteria and are 
affiliated with an online- or community-based organization that provides support services to 
Appalachian LGB emerging adults. Community leaders were recruited to advise this study 
through in-person invitations to local LGB advocates and health providers in Dr. William’s 
professional network (e.g., ETSU GSA, Northeast State GSA, PFLAG Tri-Cities, Tennessee 
Equality Project). Phase 2 enrollment and interview materials will follow those described for 
Phase 1 (see Appendix).   
 
 
PHASE/AIM 3: 
We will recruit 108 Appalachian LGB emerging adults (36 per group) who (i) are aged 18-
29, (ii) self-identify as a sexual minority (e.g., lesbian, gay, bisexual, pansexual, queer), (iii) 
currently live in Eastern Tennessee counties of Washington, Sullivan, Carter, Unicoi, 
Greene, or Hawkins County, and (iv) have daily personal internet access. Participants will 
be recruited, screened, and consented for an online writing intervention using Phase 1 
strategies. Recruited individuals will be directed to complete a brief online screener gauging 
eligibility where they will consent to share their information with the research team. Those 
who consent to the online screener and meet the study eligibility criteria will then receive a 
call from a research team member who will share additional information about the study and 
gain consent for study participation. During the consent call, study staff will confirm 
participant age, contact information (such as phone number and address), and give 
participants the option to provide a secondary contact. After providing consent, participants 
will be emailed a link to complete an online baseline assessment (Study Task 1), then 
randomized to one of the three online writing interventions to be completed daily for three 
days starting the Monday of the following week (Study Task 2-Study Task 4). Participants 
will have up to two weeks to complete the three days of writing prompts. If the participant 
has not begun their first writing day (Study Task 2) within 24 hours of receiving the prompt 
than they will receive one email reminder per day for three days encouraging them to 
complete their writing prompt. If they still have not completed their writing prompt by the 
fifth day, then a research team member will try calling or texting the participant to remind 
them to complete the task. Upon completion of the first writing day (Study Task 2), the 
participant will have 24hrs to complete the second writing day (Study Task 3). If the 
participant does not complete the second writing day (Study Task 3) within 24 hours, then 
study staff will use the same email, text, and call reminder system as with writing day one 
(Study Task 2) to encourage them to complete writing day two (Study Task 3). The same 
communication and reminder protocol will be followed to encourage the participant to 
complete the third writing day (Study Task 4). Cumulatively, participants will have 14 days 
to complete the three writing prompts, but participants will not be invited to move on to the 
second writing prompt without first completing the prompt from writing day one, nor will 
they be prompted to complete the third writing task without submitting the second writing 
task. Seven days after completing their final writing task, or seven days after the close of the 

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two week writing window participants will be emailed a link to complete the post-
intervention survey (Study Task 5). 30 days after completion of the first survey, and 30 days 
after completing the 3-month online follow-up assessment survey, participants will be mailed 
materials to collect a hair sample in order to assay for cortisol. At 3 months after completion 
of the post-intervention survey, participants will receive and complete a follow-up 
assessment via online survey. Lastly, we will randomly select 15 participants from Phase 3 
for a follow up one-hour phone or internet-based interview where we will ask about 
participant experience with the writing sessions.   
 
Expressive Writing (EW) Intervention:  
In the Expressive Writing (EW) intervention, participants will be instructed to 
continually write for 20 minutes in a free-form manner about the most stressful or 
traumatic LGBT+ related event that they have encountered across three, ideally, 
consecutive days. The EW writing prompt will ask the participant to expressively 
write about their most personally stressful minority stress event. As part of the 
prompt, common examples facing Appalachian LGBT+ emerging adults will be 
provided based on Phase 1 and Phase 2 feedback.  
 
Self-Affirmation (SA) Intervention:  
The Self-Affirmation (SA) intervention will ask participants to read a brief 
description, over the course of 3 writing days, of a (hypothetical) LGBT+ youth who 
is facing stigma-related stress. Each day’s description will contain a different LGBT+ 
youth facing a different stigma-related stressor derived from Phase 1 and Phase 2 
interviews. Drawing on their personal experiences, participants will then be asked to 
write a letter for 20 minutes to advise the LGBT+ youth how best to cope with stigma-
related stress. The youth description and his or her stigma-related stress experiences 
will be developed using Phase 1 and Phase 2 input. The gender, race/ethnicity, and 
sexual orientation of the described LGBT+ emerging adult will match that of the 
participant.  
 
Control (C) Intervention: 
Participants randomly assigned to the control condition will be asked to write about 
what they have done since waking up that morning for 20 minutes across 3 Writing 
Days. This mundane control matches the time and activity of the EW and SA arms. 
 
