Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: Boston Medical Center

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Implementing a Skills Training Evidence-Based Treatment for  
Posttraumatic Stress Disorder (I-STEP) 
 
 
Protocol Version Number: H-41323, Version 1.9 
Protocol Version Date: 8 November 2023  
ClinicalTrials.gov number: NCT04937504 
Funding Mechanism:  K23MH117221 
Sponsor:  National Institute of Mental Health 
Grant title: An implementation science approach to optimizing evidence-based treatments for 
posttraumatic stress disorder (PTSD) for nonspecialty settings 
 
Principal Investigator: Sarah E. Valentine, PhD 
 
Phone: (617) 414-1989 
 
E-mail: Sarah.Valentine@bmc.org 
 
Statistical Analysis Plan- pages 19-20 
 

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TABLE OF CONTENTS 
1 List of Abbreviations ................................................................................................................. 3 
2 Protocol Summary .................................................................................................................... 3 
3 Background/Rationale & Purpose ............................................................................................ 4 
3.1 
Background Information ................................................................................................. 4 
3.2 
Rationale and Purpose .................................................................................................... 4 
4 Objectives.................................................................................................................................. 5 
4.1 
Study Objectives .............................................................................................................. 5 
4.2 
Study Outcome Measures ............................................................................................... 5 
4.2.1 
Primary Outcome Measures ............................................................................. 6 
4.2.2 
Secondary Outcome Measures ......................................................................... 6 
4.2.3 
Exploratory Outcome Measures ....................................................................... 6 
5 Study Design.............................................................................................................................. 6 
6 Potential Risks and Benefits ...................................................................................................... 7 
6.1 
Risks ................................................................................................................................. 7 
6.2 
Potential Benefits ............................................................................................................ 9 
6.3 
Analysis of Risks in Relation to Benefits .......................................................................... 9 
7 Study Subject Selection ............................................................................................................. 9 
7.1 
Subject Inclusion Criteria ................................................................................................. 9 
7.2 
Subject Exclusion Criteria .............................................................................................. 10 
8 Study Intervention .................................................................................................................. 10 
9 Recruitment and Retention Procedures ................................................................................. 11 
9.1.1 
Recruitment Procedures ................................................................................. 11 
9.1.2 
Retention Procedures ..................................................................................... 12 
10 Screening Procedures ............................................................................................................. 12 
11 Consent Procedures ................................................................................................................ 13 
12 Study Procedures .................................................................................................................... 13 
13 Assessment of Safety and Data Safety Monitoring Plan (DSMP) ........................................... 17 
13.1 Definitions for Safety Assessment................................................................................. 17 
13.2 Safety Review ................................................................................................................ 18 
13.3 Reporting Plans ............................................................................................................. 18 
13.4 Stopping Rules ............................................................................................................... 18 
14 Data Handling and Record Keeping ........................................................................................ 18 
14.1 Confidentiality ............................................................................................................... 18 
15 Statistical Plan ......................................................................................................................... 19 
15.1 Study Hypotheses .......................................................................................................... 19 
15.2 Sample Size Determination ........................................................................................... 19 
15.3 Statistical Methods ........................................................................................................ 19 
16 Ethics/Protection of Human Subjects ..................................................................................... 20 
17 Literature References ............................................................................................................. 20 

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1 
List of Abbreviations 
 
PTSD = Posttraumatic stress disorder; STAIR = Skills training in affective and interpersonal 
regulation; EBT = Evidence-based treatment; CPT = Cognitive processing therapy; PE = 
Prolonged exposure; VHA = Veterans health administration; I-STEP = Implementing a skills 
training evidence-based treatment for PTSD; IBH = Integrated behavioral health; RCT = 
Randomized control trial; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th 
edition; LEC-5 = Life events checklist for the DSM-5; PCL-5 = PTSD checklist for the DSM-5; RA = 
Research assistant; CAB = Community advisory board; PI = Principal investigator; CSQ-8 = Client 
satisfaction questionnaire, 8-item; ISEL-12 = Interpersonal support evaluation list, 12-item; BSI-
18 = Brief symptom inventory, 18-item; CFIR = Consolidated framework for implementation 
research; LIM = Level of integration measure; ICS = Implementation climate scale; EBPAS-15 = 
Evidence-based practice attitude scale, 15-item; ORCA = Organizational readiness to change 
assessment; PCIS = Perceived characteristics of intervention scale 
 
2 
Protocol Summary 
 
Title: 
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress 
Disorder (ISTEP) 
Population: 
Adult primary care patients with posttraumatic stress disorder 
symptoms, N=60  
Intervention: 
Behavioral health interventions, including web-administered and 
clinician administered brief Skills Training in Affective and 
Interpersonal Regulation (STAIR) for PTSD 
Objectives: 
Hybrid type 1 effectiveness-implementation trial to assess the 
feasibility, acceptability, and preliminary effectiveness of web- 
versus clinician-administered brief STAIR (primary outcome: PTSD 
symptoms, secondary outcome: functioning) while gathering 
information on implementation of both modalities. Findings will 
inform a full stepped-care approach to PTSD treatment that spans 
primary care and specialty care. 
Design/Methodology: 
60 patients were randomized, 30 in each condition (webSTAIR v. 
Brief STAIR). Participants completed study survey assessments at 
baseline (0 weeks), 15 weeks (active treatment), and 9-months 
post-randomization. To ensure consistency in timing of data 
collection, assessments are not linked to condition or amount of 
content completed.  
Subject Participation Duration: 9 months 
 
 
 
 
 
 
 

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3 
Background/Rationale & Purpose 
 
3.1 
Background Information 
 
Provide background information, study rationale, and purpose / study objective(s) and/or hypotheses 
for this study. PTSD is a significant public health challenge that disproportionately affects individuals 
receiving care safety net hospitals. The lifetime prevalence of exposure to interpersonal violence among 
patients seen in safety net primary care and behavioral health clinics may be as high as 94%, with 
current diagnosis of PTSD ranging from 33% to 46%. Despite high rates of trauma and PTSD in these 
settings, PTSD is vastly under-recognized and under-treated, with only 13% of individuals with PTSD 
receiving any form of mental health treatment. Of those who do access treatment, only 57% receive a 
minimally adequate dose of psychotherapy (defined as at least 4 hours of therapist contact).  
 
Racial, ethnic, and socioeconomic disparities in access to and retention in EBTs for PTSD can also be 
understood in terms of system- and client-level factors. At the system-level, low-income racial and 
ethnic minority individuals are more likely to live in neighborhoods with few mental health specialists. 
Further, providers in these settings have less access to specialized training in EBTs for PTSD, thereby 
rendering EBTs largely unavailable to clients. Clients in resource constricted communities are also more 
likely to access services through non-specialty primary care setting or community service agencies, and 
less likely to access specialty outpatient mental health services. These differences may reflect the 
pragmatic response to the low availability of mental health specialists and perceptions of lower quality 
of care, as well as consumer preferences for non-traditional mental health service settings. Preferences 
for informal support and non-specialty care may also be related to experiences of mental illness stigma 
and negative experiences with prior mental health treatment (including racial discrimination). The 
unavailability of EBTs for PTSD in usual care and underutilization of outpatient specialty care have led to 
concerning inequities in quality of care.  
 
