A Randomized Controlled Trial Comparing Brief Peer Supported webSTAIR to Enhanced Wait List
Phase: NA
Conditions: Post Traumatic Stress Disorder, Depression, Emotion Regulation
Sponsor: Palo Alto Veterans Institute for Research

Marylene Cloitre, Ph.D. 
 
 
Protocol for RCT comparing Brief Peer Supported webSTAIR vs. Waitlist 
Study NCT04286165 
 
September 15, 2019 
 
Trial began January 20, 2020 and was completed September 28, 2022   
 
 

Marylene Cloitre, Ph.D. 
 
(1.) Principal Investigator  
Marylene Cloitre, Ph.D. 
 
 
(2.) Project Title and Abstract   
A Randomized Controlled Trial Comparing Brief Peer Supported webSTAIR to Waitlist  
This study will enroll 350 Veterans at a 2:1 ratio where 200 Veterans will be enrolled into a brief 
peer supported webSTAIR (BPS webSTAIR) and 100 will be supported into Waitlist. The 
purpose of the study is to assess the efficacy BPS webSTAIR in regard to four outcomes: 
reduction in PTSD and depression symptoms (measured by the PCL-5 and PHQ-8, 
respectively) and improvement in emotion regulation and work and social  adjustment 
(measured by the DERS-16 and WSAS, respectively). The active treatment is a 6-session 
modular treatment that focuses on learning emotion management skills where Veterans will 
have 10 weeks to complete the treatment. Assessments will occur three times for those in 
webSTAIR: baseline, post-treatment (10 weeks after randomization) and 8-week follow-up. and 
twice for those on waitlist (baseline and 10 weeks after randomization). It is hypothesized that 
BPS WebSTAIR will be superior to WL on all four outcomes. Mixed Effects Models will be used 
to evaluate the outcomes.   
 
 
(3.) Purpose.   
The purpose of this randomized controlled trial is to assess the efficacy of a brief version of 
webSTAIR (BPS webSTAIR) supported by peers compared to a waitlist condition (WL). Brief 
peer supported (BPS) webSTAIR is a 6-modulen web-based transdiagnostic program that 
provides skills training in emotion regulation; participants in this condition will be able to contact 
a Veteran peer trained in the program to obtain general support plus guidance about program 
use and application of skills.   
 
(4.) Scientific Rationale 
An 11-module version of webSTAIR with therapist coaching (Ortigo & Cloitre, 2018) has 
provided pilot data that the program is effective in reducing symptoms of posttraumatic stress 
disorder (PTSD) and depression as well as improving emotion regulation and work and social 
adjustment. Pilot data indicate that initial gains are made in the first 6 sessions. In addition, 
qualitative interviews with Veterans who have completed the program indicate high satisfaction 
with these modules. This study will assess whether a shorter version of the treatment (6 rather 
than 11 modules) and with peer rather than professional coaching will be effective compared to 
a waitlist condition. The BPS webSTAIR program was developed with the aim of providing a 
treatment for trauma-related symptoms that is effective, brief, engaging and likely to be 
completed by the user. The reduction of the number of modules creates a briefer treatment than 
our current web-based program. In addition, data indicated that integrating Veteran peers into 
mental health programs leads to better engagement and greater retention (Koenig et al., 2016), 
providing the rationale for including Veteran peers rather than therapists (e.g., psychologists, 
social workers). Given the absence of findings that a brief, peer-supported version of webSTAIR 
provides improvement in the above symptoms, we followed recommendations for the 
development and testing of psychotherapies and used a waitlist control as an initial test of 
efficacy.  
 
(5.) Focus 
 
(a) Specific research question(s). 

Marylene Cloitre, Ph.D. 
 
 
Aim 1: To establish the efficacy of BPS webSTAIR in improving symptoms of PTSD and 
depression, emotion regulation problems and work and social adjustment compared 
to a Waitlist Control.   
 
Hypothesis 1a: Compared to WL, BPS webSTAIR will provide greater improvement in 
PTSD symptoms as measured by the PCL5 (primary outcome) and depression as 
measured by the PHQ-8 (secondary outcome).  Assessments will be made at pre-
treatment, post-treatment, and 8-week follow-up for webSTAIR participants and pre and 
post-treatment (or 10 weeks from randomization) for WL.  
 