The online program that captures participants’ writing will ensure that each participant writes 
for 20 minutes by not allowing the participant to advance until 20 minutes have passed. After 
each writing session, participants will be provided with the contact information of a local 
mental health resource center and a research assistant will review each submission within 24 
hours to ensure each participant’s safety. If participant expresses intentions of self-harm or 
harm towards others the research assistant will contact 911 in the Eastern Tennessee region. 
PI Pachankis, a licensed clinical psychologist, will also contact participants who indicate 
threat to self or others or severe emotional distress.  
 
Drs. Williams and Pachankis will train a graduate research assistants at ETSU to administer 
the consent process, tracking database, and online intervention systems. Phase 3 assessments 

Page 14 of 30 
 
and interventions will be delivered via Qualtrics.com, for which Yale University has an 
ongoing subscription. Research assistants will be trained to check the account once per day 
to ensure the safety of participants by reviewing their writing and to send reminder emails, 
text messages, and calls to participants who skipped a day. Drs. Williams and Pachankis will 
perform biweekly review of all systems to verify RA protocol adherence. 
 
 
 
 
4. Participant Population: Provide a detailed description of the types of participants who will be 
recruited into this study. 
 
Participants in this study will be Appalachian sexual minority (LGBTQ+) emerging adults 
who (i) are aged 18-29, (ii) self-identify as LGBTQ+, and (iii) currently live in Eastern 
Tennessee counties of Washington, Sullivan, Carter, Unicoi, Greene, or Hawkins County. 
(Note: there is no age-restriction for the pre-identified community leaders/stakeholders in 
Phase 1 and Phase 2.) 
 
Phase 1 and Phase 2 LGBTQ+ community leaders will meet the above criteria (with the 
exception of age) and are also affiliated with an online- or community-based organization 
that provides support services to Appalachian LGBTQ+ emerging adults. Community 
leaders were recruited to advise this study through in-person invitations to local LGBTQ+ 
advocates and health providers in Dr. William’s professional network (e.g., ETSU GSA, 
Northeast State GSA, PFLAG Tri-Cities, Tennessee Equality Project). LGBTQ+ community 
leaders have already indicated their support for this project and we have their letters of 
support on file for the NIH funding application. 
 
For Phase/Aim 3, participants must also have access to a minimum of 20 minutes per day of 
uninterrupted personal internet access. 
 
5. Describe how access to the population will be gained in the study. 
 
We will recruit participants for a focus group or individual interviews through postings and ads on geo-
targeted websites (e.g., Craigslist, Facebook, Reddit), bulletin boards and listservs at regional colleges 
and universities (e.g., gay-straight alliance [GSA] listserv); and in-person announcement and flyers at 
local community centers, bars, and the GSA of area schools. After completing the online screener, 
potential participants will be contacted by a trained research assistant (RA) who will explain the study 
purpose and procedures, verify eligibility, and assess consent. Age eligibility will be verified by photo 
ID, requiring each participant to email a snapshot of themselves holding their photo ID. In our 
experience, an LGB sexual orientation identity is difficult to fake, especially in interviews such as ours 
that assess LGB cultural knowledge and contexts specific to LGB individuals. 
 
6. 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. 

Page 15 of 30 
 
 
 Children 
 
 
 Healthy  
 
 Non-English Speaking 
 Prisoners 
 
 Economically disadvantaged  
 Decisionally Impaired 
 Employees  
 Pregnant women  
 Yale Students 
 
 
 Other vulnerable population (who?): 
 Psychology Pool 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential 
participants? 
 Yes  
 No (If yes, see HRPP Policy 310.4  for further requirements) 
 
 
7. Inclusion/Exclusion Criteria: What are the criteria used to determine participant inclusion or    
exclusion? 
 
Participants in this study will be Appalachian lesbian, gay, and bisexual (LGB) emerging 
adults who (i) are aged 18-29, (ii) self-identify as a sexual minority (LGBTQ+), and (iii) 
currently live in Eastern Tennessee counties of Washington, Sullivan, Carter, Unicoi, 
Greene, or Hawkins County. For Phase/Aim 3, participants must also (iv) and have access to 
a minimum of 20 minutes per day of personal internet access. (Note: there is no age-
restriction for the pre-identified community leaders/stakeholders in Phase 1 and Phase 2.) 
 
Phase 1 and Phase 2 LGB community leaders have already indicated their support for this 
project and we have their letters of support on file for the NIH funding application. 
 
SECTION V: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
 
1. 
Recruitment Procedures:  
a. Describe how potential participants will be identified and contacted, and by whom. 
 
We will recruit participants through postings and ads on geo-targeted websites (e.g., Craigslist, 
Facebook, Reddit), bulletin boards, and listservs at local colleges and universities (e.g., gay-straight 
alliance [GSA] listserv); mobile social networking apps (e.g., Grindr, Growlr, Instagram); and in-
person announcement and flyers at local community centers, bars, community events, and through the 
GSAs of local area schools. Also, Dr. Williams, at ETSU, maintains a “research repository” for people 
who sign up at community events to participate in future research studies. We will email the eligible 
LGBTQ+ individuals on this list with our study screener to determine their interest in participating in 
the present study. After completing the online screener, potential participants will be contacted by a 
trained research assistant (RA) who will explain the study purpose and procedures, verify eligibility, 
and review consent materials. Age eligibility will be verified by photo ID, requiring each participant to 
email a snapshot of themselves holding their photo ID. In our experience, an LGB sexual orientation 
identity is difficult to fake, especially in interviews such as ours that assess LGB cultural knowledge 
and contexts specific to LGB individuals.  
 