Stepped care service delivery models are one approach to making PTSD treatment more accessible, 
equitable, efficient, and cost-effective. Stepped care approaches usually begin with interventions that 
are more convenient or acceptable to clients, and, if indicated, progress to more intensive care. By 
comparison, standard delivery systems often have one mode of treatment that demands intensive 
therapist time. Despite promise from a recently piloted stepped care approach to treating PTSD in 
children, stepped care models that include EBTs for PTSD at Step 1 have not been developed for adults. 
Existing first-line EBTs for PTSD, such as Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) 
require specialized and intensive therapist training and consist of 10 to 12 60- or 90-minute sessions. 
Despite strong support for the effectiveness of these treatments, access to training, supervision, and 
consultation is largely unavailable to community providers. Implementation trials suggest that the most 
consistent barrier to implementing EBTs is the lack of time to provide the intervention within their 
existing clinical system. Given these concerns, clinical researchers in the U.S. have advocated for the 
development of a stepped care approach that begins with brief, convenient, and patient-centered 
interventions for PTSD. 
11.0 
This study will be conducted in compliance with the protocol, applicable regulatory requirements, and 
policies and procedures of the Boston Medical Center and BU Medical Campus Human Research 
Protection Program. 
 
3.2 
Rationale and Purpose  

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Skills Training in Affective and Interpersonal Regulation (STAIR) is a safe, evidence-based intervention for 
PTSD that has been tested in specialty care and community-based settings, and has demonstrated 
effectiveness in improving PTSD symptoms. Both synchronous in-person /telehealth delivery and 
asynchronous web delivery (webSTAIR) have shown similar effect sizes in PTSD and depression symptom 
reduction (Bauer et al., in press; Jain et al., 2020). 
 
4 
Objectives 
 
4.1 
Study Objectives 
 
Our objective is to support the implementation of STAIR in BMC General Internal Medicine and Family 
Medicine as the new standard of care. The intervention will be delivered by usual care therapists in the 
integrated behavioral health practice. Participants who enroll in the study will be randomized to either 
in-person/telehealth STAIR or webSTAIR. Those who do not enroll in the study will still be able to receive 
STAIR in person or via telehealth as part of usual care. We hypothesize that offering a low intensity 
treatment for PTSD (i.e., STAIR) through primary care will improve access to and engagement in care for 
PTSD among BMC's patient population. 
 
This study will also allow us to compare the feasibility of two modes of treatment delivery (inperson/ 
telehealth v. webSTAIR), while gathering further evidence of the effectiveness of the intervention in our 
local setting. We hypothesize that both formats will be effective in reducing mental health symptoms, 
while webSTAIR may have some advantages in regard to uptake and long-term sustainability in usual 
care. 
 
4.2 
Study Outcome Measures 
 
Our evaluation will include a collection of both process measures to understand feasibility, acceptability, 
and satisfaction to help us make iterative improvements, and outcome measures to understand 
whether the treatment is improving patient PTSD symptoms, other mental health symptoms, and 
overall functioning as expected. Our evaluation will also rely on medical record data to evaluate 
healthcare utilization. All participants will be given a code that will be used on all data collection tools. 
The master key that connects participant codes to name, date of birth (DOB), contact information, MRN, 
and scheduled appointment date and time will be kept in a password protected word file saved on the 
password protected BMC Psychiatry network drive. The list will only be accessible to Dr. Valentine and 
study team staff. 
 
Participants' medical records will be accessed to obtain information about session scheduling, 
information about ongoing treatment at BMC, and other healthcare utilization data from 6 months pre-
enrollment to 9 months from baseline. Participants will be asked to sign a medical release form in the 
case that they move out of the area during the study or attend visits at a different hospital, so that we 
may obtain medical records from their new hospital/doctor. In addition, we will obtain the list of EPIC 
encounters of each enrolled patient in order to keep track of number of scheduled/attended/no-showed 
appointments. In total, the following information will be extracted from participant medical records: 
MRN, Name, DOB, problems lists, and encounter data (date and time of scheduled appointments, and 
date and time of unscheduled care [i.e., emergency department visits, urgent care visits, Boston 

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Emergency Services Team (BEST) safety evaluations, records of hospitalization]). Participants will be 
informed of this extraction during the informed consent process. 
 
4.2.1 Primary Outcome Measures 
 
Feasibility and Acceptability. We operationalized feasibility as participant retention and provider 
adherence to the protocol. Retention was calculated as the proportion of content for the assigned 
intervention that the participant completed (e.g., number of sessions [Brief STAIR] or number of 
modules [webSTAIR] completed / total number of sessions [5] or modules [10]). We utilized a 
researcher-developed fidelity checklist, adapted from the Brief STAIR fidelity checklist (Cloitre et al., 
2002) to assess adherence to the intervention. Adherence is reported as percentage of session 
components delivered per protocol. Overall study fidelity was calculated at study completion based on 
adherence scores from a random 20% of Brief STAIR sessions. Fidelity was assessed by two raters. We 
assessed client acceptability (satisfaction) using The Client Satisfaction Questionnaire (CSQ-8, Larsen et 
al., 1979), an eight item self-report measure. Each item is scored on a 4-point Likert scale from 1 “poor” 
to 4 “excellent” to indicate level of satisfaction with services. Higher scores indicate greater satisfaction 
with services.  
 
Preliminary Effectiveness, PTSD Symptoms. We use the PCL-542 to assess PTSD symptoms. The PCL-5 
includes 20 items, which map onto DSM-5 criteria for PTSD. Items are scored on a 5-point Likert scale to 
indicate symptom severity (0 – not at all to 4 – extremely), with a possible total score of 0-80. A score ≥ 
33 is considered clinically elevated.  
 
4.2.2 Secondary Outcome Measures 
 
Social and Emotional Functioning (Secondary outcome): We use the Interpersonal Support Evaluation 
List (ISEL-12)48 to assess social functioning and the Brief Symptom Inventory (BSI-18)49 to assess general 
mental health functioning.   
 
4.2.3 Exploratory Outcome Measures 
 
Changes in patterns of healthcare utilization is assessed via chart review from 6 months pre-treatment 
to 6 months post-treatment. We extract variables from the medical record including number of visits, 
visit types/departments, no-shows, etc. to characterize healthcare utilization. 
 