Hypothesis 1b: Compared to WL, BPS webSTAIR will provide greater improvement in 
emotion regulation as measured by the DERS-16 and overall functioning as measured 
by the work and social adjustment scale (WSAS) (secondary outcomes). Assessments 
will be made at pre-treatment, post-treatment and 8-week follow-up for webSTAIR 
participants and pre and post-treatment (or 10 weeks after randomization) for WL.  
 
 
(c) Product.   
It is proposed that the brief online therapy programs will be made available for free to 
Veterans through the Vets Prevail platform.  
 
(6.) Anticipated Impact.   
We anticipate that Veterans and other individuals with symptoms of PTSD and depression could 
potentially benefit in several ways by participating in this study. These benefits may include 
reduced symptoms of depression and PTSD and improved emotion regulation and work and 
social adjustment.  
 
(7.) Methods 
(a) Study design and approach  
This is a two-condition randomized controlled trial comparing BPS webSTAIR to WL. 
Participants will be enrolled in a 2:1 ratio (BPS webSTAIR vs. WL). Participants will be 
recruited from among users of the Vets Prevail website. A special effort will be made to 
enroll women Veterans via relevant ads on Facebook and other social media. Vets 
Prevail is responsible for enrolling 300 Veterans (200 into webSTAIR, 100 into WL). As 
noted in the study contract, enrollment is defined as the number of participants who 
have been accepted into the study and randomized into a treatment condition. Vets 
Prevail is responsible for recruiting and screening veterans and alerting NCPTSD RA to 
make phone contact with Veteran at all relevant assessment periods (baseline, post-tx 
and follow-up). The NCPTSD RA will facilitate completion of verbal informed consent, 
describe program including goal of completing program in 10 weeks answer questions 
about the study and motivate engagement in the program. The NCPTSD RA will then 
read through the baseline questions and document the answers. At the end of the call, 
the RA will recommend to the Veteran that they enter the Welcome Module and 
provide guidance to them at that time if they are ready to begin program.  
 
 
Individuals accepted into the study will either be provided  with access to BPS 
webSTAIR or placed on waitlist. Participants in BPS webSTAIR will complete a 
posttreatment assessment and 2-month follow-up.  Participants in the WL condition will 

Marylene Cloitre, Ph.D. 
 
complete a second assessment at 10th week, conclude their involvement in the study 
and be offered the Vets Prevail coping program including the use of webSTAIR.    
 
In the BPS webSTAIR condition, participants will first complete a welcome module to 
orient them to the program. After randomization, participants will have 10 weeks to 
complete the 6 modules. Every time the Veteran logs on they will have the opportunity 
to engage with a Veteran peer for support through the web program. Contacts can last 
for up to an hour. Veterans will receive a series of automated reminders and 
engagement emails that the Vets Prevail program sends at various points in the 
program.  
 
(b) Population and sample, including control group, if applicable.  
Participants will be 350 Veterans, where after attrition from baseline assessment we 
expect to enroll per condition (200 in BPS webSTAIR and 100 in Waitlist) across all 
gender identities who meet the following criteria:  
 
Inclusion Criteria 
1. Age 21 or older 
2. Able to read/write English 
3. Internet connection allowing stable access to VetsPrevail website 
4. Have experienced at least one traumatic event as indicated in the PC-PTSD-5 
5. A score greater than or equal to 3 on the PC-PTSD-5 OR greater than or equal to 2 on 
the PHQ2 on the screen.   
6. Enrollment into the webSTAIR study must be completed within two weeks of completing 
screener/eligibility based on symptoms.  
 
Exclusion Criteria 
1. Currently receiving a trauma-focused intervention (PE, CPT, EMDR, WET) assessed 
during baseline 
2. Being unlikely to benefit from therapy or Telemental health, for example: 
 
 -Cognitive difficulties as indicated during baseline assessment.   
 
 - Active psychosis as indicated during baseline assessment.    
 
 

Marylene Cloitre, Ph.D. 
 