The Phase 1 and Phase 2 LGB community leaders have already indicated their support for this project 
and we have their letters of support on file for the NIH funding application. 

Page 16 of 30 
 
 
 
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.)  
 
Interested potential participants will complete an online screener through Qualtrics with consent 
assessed at the start of the screener. Those determined eligible by the online screener will receive a 
call from study staff, who will explain to the potential participant the study purpose and procedures, 
verify eligibility, and assess consent.  (See attached online screener text and consent form.) 
 
 
 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be 
used. 
 
 Flyers 
 
 
 
 
 Internet/Web Postings 
 
 
 Radio 
 Posters 
 
 
 
 
 Mass E-mail Solicitation  
 
 Telephone 
 Letter 
 
 
 
  
 Departmental/Center Website 
 
 Television 
 Newspaper 
 Through local NGO or other local contact  
 Social Media (Facebook, Twitter) 
Classroom recruitment  
Table set-up / in-person recruitment of public                   
Snowball sampling  
 
 
 
Other (describe): Also, Dr. Williams, at ETSU, maintains a “research repository” for people 
who sign up at community events to participate in future research studies. We will email the 
eligible LGBTQ+ individuals on this list with our study screener to determine their interest in 
participating in the present study. 
 
 
 
3. Targeted Enrollment: Give the number of participants: 
a.   Targeted for enrollment at Yale for this protocol_0/not applicable__ 
b.    If this is a multi-site study, give the total number of participants targeted across all 
sites_133 online (15 +10 +108)__  
 
 
4.  How was this estimate derived? 
 
15 LGB emerging adults (10 in Phase 1 and 5 in Phase 2) and 10 community leaders (10 in Phase 
1, five of whom will repeat in Phase 2) is the estimated number of participants needed to develop 
and refine the intervention materials before saturation is reached, as per our previous similar 
intervention development research (e.g., Pachankis et al., 2013; Pachankis, 2014).  
 

Page 17 of 30 
 
Phase 3 of the project, which aims to recruit 108 participants (36 per each of three conditions: 
EW, SA, C), is powered primarily to examine feasibility and acceptability. This phase will allow 
us to determine the preliminary efficacy of the interventions. Our sample size provides sufficient 
power (1- β = .8) to detect intervention effects consistent with effect size estimates identified in a 
meta-analysis of EW interventions across general population samples in which the average effect 
size (d) was .47 across physiological, psychological, self-reported health, and health behavioral 
outcomes. In order to detect an effect of .47 we need 36 participants per group. This sample size 
will also afford sufficient power (1- β = .8) to detect moderation effects found in previous 
examinations of EW moderation (e.g., social support) (i.e., d = .4610), and estimate the direct path 
to and from the proposed mediators (stress and self-regulation), as secondary aims. 
 
References 
 
  
 
Pachankis, J. E. (2014). Uncovering clinical principles and techniques to address 
minority stress, mental health, and related health risks among gay and bisexual men. 
Clinical Psychology: Science and Practice, 21, 313-330. 
  
 
 
Pachankis, J.E., Lelutiu-Weinberger, C, Golub, S. A., & Parsons, J.T. (2013). The 
development of an online risk-reduction intervention for young gay and bisexual men using 
social networking technology. AIDS and Behavior, 17, 2986-2998. 
 
5. Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent.  
 
John Pachankis, PhD 
Stephanie Chaudoir, PhD 
Stacey Williams, PhD  
Abbey Mann, PhD 
Sarah Job 
TJ Sullivan 
Roxanne Winston 
Charles Burton 
Erin McConocha 
Nicholas Fasanello 
Samantha Stone 
Emily Clark 
Cal Brisbin 
Ann Mondi 
Sarah Barr 
Michael Andre 
 
6. 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).  Describe the 
setting and conditions under which consent/assent will be obtained, including parental permission or 
surrogate permission and the steps taken to ensure participants’ independent decision-making.  
 

Page 18 of 30 
 
Informed consent will be obtained for all participants before completing the phone screener with a 
trained research assistant.  
 
For Phase 1, participants will receive a consent form. Study subjects who participate in the in-
person focus groups will be given and verbally read the respective consent form and for 
participation, will be required to sign the consent form. For Phase 1 participants opting for a 
telephone interview, a research assistant will read the consent form to the participant and a verbal 
consent will be required to participate.  
 