5 
Study Design 
 
I-STEP is a single site, unmasked, hybrid type 1 effectiveness-implementation36 trial which will assess the 
feasibility, acceptability, and preliminary effectiveness of Brief STAIR and webSTAIR while gathering data 
on implementation. We will randomize 60 patients (30 in each condition). Participants will complete 
study survey assessments at baseline (0 weeks), 15 weeks (active treatment), and 9-months post-
randomization (follow-up; see Figure 1). To ensure consistency in timing of data collection, assessments 
are not linked to condition or amount of content completed.  We hypothesize that: 1) Brief STAIR and 
webSTAIR will be effective in reducing PTSD symptoms (primary effectiveness aim) and mental health 
symptoms (secondary effectiveness aim); 2) Brief STAIR (clinician-administered) will have advantages 

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over webSTAIR (self-directed) in terms of treatment completion; and 3) webSTAIR will evidence 
advantages over Brief STAIR in regard to scalability and sustainability. Outcomes will be assessed using 
survey data and chart extraction. 
 
Self-report measures that have been shown to have excellent psychometric properties will be used to 
assess mental health and general well-being for each of the three study assessments (baseline, 15 week, 
and 9-month). This will include the LEC-5 and PCL-5 to assess trauma exposure (historical at the baseline 
study visit and any new traumatic events at the post-treatment and follow-up assessments) and current 
PTSD symptoms; the Difficulties in Emotion Regulation Scale (DERS) to assess emotion regulation; the 
Interpersonal Support Evaluation List (ISEL-12); the Posttraumatic Cognition Inventory (PTCI-9) to assess 
cognitions associated with PTSD; and the Brief Symptom Inventory (BSI-18) to assess for general mental 
health issues. Patients will also complete the Coronavirus Stressor Screener, the Everyday Discrimination 
Scale (EDS), and the Traumatic Symptoms of Discrimination Scale (TSDS) to understand stress response 
related to Covid-19 and racism. During the baseline assessment, patients will also be asked to complete 
a demographic questionnaire to collect data on gender, sexual orientation, age, education, marital 
status, ethnicity, and family income. During the baseline and 15-week assessments, participants will also 
be asked to complete the Consumer Experiences of Stigma Questionnaire (CESQ) to assess for perceived 
mental health stigma, the Attitude Toward Seeking Professional Help (ATPHS) to assess attitudes 
towards help-seeking, and the International Trauma Questionnaire (ITQ) to track their own symptoms. 
During the 15-week assessment only, participants will be asked to complete the Client Satisfaction 
Questionnaire (CSQ-8) to assess intervention acceptability. The 15-week assessment also includes an 
open text box where participants can provide suggestions and recommendations for how to improve 
STAIR. 
 
Patients may complete the questionnaires over REDCap, in which case the RA will email the participant a 
participant-specific link to the REDCap surveys using a secure BMC email address. This data will be 
collected on REDCap with no identifying patient information but the research staff at the clinic will hold 
the screen ID for eligible and interested patients to link the screening form to the patient. Participants 
will be given the option to complete the questionnaires inperson on paper-and-pencil (depending on 
COVID-related clinical and research guidance from the institution), or to have them administered 
verbally (in-person or by phone) by study staff. Regardless of the mode of data collection, study staff will 
be available to answer any questions that arise. All data will be entered into REDCap. 
 
6 
Potential Risks and Benefits 
 
6.1 
Risks 
 
Foreseeable risks or discomforts to subjects as a result of their participation in this study include: a) 
personal discomfort answering questions about trauma and other psychological symptoms, and b) 
confidentiality risks. 
 
Mitigation of Study Assessment Risks 
 
The risk of discomfort with answering questions about trauma and other psychological symptoms is 
expected to be short term. To minimize potential discomfort, surveys will be conducted in a private, 
comfortable setting (or in location of participant’s choosing if engaging in telehealth STAIR delivery or 

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webSTAIR). Participants will be assured that their participation is completely confidential and that 
neither their name nor any identifying information will be connected with their responses. If the 
participant feels upset or uncomfortable with any question, they will be free to refuse to answer the 
question without jeopardizing their study status or any regular clinical treatment received at BMC. They 
will be informed that they may end their study participation at any time for any reason without negative 
consequences.  
 
Additionally, all staff will be trained in how to manage distress related to answering questions regarding 
mental health symptoms, and the study PI is a BMC-credentialed and licensed Clinical Psychologist that 
can help study staff manage distressed participants. Participants who express severe distress will be 
referred for evaluation and treatment. If the participant expresses significant distress (but no suicidal or 
homicidal intent), the PI will make a collaborative plan with the participant in order to address their 
needs (e.g., brief support, referral, additional phone check ins).  
 
If the participant expresses suicidal or homicidal intent with a plan, standard protocol to assure safety 
will be followed (i.e., call the IBH clinical social worker on call, send patient to the emergency 
department, contact BEST). Information obtained from participants will indicate if they are at risk of self-
harm. Therefore, we have a suicide safety protocol in place to mitigate this risk. Using the Red Alert 
function on REDCap, study staff will be automatically notified when a participant indicates they are at 
risk for suicide (>0 on item 12 of the Brief Symptom Inventory-18 [BSI-19], administered at baseline, 15-
week, and 9-month assessments). Study staff will notify the principal investigator and the participants' 
clinician of the participant's elevated risk for suicide. The principal investigator will evaluate the 
participant's risk and connect them with appropriate resources and follow-up care (including scheduling 
a visit with their behavioral health providers in integrated care, referral to other BMC providers, or 
sending participants to the emergency department if necessary). The treatment follow-up plan will also 
be communicated to the participant's clinician. If for some reason the participant's safety cannot be 
assessed, the Boston Emergency Services hotline will be called to evaluate participant safety. In extreme 
situations, 911 may be called to ensure participant safety.  
 
In the case that suicidality is indicated during the participant's sessions with an IBH clinicians, the IBH 
clinician will follow the standard safety procedures used in IBH. This process involves clinician 
assessment of patient safety and negotiating appropriate follow-up care for the patient (including but 
not limited to: paging the Integrated Behavioral Health team, scheduling a followup visit, referral to 
outpatient psychiatry, calling the BEST hotline, sending patient to the emergency department). IBH 
clinicians will report any safety assessments and treatment followup plans related to patients 
participating in the study to the study team. The suicidality protocol (Psychiatric Emergencies) is the 
same for all conditions. Specifically, a person could disclose thoughts of harm to self or others in the 
context of a clinical appointment, through study measures, or during a study visit or check-in with study 
staff. Participants are not able to disclose this information during webSTAIR sessions because only the 
user has access to item-level information. We will inform participants in all conditions to reach out to 
their clinicians, the study team, call 911, and/or present to the ED if they are having a psychiatric 
emergency. 
 
Mitigation of Confidentiality Risk 
 
Breach of confidentiality is always a concern when participating in a research study. Additionally, the 
switch to remote data collection due to COVID-19 has created a research standard practice that is 

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inherently more vulnerable to confidentiality breaches than using paper and pencil. If hospital 
administration allows research to be conducted in person, we will offer this option to patients. However, 
we believe that the likelihood of a breach of confidentiality is low given the steps we have put into place 
to decrease this risk. Specifically, all participant information will be assigned a Study ID and this will be 
the only way to identify them in the data. Physical study documents with information about participants 
will be stored in a locked cabinet within a locked office at BMC. Electronic data (e.g., session audio-
recordings, webSTAIR data) will be stored on a secure, private, password-protected BMC network server 
that can only be accessed by members of the study team and will be labeled only with their Study ID.  
 