 
(c)  Measures and Assessment Schedule    
 
 
Measure 
Items 
Purpose 
Time 
Screen 
        
Base 
Line 
Sessi
ons 
Pos
t-Tx 
2M 
FU 
Sociodems 
19 
Baseline Sample Characterization  
5min 
X 
 
 
 
 
LEC-5 
16 
Baseline Sample Characterization   
5min 
X 
 
 
 
 
PC-PTSD-5 
5 
PTSD Inclusion/Exclusion Criteria 
2min 
X 
 
 
 
 
PHQ-2 
2 
Depression Incl/Exclusion Criteria  
1min 
X 
 
 
 
 
PCL-5 
20 
Primary Outcome – PTSD  
7min 
 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
PHQ-8 
8 
Secondary Outcome – 
Depression 
5min 
 
X 
 
X 
X 
DERS-16 
16 
Secondary Outcome – Emotion 
Regulation  
10min 
 
X 
 
X 
X 
WSAS 
24 
Secondary Outcome -work and 
social functioning 
15min 
 
X 
 
X 
X 
DERS-6  
6 
Weekly Feedback  
2min 
 
 
X 
 
 
Web Metrics (example constructs/data) 
Construct 
Explanation 
Module Completion  
Per module; options of yes, no, partial 
Time on Each Module 
Time in minutes user spent in each module 
Total Time in Entire Program 
Time in minutes 
NEW: Brief 6-item DERS Score at 
the beginning of each module  
Sum of six items    
Frequency of Accessing Each Skill 
Frequency of each skill accessed/practiced outside of module 
Time Spent on Each Skill 
Time in minutes user spent in each skill 
Frequency of requesting chat 
Number of requests 
Duration of average chat 
Minutes 
Total Time Spent in Chat 
Minutes 
 
 
 
 
 

Marylene Cloitre, Ph.D. 
 
(d) Analysis Plan.   
Overview: The equivalence of the treatment conditions on baseline variables 
demographics and psychological variables) will be assessed and controlled (if 
necessary) in the final analyses. Other preliminary analyses will include examination of 
distributional properties of the measures. We will use transformations to improve 
distributions when necessary. Missing data patterns (from missed assessments and 
from dropout) will be examined and compared between conditions. Mixed Effects 
Models (MEMs) will be used to evaluate differences between the two treatments over 
time with time as a main effect and treatment-by-time as an interaction term. 
Participants will be random. 
(8.) Duration/Resources 
Proposed Duration of Study: The probable duration of the study will be approximately 24 
months. We expect that it will take approximately 3 months to build and test the webSTAIR 
program, obtain IRB approval and hire and train staff, 17 months to recruit the participants and 
approximately 5 additional months to finish collecting the data (last cohort of participants which 
will take a maximum of 18 weeks to complete), and approximately 3 months to clean, analyze 
data and prepare reports.  
 
 
Monthly Gantt Chart – Timeline for tasks and participant  
 
Tasks 
M01-03 
M04-06 
M07-09 
M10-12 
M13-15 
M16-19 
M20-23 
M24-26 
M27-29 
Build & Pilot test webSTAIR 
3Mo 
 
 
 
 
 
 
 
 
IRB Approval 
3Mo 
 
 
 
 
 
 
 
 
Hire and Train Staff 
3Mo 
 
 
 
 
 
 
 
 
Enroll Participants 
 
17Mo 
 
 
 
Final Follow-Up Data 
 
 
 
 
 
 
 
 
5Mo 
 
 
Data Analysis and Reports 
 
 
 
 
 
 
 
 
 
 
 
 
Funding: Internal NCPTSD funds will be used to cover the costs of participant reimbursement. 
Participants will be reimbursed $40 for the baseline assessment, $60 for the post assessment 
and $60 for the 2-month follow-up.  
 
 
 
(9.) References. 
Ortigo, K. M., & Cloitre, M. (2018, November). webSTAIR VA enterprise-wide initiative: A skills-
based web program with coaching support targeting MST for rural veterans. Presented 
in Symposium (Chair: A. Edwards Stewart), Technology for mental health in military and  
veteran populations, at Association of Behavioral & Cognitive Psychotherapy Annual 
Conference, Washington, D.C. 
Koenig, C. J., Abraham, T., Zamora, K. A., Hill, C., Kelly, P. A., Uddo, M., ... & Seal, K. H. 
(2016). Pre‐Implementation strategies to adapt and implement a Veteran Peer Coaching 
intervention to improve mental health treatment engagement among rural veterans. The 
Journal of Rural Health, 32(4), 418-428.