For Phase 2, participants will receive a consent form. Study subjects who participate in the in-
person interview will be given and verbally read the respective consent form and for participation, 
will be required to sign the consent form. Although Phase 2 participants are encouraged to 
interview in-person, research staff may opt to do the interview via phone for participants who are 
unable to attend in person, in which case a study staff member will read the consent form to the 
participant and a verbal consent will be required to participate.  
 
For Phase 3, interested participants will consent to share their information with study staff through 
the online screener to determine if they are eligible. Of those interested participants who have 
screened in as eligible, they will receive a call from a research staff member to confirm participant 
information, hear more about the study to attain verbal consent from the participant for Phase 3, 
which, if they agree to, will then lead to the online portal of the Phase 3 intervention. The consent 
form will require an electronic endorsement of consent before proceeding to the intervention. 
 
For Phase 3 follow-up participants, 15 participants selected at random will be e-mailed to schedule 
a follow-up interview. Participants will be asked to provide verbal consent over the phone to 
participate in the interview. 
 
 
7. 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 
 
After expressing interest in study participation through the online screener, potential participants will 
be contacted by a trained research assistant (RA) who will explain the study purpose and procedures, 
verify eligibility, and assess consent. Ability to provide consent will be assessed during the phone call 
with a trained research team member, and participants will complete in-person, verbal, or online 
consent (depending on the Phase of participant) before participating in their respective phase of the 
study.  
 
 
8. 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.  
 
We will collect consent before: (1) collecting potential participant information via online screener 
(2) during the study consent and enrollment phone call, (3) focus groups and structured interviews 

Page 19 of 30 
 
(Phase 1 and Phase 2), and (4) intervention participation and related outcome assessments (Phase 
3). For Phase 3 follow-up interviews, consent will be obtained verbally over the phone. 
  
See attached. 
 
9. 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). 
 
Only English-speaking participants will be enrolled in the study. 
 
10. 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.  
 
Although this study is unlikely to yield information subject to mandatory reporting, Tennessee law 
requires any person with knowledge of child abuse to report such information to the Tennessee 
Department of Children’s Services (by calling the Central Intake Child Abuse Hotline at 877-237-
0004). 
 
Tennessee law does not require mandatory reporting for self-harm or suicidality (T.C.A. § 33-3-
210); however, in the event that a participant is at imminent risk of harming themselves or another 
person, as determined by a study staff member with mental health training (Dr. Pachankis and Dr. 
Burton are licensed clinical psychologists), study staff will contact 911 to dispatch police or 
paramedics. Only the minimal necessary identifying information will be provided to these 
personnel.   
 
Participants will be notified of the reporting requirements under these circumstances during the 
consent process. 
 
11. Consent/Consent Waiver: 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.   
  I plan to obtain signed consent 
  I plan to obtain verbal or online consent       
  I plan to obtain signed consent for part of the study, and verbal or online consent for 
another part of the study. 
 
  I do not plan on obtaining consent due to the nature of the study (explain): 
    
We will collect documentation of consent for focus groups and interviews (on paper) and the 
intervention (electronically).  However, we will obtain verbal consent for the phone screen (built into 
the screening guide) and from any Phase 1 and 2 participants who select to participate by phone. 
 

Page 20 of 30 
 
 Requesting a waiver of documentation of consent (Note that an information sheet may be 
required.) 
 
  
If requesting a waiver of documentation of consent, please address the following: 
a. Would the signed consent form be the only record linking the participant and the 
research? 
 Yes  
 No  
b. Does a breach of confidentiality constitute the principal risk to participants?  
 Yes  
 No  
 
 
 
 
 
OR 
 
a. Does the research pose greater than minimal risk? 
 Yes If you answered yes, stop. A 
waiver cannot be granted.    
 No  
AND 
b. Does the research include any activities that would require signed consent in a non-
research context? 
 Yes  
 No 
 
  
 
 Requesting a full waiver of consent  
 
  
 
If requesting a full waiver of consent, please address the following: 
 
 
  
a. Does the research pose greater than minimal risk to participants?   
 Yes  If you answered yes, stop. A waiver cannot be granted.   
 No 
 
  
b. Will the waiver adversely affect participants’ rights and welfare? 
 Yes  
 No 
 
  
c. Why would the research be impracticable to conduct without the waiver?  
 
d. Where appropriate, how will pertinent information be returned to, or shared with 
participants at a later date?  
 
SECTION VI: PROTECTION OF RESEARCH PARTICIPANTS 
 
    Confidentiality & Security of Data: 
 
1. What participant information will you be collecting?  
 
briefly listed below, see Appendix for detailed information on each 
 
Demographics: During Phase 3 we will collect the following demographic information through our 
online screener, baseline survey, and hair cortisol collection survey: age, sexual orientation, gender 
identity, regional domicile, ethnicity, racial identity, relationship status, HIV risk behavior and 
status, height, weight, and socioeconomic status markers.  
 