The webSTAIR site is protected by a data security assurance, ensuring that all content is password-
protected, item-level and written content is not viewable outside of an individual account, and all 
information on the site is maintained in a confidential and secure. Survey data will be stored on REDCap, 
a HIPAAcompliant, password-protected, access-restricted electronic database. One list of names and 
Study IDs will be kept on a private, password-protected computer separate from the coded data and 
accessible only to the study team. Documents with participant information on them (i.e., consent form) 
will be kept separate from their other data. Any data transmission will take place in pooled form and 
participants will be identified only by a Study ID. Though therapists will be able to use the STAIR 
program with all patients, the online program will only be offered to study participants. Training all site 
staff in using these programs and ensuring that the system runs smoothly for each participant would 
place a large burden on clinic staff. Furthermore, the program is encrypted to protect the privacy of 
patients and limit access to the program developers and key study staff. Since site staff cannot support 
the implementation of the online program without the involvement of study staff, the online program 
cannot be offered to all patients and will be limited to study participants. 
 
6.2 
Potential Benefits 
 
There is no direct benefit to participants from taking part in this study. However, patients experiencing 
symptoms of PTSD may benefit from the findings of the study. Specifically, this study is meant to 
understand if STAIR is helpful, feasible, and acceptable to patients seen in BMC primary care. 
 
6.3 
Analysis of Risks in Relation to Benefits 
 
This study advances our ability to assess if PTSD treatment offered in IBH is actually helping reduce 
mental health outcomes and healthcare utilization as expected and will provide important information 
from patients about what might need to change in order to be more effectively implemented in this 
clinic. We believe the risks to participate are reasonable given the importance of direct clinical 
knowledge that is expected to result from the study. 
 
7 
Study Subject Selection 
 
7.1 
Subject Inclusion Criteria 
 
To participate in research components, patients must endorse having experienced an event on the Life 
Events Checklist for the DSM-5 (LEC-5) and have elevated PTSD symptoms as measured by the PTSD 
Checklist for the DSM-5 (PCL-5), defined as reporting at least moderate severity of at least one question 

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1-5 and 6-7 and at least moderate severity on at least two questions 8-14 and 15-20. Additionally, 
participants must be over 18 years of age, able to engage in therapy in English. 
 
7.2 
Subject Exclusion Criteria 
 
Exclusion Criteria: Participants will be excluded from the study if they (a) do not have reasonable access 
to the technology needed for both conditions (e.g., phone, computer, internet access), (b) are 
experiencing bereavement (death of someone close) as primary clinical concern, and is, therefore, not a 
good fit for a PTSD-specific treatment; (c) are engaged in concurrent cognitive behavioral therapy for 
PTSD (PE, CPT, or EMDR), or (c) are not appropriate for care in IBH (e.g., need a higher level of care than 
IBH provides as determined by clinical judgement). 
 
8 
Study Intervention 
 
Clinician-administered Brief STAIR 
Participants randomized to Brief STAIR complete five 30-minute sessions with a study therapist 
via telemedicine or in-person based on patient preference and Covid-19 restrictions in the setting. Brief 
STAIR is five sessions and includes all core elements of traditional 10-session STAIR.33,34,44 Each session 
begins with review of the patients’ most recent PCL-5 score (documented in the medical record by the 
RA). Session 1 provides psychoeducation around the impact of trauma on emotions and relationships, 
an introduction to the treatment program structure, and a focused breathing exercise. Sessions 2-4 
focus on emotion regulation skills across the body, thought, and behavior channels (i.e., the cognitive 
behavioral therapy triad).45 These include emotion regulation techniques such as focused breathing and 
emotion surfing to down-regulate symptoms of over-activation (e.g.,, anxiety, hyperarousal) and 
techniques such as behavioral activation and pleasurable activities planning to up-regulate individuals 
when they are in a depressive or dysthymic state. Session 5 focuses on compassion, strategies for 
improving social engagement and sustaining relationships (e.g., conflict resolution), review of treatment 
progress, and a plan to continue use of skills.  
 
Web-administered STAIR (webSTAIR)  
Participants randomized to webSTAIR complete the program at their own pace. WebSTAIR 
includes the same content as Brief STAIR in ten online modules, which include audio, video, and text 
delivery of psychoeducation and therapy components, with interactive exercises to assist in skills 
practice.35 All webSTAIR participants will have a therapist on record for treatment oversight (in case 
higher-level of care is needed) and for treatment planning purposes. In some cases, webSTAIR 
participants will have access to their study therapists for sessions outside of this treatment, i.e., support 
that is not PTSD-specific. This may include regular therapy sessions (which typically occur every 4-6 
weeks in usual care), but not Brief STAIR or other trauma-focused therapies during the treatment 
window. The RA provides patients with unique login information, technology support, and lightly 
encourages engagement through biweekly reminder phone calls/texts. The principal investigator (PI) 
and RA have access to administrator-level login, which allows them to access behavioral data on 
participant progress (time spent, modules completed). To protect patient privacy, open text fields within 
webSTAIR (e.g., personal written answers to exercises and modules) are not viewable by study staff. 
Patients have access to the program for all 9 months of study participation, though progress is only 
reported back to study therapists during the active treatment phase (weeks 0-15).  
 
 Study Therapists: Training, Fidelity, and Supervision 

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Study therapists (N=10) are behavioral health specialists in integrated primary care, including 
Master’s-level social workers and doctorate-level psychologists. The PI, a nationally certified trainer in 
Brief STAIR, leads a 4-hour didactic training available to all therapists. Study therapists receive the Brief 
STAIR manual developed by Drs. Cloitre, Ortigo, & Gupta, and tailored to the local setting by the PI and 
CAB. Post-training, the study team sends a follow-up email to determine interest in research 
participation. Therapist participation in the study is voluntary. To account for therapist turnover and 
maximize uptake in usual care, trainings are ongoing as new hires and trainees join the clinic. During the 
trial, the PI provides ongoing supervision to study therapists through biweekly group consultation and 
individual written feedback on each session of the first two training cases. Consultation includes case 
review and discussion of real-time barriers/facilitators to implementation. All Brief STAIR sessions are 
audio-recorded to allow for fidelity assessment. Fidelity checklists (developed by Dr. Cloitre33 and 
adapted for our version of the manual) assess adherence, defined as completion of all session 
components (0 = not implemented, 1 = implemented, N/A = unable to complete), and competency, 
defined as how skillfully each component was delivered from 0 (not completed) to 7 (excellent). Average 
adherence and competency scores are calculated for each session. Fidelity monitoring for the purposes 
of training (written feedback on two training cases) will happen in real-time. Overall fidelity will be 
calculated at study completion based on 20% of Brief STAIR sessions selected at random. Fidelity will be 
assessed by two raters. 
 
9 
Recruitment and Retention Procedures 
 
9.1.1 Recruitment Procedures 
 
As a standard practice of care, IBH therapists determine who might benefit from PTSD treatment 
according to clinician appraisal for PTSD during their intake assessment. This a standard evaluation is 
already in place. If the patient screens positive on the PC-PTSD-5 or it is otherwise determined that PTSD 
treatment is appropriate, the therapist will ask permission to be contacted by study staff. The study RA 
will then contact the patient to provide information about STAIR and the research study, and to 
administer a study eligibility screener. Those who are not eligible or choose not to enroll in the study 
components will still receive standard of care from their IBH therapists. Study staff will go over the Brief 
Screening Agreement with the potential participant before administering the study eligibility screener. If 
the participant is ineligible or not interested in participating, the results of the study eligibility screener 
will be immediately destroyed.  
 
All recruitment will be clinician-mediated - meaning that IBH therapists will present patients with all 
treatment options for PTSD, including STAIR. If patient is interested in STAIR for PTSD, then the IBH 
therapist will briefly describe the study and ask the patient for permission for the study team to contact. 
The therapist will inform study staff that a patient is interested in participating. Once a patient has been 
introduced or referred to the study team, recruitment/screening will occur in a private exam room in 
the primary care clinic or our research center (dependent on institutional safety policies surrounding 
COVID-19), or over the phone. If study staff or patient is not immediately available, study staff will reach 
out to the patient over the phone to tell them more information about the study, complete screening (if 
not assessed by clinician), and, if eligible, schedule a time for the patient to complete informed consent 
with study staff prior to their next appointment in IBH. The Recruitment Script may be used for in-
person and over the phone recruitment, only in cases where the clinician has gained permission from 
patient for study staff to contact. If the patient qualifies for the study and completes informed consent, 
screening data will be retained. Due to the unacceptability and burden of conducting full screening 

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consent, conducting consent immediately after screening, or destroying screening data after assessing 
eligibility (justification detailed above), we are requesting a waiver of HIPAA authorization language so 
that we can retain screening data without full screening consent or immediate informed consent. If the 
patient does not qualify for the study or does not complete informed consent, screening results will not 
be retained by the research team, with the exception of overall count data. Written informed consent, 
completed in person or over REDCap via electronic signature, will be obtained prior to baseline 
assessment and treatment sessions, and includes notification that the study team will retain screening 
data if the participant agrees to participate and completes consent.  
 
For those determined eligible after screening, full written informed consent will be obtained as soon as 
possible (see justification to retain screening data without full screening consent or immediate informed 
consent). Study staff will complete the Informed Consent Form and subsequent assessments with 
interested patients. Study staff will inform the referring therapist of the patient’s decision on 
participation in the research components, so that the referring therapist can facilitate referral to PTSD 
treatment if necessary (either within IBH, in outpatient psychiatry, or in community-based clinics). 
Patients will be informed that they may receive treatment without participating in the research 
component, either within IBH clinic or via referral to outpatient psychiatry or community-based clinics. 
 
9.1.2 Retention Procedures 
 
Our team will make every attempt to support participant retention, including use of multiple methods 
for contacting participants (phone call, text message, messaging through the medical record, email, 
home address), send visit reminders, and provide incentives for visit attendance).  
 
10 Screening Procedures 
 
Screening will occur in two steps. If a patient screens positive for PTSD on the PC-PTSD-5 and/or is 
deemed a good fit for PTSD treatment by clinician judgment, the IBH therapist will refer the patient to 
the study team for study eligibility screening. Study staff will conduct screening in person in a private 
exam room (dependent on institutional safety policies surrounding COVID-19) or over the phone. Study 
staff will go over the Brief Screening Agreement with the potential participant before administering the 
screening questions. If the participant is ineligible or not interested in participating, the results will be 
immediately destroyed. If the Brief Screening Agreement is completed and the patient is still interested, 
study staff will set up a time to obtain written informed consent. The patient will complete the Informed 
Consent Form and subsequent assessments with study staff via REDCap prior to baseline assessment 
and treatment sessions. Patients may also be offered to complete these measures in person with study 
staff if hospital COVID-19 policies permit. Additionally, eligibility screening data assessed by researchers 
will be communicated to clinicians and may be added to chart by study staff or clinicians only for those 
who have provided informed consent to participate in the study (we have included necessary CoC 
language in the informed consent form). 
 
If the patient qualifies for the study and completes informed consent, screening data will be retained 
(we have provided justification to request a waiver of HIPAA Authorization language above; our 
Informed Consent Form and Brief Screening Agreement includes language notifying the participant that 
we will retain screening data if they are eligible and provide consent). If the patient does not qualify for 
the study or does not complete informed consent, screening results will not be retained by the research 
team, with the exception of overall count data. We will retain a running list of patient names that have 

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already been screened that will contain only their name, date of screen, and outcome (enrolled, 
ineligible, not interested), so that we can create a recruitment flow chart as well as not inadvertently 
approach the same patient twice regarding the study. Reasons for ineligibility will be kept in a separate 
list not linked to patient names. These lists will be kept in a secure private, password-protected drive 
that can only be accessed by members of the study team. After the study is completed and the 
recruitment flow chart is created, this list will be destroyed. 
 
11 Consent Procedures  
 
For patients who do not sign an informed consent form, no patient data will be retained. For patients 
who do sign the informed consent form and agree to participate, study eligibility screening data will be 
retained. Participants will be made aware prior to screening and during the consent process that data 
collected prior to informed consent will be retained and used as study data. 
 
When study staff complete screening, a Brief Screening Agreement is used before administering 
questionnaires. Language has been added to the Brief Screening Agreement to explicitly state that 
screening data will be retained if the participant is eligible and completes informed consent. Written 
informed consent, completed over REDCap via electronic signature (process explained in 17.1), will be 
obtained prior to baseline assessment and treatment sessions, and the informed consent form also 
includes notification that the study team will retain screening data if the participant qualifies and 
completes consent. 
 
For those determined eligible after screening, full written informed consent, completed over REDCap via 
electronic signature (or on pencil and paper), will be obtained by study staff either at the time of 
screening or at another scheduled time before participant completes study assessments or attends the 
first treatment session. The full written informed consent includes HIPAA authorization language to 
allow us to collect PHI and abstract the medical record, as well as a consent statement to allow for 
collection of evaluation data. The consent also notifies participants that if they agree to participate, we 
will retain their screening data. Patients will be informed that they may receive treatment without 
participating in the research component, either within IBH or via referral to outpatient psychiatry 
or community-based behavioral health clinics. Individuals obtaining consent will be study staff 
who are well trained in obtaining informed consent. Before the verbal consent, the RA will email the 
participant a participant-specific link to the consent form in REDCap using a secure BMC email address. 
The informed consent process will be administered by the RA. During the consent process, the RA will 
introduce the patient to the consent form and summarize its content. Participants will be given 
sufficient time to review the consent and ask any questions necessary in order to aid in their decision to 
participate. The participant will follow the link, read through the form (which has already been 
summarized by the RA) and will electronically sign it in REDCap. Paper copies of the informed consent 
will be used during in-person informed consent process. After reviewing paper copies with the RA, the 
participant will be provided a REDCap link to sign electronically before proceeding to surveys. 
Participants will be able to keep the printed copy and/or have an electronic copy of the consent form 
sent to them. 
 