Study Measures:  
 
Mental Health and Risk 

Page 21 of 30 
 
Center for Epidemiological Studies -- Depression Scale (CESD), Brief Symptom Inventory (BSI), 
Beck Anxiety Inventory (BAI), Suicidality, Suicidal Ideation Attributes Scale (SIDAS), Self-Injury, 
Alcohol Use Disorders Identification (AUDIT), Short Inventory of Problems-Modified for Drug Use 
(SIP-DU), Sexual Behavior with Main Partner (SB-MP), Sexual Behavior with Casual Partners (SB-
CP), Health Care Access and Experiences 
 
Moderators 
Ruminative Response Scale—Brooding Subscale (RRS), Multidimensional Scale of Perceived 
Social Support (MSPSS), Beck Hopelessness Scale (BHS), LGBTQ Identity Centrality, 
Developmental Milestones (Baseline Only) 
 
Mechanisms 
Cortisol Samples, Perceived Stress Scale (PSS), Barratt impulsiveness Scale (BIS), Columbia Card 
Task 
 
Sexual Minority Stress 
Gay-Related Rejection Sensitivity Scale (GRRS), Parental Attitudes Toward Child’s Sexual 
Orientation, Outness Inventory (OI), internalized Homophobia Scale (IHS), Everyday 
Discrimination—Sexual Orientation (EDSO), LGBT Victimization Experiences 
 
Religiosity  
Religious Affiliation, Religious Strain Scale (RSS) 
 
Qualitative Phone Interview Post-Session Questions 
 
2. Will any of the following identifiers be collected? 
 Names  
 All geographic subdivisions smaller than a State, including: street address, city, county, precinct, zip codes  
 Telephone numbers 
 Fax numbers  
 E-mail addresses 
 Social Security numbers  
 Medical record numbers 
 Health plan beneficiary numbers  
 Account numbers  
  All elements of dates (except year) for dates related to an individual, including: birth date, admission date, discharge 
date, date of death, all ages over 89 and all elements of dates (including year) indicative of such age, except that such 
ages and elements may be aggregated into a single category of age 90 or older  
 Certificate/license numbers  
 Vehicle identifiers and serial numbers, including license plate numbers  
 Device identifiers and serial numbers  
 Web Universal Resource Locators (URLs)  
 Internet Protocol (IP) address numbers  
 Biometric identifiers, including finger and voiceprints  
 Full face photographic images and any comparable images  
 Any other unique identifying numbers, characteristics, or codes  
 
Other potentially identifying information to be collected: 
 Audiotapes 
 Videotapes 

Page 22 of 30 
 
 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. If applicable, what methods and procedures will be used to safeguard the confidentiality and 
security of the identifiable study data and the storage media indicated above during and after the 
participant’s participation in the study? 
Do all portable devices contain encryption software? 
 Yes   
 No 
         If no, seehttp://its.yale.edu/secure-computing/protecting-yales-data/data-encryption and 
http://hipaa.yale.edu/guidance/policy.html 
  
The primary potential risk to participants is breach of confidentiality. Breaches of confidentiality 
will occur if a participant reports a clear intention to harm himself/herself or another person. 
Additionally, we are required by state law to report suspected cases of child abuse or neglect.  The 
likelihood that any additional breaches of confidentiality would occur is minimal, as steps will be 
taken to guard against this risk.  Study staff will be briefed on maintaining participants’ privacy and 
confidentiality and will be in possession of valid human subjects research training certificates. The 
emails verifying participant age with a photo of the participant and their ID will be stored on the 
secure study server. Once age has been verified and the image has been stored on our secure server 
the original email will be deleted from study staff emails and inbox trash will be emptied to protect 
participant confidentiality. Further, immediately upon providing consent, all participants will be 
assigned an identification number, which will only be kept on an electronic database that will be 
password protected and located on a designated study computer. This information will not be stored 
with any other data and no other identifying information will appear on any form. All contact with 
participants will be made by research staff under explicit guidelines to preserve confidentiality when 
telephoning, emailing, or mailing information to participants. All materials with identifying 
information will be kept in one password-protected electronic file.  Participants will provide research 
staff with contact information (email, phone numbers, and mailing address) for compensation and 
study retention purposes.  This information will be treated in the same confidential manner as all 
participant information, as described here.   
 
4. How will the research data be collected, recorded and stored?  
 
Research data will be collected via telephone, submitted electronically, and mailed via postal service 
(hair samples for cortisol testing).  
 
Screening data will be collected via telephone for Phase 1 and 2, whereby a study staff member asks 
the potential participant a series of eligibility questions and enters this information into an electronic 
database at our research offices. Phase 1 and Phase 2 data will be audio-recorded and stored 
electronically on secured encrypted hard drives; these data will be sent electronically to a 
professional transcription service. Phase 3 participants will complete the baseline surveys 
electronically at home, and will complete the writing assignments at home on their personal 
computer or tablet and will electronically submit the writing samples to our offices. Data from post-
study qualitative interviews will be audio-recorded, professionally transcribed, and stored 
electronically on secured encrypted hard drives. 
 

Page 23 of 30 
 
Hair specimens will be identified with participant ID number, not with participant name.  The 
diagnostic laboratory that will test cortisol levels will not have access to participant identifying 
information. All information collected from participants, including biomarker data, will be kept in a 
password protect file on our secure server. Hair samples will be discarded after cortisol level tests.  
 
All study computers will be encrypted and password protected. Online surveys (yale.qualtrics.com) 
will use an encrypted web service (https). 
 
5. How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard    
       Drive  
 Secured Server  
 Laptop Computer  
 Desktop Computer  
Audiotaping 
Videotaping 
Handwritten notes 
 Other 
 
6. If applicable, how will transfer of data to Yale be completed? See http://its.yale.edu/secure-
computing/protecting-yales-data/data-and-information-classification-yale-university 
 
Data will be transferred among study universities (Yale, ETSU, Holy Cross) using the HIPAA 
compliant Yale Secure Box.  
 
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. 
 
After study completion, data will be stored on an encrypted, password-protected server at the 
Yale School of Public Health. The identifiable data will remain separate from the remainder of 
participant data. Three years after study completion, the link to personal identifiers will be 
destroyed. After three years, the audio recordings from the phase 1 and phase 2 interviews and 
focus groups, as well as the phase 3 follow-up interviews, will also be destroyed. 
 
 
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) 
 
A Certificate of Confidentiality has been obtained. 
 
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. 
 
The study participants are at minimal risk for harm as a result of participation in the proposed 
research study. One risk of the proposed study is that some participants in the Phase 1 interviews 
and Phase 3 expressive writing condition will experience emotional discomfort as a result of 
talking or writing about their most stressful or traumatic LGB-related event. Although unlikely, it 
is possible that some participants may experience emotional discomfort in completing the 

Page 24 of 30 
 
quantitative assessments. Some participants might also experience physical discomfort from 
providing a section of their own hair. Breach of participants' confidentiality presents another 
possible risk.  The investigative team's strategies to protect against both risks are described below. 
 
 
Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
 
Protection Against Emotional Discomfort.  It is possible that participants may experience emotional 
discomfort in responding to self-report measures, talking about minority stressors, or completing the 
expressive or self-affirmation writing. While every possible step will be taken to minimize such risk, 
consent documentation will make it clear that if participants have any concerns about any aspect of 
the study they may refuse to continue with the study at any time, without penalty. In addition, we 
will remind participants during the course of their assessments that they can refuse to answer any 
questions and may discontinue participation at any time.  All research team members will be 
thoroughly trained in appropriate responses to participant distress by a licensed clinical psychologist. 
This training will address the appropriate handling of imminent threats and provision of referrals to 
free counseling services in less imminent clinical situations.  
 
Protection Against Breach of Confidentiality. The primary potential risk to participants is breach of 
confidentiality. Breaches of confidentiality will occur if a participant reports a clear intention to 
harm himself or another person. Additionally, health care professionals are required by state law to 
report suspected cases of abuse or neglect.  The likelihood that any additional breaches of 
confidentiality would occur is minimal, as steps will be taken to guard against this risk.  To protect 
participants’ confidentiality, we will obtain a Federal Certificate of Confidentiality prior to enrolling 
participants. All members of the research team have undergone rigorous training in maintaining 
participants’ privacy and confidentiality and are in possession of valid Collaborative Institutional 
Training Initiative (CITI) certificates. Further, immediately upon providing consent, all participants 
will be assigned an identification number which will only be kept on an electronic database that will 
be password protected and stored on a secure server. This information will not be stored with any 
other data and no other identifying information will appear on any form. All contact with participants 
will be made by research staff under explicit guidelines to preserve confidentiality when telephoning, 
emailing, or mailing information to participants. All materials with identifying information will be 
kept in one password protected electronic file.  Participants will provide alternative contact 
information (email, phone numbers, and mailing address) for compensation and study retention 
purposes. This information will be treated in the same confidential manner as all participant 
information, as described here.   
 
 
 
2. 
Data and Safety Monitoring Plan: All studies require the inclusion of a Data and Safety Monitoring Plan 
(DSMP) with  an explicit statement of overall risks (e.g., minimal, greater than minimal/moderate, or 
high), a means to address attribution and grading of adverse events and a description of procedures for 
monitoring the ongoing progress of the research and reporting adverse events. The Data and Safety 
Monitoring Plan should describe how the principal investigator intends to provide ongoing supervision 
and evaluation of the activities of the study including whether appropriate progress is being made. It 

Page 25 of 30 
 
should document the procedures and means to protect the welfare and safety of subjects and protect the 
integrity of the data.   
The plan must include provisions for data review and performance of safety reviews, at a specified 
frequency, as well as the plan for reporting to the HSC and/or other internal or external organizations.  
When participating in a multi-site study, the Yale principal investigator must indicate how safety reports 
and/or reporting of serious adverse events from other sites will be provided to the Yale HSC.   
 