12 Study Procedures 
 
The standard of care in Primary Care is to provide options for screening and treating 
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have several options for mental health treatment, including treatment with Integrated Behavioral 
Health (IBH) therapists, referral to behavioral health specialists in outpatient psychiatry, or 
referral to community-based behavioral health clinicians. This treatment is not research and 
takes place regardless of participation in the research components. Specifically, all embedded 
IBH therapists that work in Primary Care will have the opportunity to receive training and 
consultation in the STAIR intervention prior to start of the study and will be able to offer this 
treatment to any patient, regardless of a patient's decision to participate in research 
components, as a new standard of care. We will also train additional therapists in outpatient 
psychiatry at BMC in the intervention in case IBH therapists experience issues with capacity in 
their caseloads. However, the online, self-paced version of the therapy (webSTAIR) will only be 
provided to research participants for the time being. 
 
Clinic population: IBH provides mental/behavioral health treatment to patients in Primary Care 
who are experiencing a range of mental/behavioral health disorders and symptoms who would like the 
option of seeing a therapist for these issues through the Primary Care clinic. The Primary Care team 
includes Primary Care Providers, Nurses and Nurse Practitioners, Community Health Workers, and IBH 
therapists. IBH therapists include social workers, psychologists, and trainees receiving supervision. 
 
This project will evaluate the intervention for PTSD that is being used in IBH and use the data to 
iteratively improve the treatment and to explore how effectively the intervention is working in the 
primary care clinics. We will compare the relative advantages and disadvantages of the in -
person/telehealth and web-administered versions of STAIR to better understand and improve the 
quality of care in IBH. 
 
Eligibility: IBH patients with PTSD treatment needs (based on clinical screening or clinical judgment) may 
be appropriate for STAIR. The IBH clinician will ask patients for their permission to be contacted by the 
study team. The study RA will then contact the patient to provide information about STAIR and the 
research study, and to complete a study eligibility screener. Those who are not eligible or choose not to 
enroll in the study components will still receive standard of care from their IBH therapists, which may 
include in-person or telehealth STAIR. 
 
Inclusion Criteria: To participate in research components, patients must endorse having experienced an 
event on the Life Events Checklist for the DSM-5 (LEC-5) and have elevated PTSD symptoms as measured 
by the PTSD Checklist for the DSM-5 (PCL-5), defined as reporting at least moderate severity of at least 
one question 1-5 and 6-7 and at least moderate severity on at least two questions 8-14 and 15-20. 
Additionally, participants must be over 18 years of age, able to engage in therapy in English. 
 
Exclusion Criteria: Participants will be excluded from the study if they (a) do not have reasonable access 
to the technology needed for both conditions (e.g., phone, computer, internet access), (b) are 
experiencing bereavement (death of someone close) as primary clinical concern, and is therefore not a 
good fit for a PTSD-specific treatment; (c) are engaged in concurrent cognitive behavioral therapy for 
PTSD (PE, CPT, or EMDR), or (c) are not appropriate for care in IBH (e.g., need a higher level of care than 
IBH provides as determined by clinical judgement). With patient permission obtained from IBH therapist 
first, study staff will reach out to patients to go over the Brief Screening Agreement before 
administering the study eligibility screening questions assessing for other inclusion and exclusion 
criteria. If the participant is ineligible or not interested in participating, the results of the study eligibility 
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Adding HIPAA authorization language to our screening process would not be acceptable to our 
participant population, as evidenced by other researchers’ previous experience in conducting full 
screening consent with participants over the phone and conversations with our community determining 
patient eligibility, we would have to repeat the measure with other baseline assessments, causing undue 
patient burden. Therefore, we are requesting a waiver of authorization language in order to keep 
screening data of participants who are eligible for and interested in participating in the study and have 
set up a time to meet with research staff either in person or over telehealth to conduct the informed 
consent process. Language in the Brief Screening Agreement informs patients that we will retain their 
screening data if they enroll. Patients in the webSTAIR condition will provide email addresses to study 
staff. Study staff will then email a unique login username and temporary password to each participant 
for use on the webSTAIR website. See the webSTAIR Website: https://www.webstair.org/ 
 
Evaluation Data Collection: This is a QI project with an evaluation; data is used to iteratively improve the 
intervention and to explore whether and how the treatment is working. Our evaluation will include a 
collection of both process measures to understand feasibility, acceptability, and satisfaction to help us 
make iterative improvements, and outcome measures to understand whether the treatment is 
improving patient PTSD symptoms, other mental health symptoms, and overall functioning as expected. 
Our evaluation will also rely on medical record data to evaluate healthcare utilization. All participants 
will be given a code that will be used on all data collection tools. The master key that connects 
participant codes to name, date of birth (DOB), contact information, MRN, and scheduled appointment 
date and time will be kept in a password protected word file saved on the password protected BMC 
Psychiatry network drive. The list will only be accessible to Dr. Valentine and study team staff. 
 
Medical Chart Extraction Data: Participants' medical records will be accessed to obtain information 
about session scheduling, information about ongoing treatment at BMC, and other healthcare utilization 
data from 6 months pre-enrollment to 9 months from baseline. Participants will be asked to sign a 
medical release form in the case that they move out of the area during the study or attend visits at a 
different hospital, so that we may obtain medical records from their new hospital/doctor. In addition, 
we will obtain the list of EPIC encounters of each enrolled patient in order to keep track of number of 
scheduled/attended/no-showed appointments. In total, the following information will be extracted from 
participant medical records: MRN, Name, DOB, problems lists, and encounter data (date and time of 
scheduled appointments, and date and time of unscheduled care [i.e., emergency department visits, 
urgent care visits, Boston Emergency Services Team (BEST) safety evaluations, records of 
hospitalization]). Participants will be informed of this extraction during the informed consent process. 
 
Surveys for participants: Self-report measures that have been shown to have excellent psychometric 
properties will be used to assess mental health and general well-being for each of the three study 
assessments (baseline, 15 week, and 9-month). This will include the LEC-5 and PCL-5 to assess trauma 
exposure (historical at the baseline study visit and any new traumatic events at the post-treatment and 
follow-up assessments) and current PTSD symptoms; the Difficulties in Emotion Regulation Scale (DERS) 
to assess emotion regulation; the Interpersonal Support Evaluation List (ISEL-12); the Posttraumatic 
Cognition Inventory (PTCI-9) to assess cognitions associated with PTSD; and the Brief Symptom 
Inventory (BSI-18) to assess for general mental health issues. Patients will also complete the Coronavirus 
Stressor Screener, the Everyday Discrimination Scale (EDS), and the Traumatic Symptoms of 
Discrimination Scale (TSDS) to understand stress response related to Covid-19 and racism. During the 
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data on gender, sexual orientation, age, education, marital status, ethnicity, and family income. During 
the baseline and 15-week assessments, participants will also be asked to complete the Consumer 
Experiences of Stigma Questionnaire (CESQ) to assess for perceived symptoms. During the 15-week 
assessment only, participants will be asked to complete the Client Satisfaction Questionnaire (CSQ-8) to 
assess intervention acceptability. The 15-week assessment also includes an open text box where 
participants can provide suggestions and recommendations for how to improve STAIR. 
 