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? Minimal 
b. 
If children are involved, what is your assessment of the overall risk level for the 
children participating in this study? n/a 
c. 
Copy, paste, and then tailor an appropriate Data and Safety Monitoring Plan  
from http://www.yale.edu/hrpp/forms-templates/biomedical.html  for 
i. Minimal risk 
ii. Greater than minimal/moderate risk 
iii.  
The principal investigator is responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews quarterly.  During the review process 
the principal investigator will evaluate whether the study should continue unchanged, 
require modification/amendment, or close to enrollment. 
 
The principal investigator and the Institutional Review Board (IRB) have the 
authority to stop or suspend the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems 
Involving Risks to Subjects or Others (UPIRSOs), including adverse events, are not 
anticipated. In the unlikely event that such events occur, Reportable Events (which 
are events that are serious or life-threatening and unanticipated (or anticipated but 
occurring with a greater frequency than expected) and possibly, probably, or 
definitely related) or Unanticipated Problems Involving Risks to Subjects or Others 
that may require a temporary or permanent interruption of study activities will be 
reported immediately (if possible), followed by a written report within 5 calendar 
days of the Principal Investigator becoming aware of the event to the IRB (using the 
appropriate forms from the website) and any appropriate funding and regulatory 
agencies. The investigator will apprise fellow investigators and study personnel of all 
UPIRSOs and adverse events that occur during the conduct of this research project 
(e.g., through regular study meetings, via email as they are reviewed by the principal 
investigator.)  The protocol’s research monitor(s), e.g., NIH, will be informed of 
serious or unanticipated adverse events within 5 days of the event becoming known 
to the principal investigator. 
 
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? 

Page 26 of 30 
 
ii. What provisions are in place for management of interim results? 
iii. What will the multi-site process be for protocol modifications? 
 
Drs. Chaudoir (co-PI at College of the Holy Cross) and Williams (Co-I at East Tennessee 
State University) will conduct biweekly conference calls to review study progress.  During 
these calls, any necessary protocol modifications will be discussed and submitted to all 
institutions’ IRBs for review.  Drs. Chaudoir and Williams will report any adverse event 
and unanticipated problem involving risks to subjects to Dr. Pachankis within 24 hours so 
that the IRB of each institution can be notified within 48 hours and so that NIH, if required, 
can be notified within five days. 
 
 
3. 
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.)  
 
Mental and physical health disparities among nonurban LGBTQ+ emerging adults is a clear public 
health concern. There is strong theoretical and empirical evidence to suggest that nonurban LGBTQ+ 
emerging adults in the expressive writing and self-affirmation conditions will experience salutary 
mental and physical health effects by participating in this research. Benefits to society in general are 
anticipated through the dissemination of research findings regarding the salutary effects of online 
writing interventions on mental and physical health for nonurban LGBTQ+ emerging adults. Results 
will better inform local and national public health agencies about potentially effective outreach that 
can be delivered to rural LGBTQ+ emerging adults. In sum, the potential benefits outweigh the 
potential risks to subjects, which are minimal. 
 
 
 
         SECTION VIII: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1.     Alternatives: What other alternatives, if any, are available to the study participants outside of the 
research? 
 
Study staff will be equipped with a list of resources to refer participants and potential participants 
to, including resources of medical, HIV/STD testing, psychological, substance use, and housing 
support services.  
 
2.  
Payments for Participation (Economic Considerations): Describe any 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; 4) that there 
are no restrictions to winning. 
 
 
 

Page 27 of 30 
 
 
Phase 1 focus group participants and Phase 2 interview participants will each receive $30 as a 
thank you for participating in the study.  
 
 
For Phase 3, participants will be paid $10 for each of 3 writing sessions and will be entered 
into a sweepstakes drawing for $100 if they complete all 3 writing sessions. Participants will 
receive graduated payment for completing the baseline ($20), post-intervention ($30), and 3-
month follow-up assessments ($40). They will receive $20 each for completing the first and 
second hair cortisol sample and will be entered into a second sweepstakes drawing for $100 if 
they complete all assessments. Assuming all participants complete all writing assignments and 
submit both hair samples, there will be a 1/108 odds of winning each $100 sweepstakes 
drawing. The use of graduated payment plans, sweepstakes drawings for intervention and 
assessment completion, and close communication with participants between follow-up 
assessments, have proven to be effective strategies to ensure 83-100% retention in our previous 
longitudinal research. Participants will receive compensation at four points: (1) upon 
completion of the baseline survey, (2) upon completion of writing samples and post-
intervention survey, (3) after the first hair cortisol sample, (4) and after the second hair cortisol 
sample. Participants will have the option to receive their payments either through Venmo or 
emailed Amazon gift card.  
 