Patients may complete the questionnaires over REDCap, in which case the RA will email the participant a 
participant-specific link to the REDCap surveys using a secure BMC email address. This data will be 
collected on REDCap with no identifying patient information but the research staff at the clinic will hold 
the screen ID for eligible and interested patients to link the screening form to the patient. Participants 
will be given the option to complete the questionnaires inperson on paper-and-pencil (depending on 
COVID-related clinical and research guidance from the institution), or to have them administered 
verbally (in-person or by phone) by study staff. Regardless of the mode of data collection, study staff will 
be available to answer any questions that arise. All data will be entered into REDCap. 
 
Fidelity to the treatment: 
 
For in-person/telehealth STAIR, patients will be asked to consent to audio-recording of treatment 
sessions to ensure that fidelity and adherence to the intervention can be evaluated. Research staff will 
listen to 20% of audio-recorded STAIR sessions and complete a checklist of expected treatment 
components. Fidelity monitoring will happen in near real-time to assist with therapist training. For 
webSTAIR, study staff will monitor treatment progress via information collected by webSTAIR. This 
includes behavioral data on module completion, time in each module, total time in program, and the 
frequency and time spent access each therapy skill. IBH clinicians will also have access to the webSTAIR 
dashboard so they can monitor their patients’ progression through the treatment. The dashboard will be 
reviewed in consultation meetings. 
 
Randomization procedure: Participants will be randomized through a randomization software. Each 
patient will receive a unique study ID at the time of referral to the study that is not connected to 
identifiable data. Before randomization, the referred patient will complete the following enrollment 
procedures: (1) each referred patient will complete a clinical intake at with their IBH therapist, and (for 
those with PTSD treatment needs) give permission for study team to contact, (2) each referred patient 
will complete an assessment with study staff to determine eligibility for the study, (3) each referred 
patient will give study staff consent to participate in the study, and (4) each referred patient will 
complete the baseline assessments. Once a participant gives consent to enroll in the study, they will be 
provided with a unique ID number and this ID number will be connected to their identifiable data 
(access to identifiable data will be limited). Once all four steps of enrollment (clinical intake, eligibility 
assessment, consent, and baseline assessment) are completed, the participant will be randomized. 
Study design schedule: This evaluation is designed so that all patients who may benefit from PTSD 
treatment will be offered STAIR through in-person/telehealth format. Only those who enroll in the study 
are are randomized to webSTAIR will have access to the webSTAIR format. Group assignment will 
therefore be randomized for all eligible participants. We also acknowledge that, because clinic practices 
cannot change overnight, after STAIR is rolled-out, some patients still may not be provided STAIR, due to 
their treatment preference or their therapist's preference not to complete STAIR training. Therefore, 
even therapists who do not complete the STAIR training will be instructed to offer STAIR as an option 
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We will collect participant data for 9 months from baseline. Treatment plans will continue to be 
determined by usual care providers, the study has no involvement in any decisions regarding care. This 
means that a participant’s IBH therapist can continue the therapy, offer a different treatment option, or 
refer to other services at any time in the study and after the study is completed. At any time, patients 
can also choose to change their treatment plans, for example from webSTAIR to in-person/telehealth 
STAIR, or to another treatment option in the clinic. Access to webSTAIR will be discontinued at 9 
months. 
 
13 Assessment of Safety and Data Safety Monitoring Plan (DSMP) 
 
13.1 Definitions for Safety Assessment 
 
The following definitions will be used in the assessment of safety: 
 
Adverse Event (AE) is any untoward or unfavorable medical occurrence in a human subject, including any 
abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, 
temporally associated with the subject’s participation in the research, whether or not considered 
related to the subject’s participation in the research. 
 
Serious Adverse Event (SAE) is any adverse event that  
(1) results in death; 
(2) is life-threatening; 
(3) results in inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) results in a congenital anomaly/birth defect; or 
(6) 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 
(examples of such events include allergic bronchospasm requiring intensive treatment in the 
emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse).  
 
Life-threatening means that the event places the subject at immediate risk of death from the event as it 
occurred.  
 
Unanticipated Problem is defined as an event, experience or outcome that meets all three of the 
following criteria:  
• 
is unexpected; AND 
• 
is related or possibly related to participation in the research; AND 
• 
suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
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 
 
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• 
the known or foreseeable risk of adverse events associated with the procedures involved in the 
research that are described in (a) the protocol–related documents, such as the IRB-approved 
research protocol, any applicable investigator brochure, and the current IRB-approved informed 
consent document, and (b) other relevant sources of information, such as product labeling and 
package inserts; or 
• 
the expected natural progression of any underlying disease, disorder, or condition of the 
subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the 
adverse event. 
 
 
13.2 Safety Review 
 
This study is not greater than minimal risk. Unanticipated Problems, Adverse Events, and protocol deviations 
will be reported to the IRB as required by IRB policies. 
 
13.3 Reporting Plans 
 
  
The Principal Investigator at BMC/BU Medical Campus will report Unanticipated Problems, safety 
monitors’ reports, and Adverse Events to the BMC/BU Medical Center IRB in accordance with IRB 
policies: 
 
• 
Unanticipated Problems occurring at BMC/BU Medical Campus will be reported to the BMC/BU 
Medical Campus IRB within 7 days of the investigator learning of the event. 
• 
Adverse Events (including Serious Adverse Events) will be reported in summary at the time of 
continuing review, along with a statement that the pattern of adverse events, in total, does not 
suggest that the research places subjects or others at a greater risk of harm than was previously 
known. 
 
13.4 Stopping Rules 
 
The study has no pre-defined stopping rules.  
 