Participants who choose to complete post-study qualitative interviews will be paid $30 for a 
60-minute phone interview. Participants will again have the option to receive their payments 
either through Venmo or emailed Amazon gift card. 
 
 
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.      
 
 
 
 
Participation in this study will generate no costs for participants, as it will be conducted entirely 
online.  
 

Page 28 of 30 
 
SECTION IX: 
 PRINCIPAL INVESTIGATOR AGREEMENT 
 
 
 
 
 
 
 
 
 
SECTION X 
 FACULTY ADVISOR AGREEMENT 
 
As the faculty advisor of this research project, I certify that: 
 The information provided in this application is complete and accurate. 
 This project has scientific value and merit and that the student or trainee investigator has the  
      necessary resources to complete the project and achieve the aims. 
 I will train the student investigator in matters of appropriate research compliance, protection of 
human subjects and proper conduct of research. 
 The research will be performed according to ethical principles and in compliance with all 
federal, state and local laws, as well as institutional regulations and policies regarding the 
protection of human subjects. 
 The student investigator will obtain approval for this research study and any subsequent 
revisions prior to initiating the study or revision and will obtain continuing approval prior 
to the expiration of any approval period. 
As the principal investigator of this research project, I certify that: 
 The information provided in this application is complete and accurate. 
 I assume full responsibility for the protection of human participants and the proper conduct of the 
      research. 
 Subject safety will be of paramount concern, and every effort will be made to protect participants’ 
      rights and welfare. 
 The research will be performed according to ethical principles and in compliance with all federal, 
      State and local laws, as well as institutional regulations and policies regarding the protection of   
      human participants. 
 All members of the research team will be kept apprised of research goals. 
 I will obtain approval for this research study and any subsequent revisions prior to my initiating the 
      study or any change and I will obtain continuing approval of this study prior to the expiration date      
      of any approval period or submit a request to close the study prior to its expiration.. 
 I will report to the HSC any unanticipated problems involving risk to 
      participants. 
 I am in compliance with the requirements set by the University and qualify to serve as the 
      principal investigator of this project or I have a faculty advisor. 
 I will identify a qualified successor should I cease my role as principal investigator and facilitate a 
smooth transfer of investigator responsibilities, if applicable 
 
_John Pachankis, PhD 
 
 
 
 
 
 
12/10/2015 
 
 
 PI Name (PRINT)  
 
 
 
 
 
 
Date 
_   
 
_____  
 
 
 
 
Signature 

Page 29 of 30 
 
 The student investigator will report to the HIC any serious injuries and/or other unanticipated  
      problems involving risk to participants.  
 I am in compliance with the requirements set forth by the University and qualify to serve as 
      the faculty advisor of this project.  
 I assume all of the roles and responsibilities of a Principal Investigator even though the student 
may be called a PI. 
 
 
 
 
___________  
______ 
 
 
 
_____ 
      Advisor Name (PRINT)  
 
 
 
 
 
Date 
 
_    
_____  
 
 
_______ 
 
Signature 
 
For School of Medicine Applications only: 
SECTION XI 
DEPARTMENT CHAIR’S ASSURANCE STATEMENT  
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a 
sponsoring company, patents, licensure) associated with this research project? 
 Yes (provide a description of that interest in a separate letter addressed to the HIC.) 
 No 
 
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and 
the sponsor of the research project, or its competitor or any interest in any intervention and/or method 
tested in the project that might compromise this research project? 
Yes (provide a description of that interest in a separate letter addressed to the HIC) 
No 
 
I assure the HIC that the principal investigator and all members of the research team are qualified by 
education, training, licensure and/or experience to assume participation in the conduct of this research 
trial. I also assure that the principal investigator has departmental support and sufficient resources to 
conduct this trial appropriately. 
 
   ____________________________  
 
 
 
 
 
 
   Chair Name (PRINT) and Signature   
     
 
 
 Date 
 
   _________________________________ 
   Department 
 
 SECTION XII 
YNHH HUMAN SUBJECTS PROTECTION ADMINISTRATOR ASSURANCE STATEMENT  
Required when the study is conducted solely at YNHH by YNHH health care providers. 
 
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that: 
 I have read a copy of the protocol and approve it being conducted at YNHH. 
 I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest. 

Page 30 of 30 
 
 The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital 
for this research project. 
 
  ______________________________________ 
 
 
 
 
 
 
 
 
    YNHH HSPA Name (PRINT) and Signature         
 
 
Date 
 
 
 
 
For HIC Use Only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date Approved  
 
 
 
Human Investigation Committee Signature 
 
This protocol is valid through ______________________________________________