14 Data Handling and Record Keeping 
 
14.1 Confidentiality 
 
We will make every attempt to protect confidentiality. All participants will be assigned a study ID 
and questionnaires, and audio files will only have that study ID without other identifiable information. 
REDCap will be used to enter coded study data. Only coded data will be included in REDCap. Study staff 
may enter data from paper forms or from patient phone calls into REDCap or participants may complete 
surveys directly into REDCap. All paper data files will be kept in a locked file cabinet in a locked office. In 
person and telehealth intervention sessions will be audio-recorded. The recordings will be saved on a 
password protected BMC network drive that can only be accessed by members of the study team and 
labeled only with their Study ID. After the recording is saved on the password protected BMC network 
drive, the recording will be deleted from the audio-recording device. WebSTAIR (operated by the 
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password-protected, item-level and written content is not viewable outside of an individual account, 
and all information on the site is maintained in a confidential and secure manner. The VHA is not 
engaged in the same research project and will not have access to any study data collected by BMC (via 
RedCAP) for purposes of this study. They will not be able to link data gathered by webSTAIR to our data, 
as only BMC study team will know the link between webSTAIR usernames and Study ID numbers, and 
only the BMC study team will have access to data collected during study visits. webSTAIR is a password-
protected website. For this study, we have been allocated a set of 30 patient-level accounts (with 
unique usernames and passwords) to distribute to study participants. In addition, the program manager 
has created four administrator-level account (2 for BMC study staff, including PI and RA; and 2 for VA 
collaborators). The administrator-level account allows study staff to see patient engagement 
information such as the date, time, and duration of accessing various modules on the website and 
optional self-assessments so patients can track their progress. The website does not collect item-level 
information (e.g., fillable text boxes within the modules and worksheets), this information is only 
available to patients via their unique login. The webSTAIR website does not communicate with the EMR. 
Because we will contact patients over the course of the study and will access patients’ medical records, 
we will record their contact information, their date of birth, and their MRN. One list of names and 
contact information and Study IDs will be kept on a private password protected BMC network drive 
separate from any data collection tools and will only be accessible to the study team. All identifiable 
information will be transmitted, stored, analyzed, or otherwise exist only on HIPAA-compliant electronic 
systems that meet the standards for protection of PHI established by Boston Medical Center. As an extra 
layer of protection, we have a Certificate of Confidentiality because this project is NIH-funded. 
 
15 Statistical Plan 
 
15.1 Study Hypotheses 
 
Hypotheses:  
A. Brief STAIR will lead to significant change PTSD symptoms between baseline and 3 months.   
B. WebSTAIR will lead to significant change PTSD symptoms between baseline and 3 months.   
C. There will be no group differences in change in PTSD across conditions.  
 
15.2 Sample Size Determination 
 
Taking into account the quasi-experimental study design in the pilot of a comparison between pre- and 
post-implementation of the intervention, I based the power calculation on a recent but simple method 
proposed by Viechtbauer et al.109 suggesting a sample size of 60 as adequate. True probability is 
unknown, and therefore the lower bound of the probability will be considered in the context of the 
proposed study. Caution proposed by Kraemer is also considered, where clinical significance is the 
focus.110,111 
 
15.3 Statistical Methods 
 
Analyses were conducted in SPSS version 29. All continuous outcome variables were evaluated for and 
met the assumptions of normality (using both the Shapiro-Wilk test and the test statistics for skewness 
and kurtosis) and homogeneity of variance (using Levene’s test; Hahs-Vaughn & Lomax, 2020). Chi-
square tests and independent samples t-tests were used to examine differences in study variables 
between participants assigned to STAIR and webSTAIR conditions. Paired samples t-tests were used to 

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examine pre to post differences and pre to follow-up differences; effect sizes were calculated using 
cohen’s d. Participant retention, measured by percent of intervention content completed, did not meet 
the assumption for normality. To compare differences in engagement between STAIR and webSTAIR, we 
used the Kruskal-Wallis test, a non-parametric test that does not assume distributions between groups 
are similar.  Linear mixed models with repeated measurements nested within patients were used to 
examine changes in study outcomes across time points and between groups. We used the restricted 
maximum likelihood estimator and unstructured covariance matrices for residuals. We examined fixed 
effects of time, treatment group, and time by treatment group interactions for all study outcomes. In 
post hoc analyses, we used Spearman’s correlations to examine the correlation between engagement 
and baseline trauma symptoms of discrimination, stigma, and attitudes toward help seeking.  Post hoc 
LMMs examined primary outcomes only (PTSD symptoms, mental health symptoms, and depression 
symptoms) and included two indicators of engagement, percent of assigned intervention completed and 
additional contact hours (count of behavioral health encounters documented in the electronic medical 
records).   
 
16 Ethics/Protection of Human Subjects 
 
This study is to be conducted according to applicable US federal regulations and institutional policies 
(which are based in federal regulations, guidance, and ICH Good Clinical Practice guidelines). 
 
This protocol and any amendments will be submitted to the Boston Medical Center and Boston 
University Medical Campus for formal approval of the study conduct. The decision of the IRB concerning 
the conduct of the study will be made in writing to the investigator.  
 
All subjects for this study will be provided a consent form describing this study and providing sufficient 
information for subjects to make an informed decision about their participation in this study. The 
consent form will be submitted with the protocol for review and approval by the IRB. The consent of a 
subject, using the IRB-approved consent form, must be obtained before that subject is submitted to any 
study procedure. Consent will be documented as required by the IRB.   
 
17 Literature References 
 
 
Weathers F, Litz BT, Keane T, Palmieri PA, Marx BP, Schnurr PP. PTSD Checklist for the DSM-5. 2013; 
Available from: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp  
 
Cohen S, Mermelstein R, Kamarck T, Hoberman HM. Measuring the Functional Components of Social 
Support. In: Sarason IG, Sarason BR, eds. Social Support: Theory, Research and Applications. NATO ASI 
Series. Springer Netherlands; 1985:73-94. doi:10.1007/978-94-009-5115-0_5 
 
Derogatis LR, Fitzpatrick M. The SCL-90-R, the Brief Symptom Inventory (BSI), and the BSI-18. In: The Use 
of Psychological Testing for Treatment Planning and Outcomes Assessment: Instruments for Adults, 
Volume 3, 3rd Ed. Lawrence Erlbaum Associates Publishers; 2004:1-41. 
 
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation Hybrid Designs. Med 
Care. 2012;50(3):217-226. doi:10.1097/MLR.0b013e3182408812 
 

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Cloitre M, Koenen KC, Cohen LR, Han H. Skills training in affective and interpersonal regulation followed 
by exposure: a phase-based treatment for PTSD related to childhood abuse. J Consult Clin Psychol. 
2002;70(5):1067-1074. doi:10.1037//0022-006x.70.5.1067 
Jain S, Ortigo K, Gimeno J, Baldor DA, Weiss BJ, Cloitre M. A Randomized Controlled Trial of Brief Skills 
Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care. J Trauma Stress. 
2020;33(4):401-409. doi:10.1002/jts.22523 
 
Weiss BJ, Azevedo K, Webb K, Gimeno J, Cloitre M. Telemental Health Delivery of Skills Training in 
Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced 
Military Sexual Trauma. J Trauma Stress. 2018;31(4):620-625. doi:10.1002/jts.22305 
 
Cognitive Therapy of Depression. Guilford Press. Accessed February 15, 2023. 
https://www.guilford.com/books/Cognitive-Therapy-of-Depression/Beck-Rush-Shaw-
Emery/9780898629194 
 
Bauer A, Amspoker AB, Fletcher TL, et al. A Resource Building Virtual Care Programme: improving 
symptoms and social functioning among female and male rural veterans. Eur J Psychotraumatology. 
12(1):1860357. doi:10.1080/20008198.2020.1860357