Evaluation of Web-Based CBT for Women Veterans With PTSD
Phase: NA
Conditions: PTSD
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
Evaluation of Web-Based CBT for Women Veterans with PTSD 
 
NCT02917447 
 
April 6, 2020 
 
 

STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN 
Recruitment. Women Veterans with PTSD (target N = 100) were recruited for this RCT. 
Veterans who met the following criteria were identified by national VA electronic medical 
records: (1) age 18 or older, (2) female, (3) Veteran, (4) lives in a state with a Pacific or 
Mountain time zone (i.e., New Mexico, Arizona, Montana, Wyoming, Colorado, Utah, 
Washington, Idaho, Oregon, California, Nevada), (5) has an ICD code for PTSD or a positive 
VA mandated PTSD screen, (6) no mental health stop code (reflecting VA-based visits) in the 
last two months, and (7) not on the high risk list of imminent danger to self or others. 
Approximately 30,000 women met these criteria. Because the study aimed to enroll women who 
were not actively engaged in current mental health care (defined as prior two months), this 
criterion was applied when identifying potential participants via medical records. Randomly 
selected women were mailed letters approximately every other week in batches of 100-200 
letters inviting them to potentially participate in the study. The invitation letter included an 
overview of the study and directed women to contact the study office for more information. Each 
individual may have received up to two invitation letters and up to three follow-up phone calls to 
assess her interest and eligibility. 
Inclusion criteria for the RCT included: (1) age 18 or older, (2) female, (3) Veteran, (4) 
current PTSD as assessed by the CAPS-5 interview, (5) reports routine access to computer and 
Internet, and (6) provides written research informed consent using IRB-approved form, including 
willingness to be audio-taped during the eligibility interview and study coach calls, willingness 
to be left voice messages, and availability of at least one collateral contact.  
Exclusion criteria included: (1) on VA “high risk” list for imminent danger to self or 
others, (2) currently at imminent danger of harm to self, according to the M.I.N.I. International 

Neuropsychiatric Interview – Suicidality instrument, (3) actively engaged in individual therapy 
in the past two months, and/or receiving couple's or group therapy in the past two months if that 
therapy focuses on PTSD at a frequency of once per month or more, (4) scheduled to receive a 
future individual therapy appointment, or a future couples’ or group therapy appointment if that 
therapy focuses on PTSD, at a frequency of once per month or more, (5) moderate or severe 
alcohol use disorder or any non-alcohol substance use disorder in the past year excluding mild 
cannabis or any nicotine abuse, (6) acute psychosis, psychotic episode, or psychotic disorder 
diagnosis within the past year, (7) homicidality, and (8) unstable administration schedule or 
dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related 
medication changes in the four weeks prior to the eligibility interview). Furthermore, women 
who participated in earlier phases of the research (qualitative interviews and the pilot study) were 
not included. These criteria are consistent with PTSD RCTs and PTSD telehealth research 
(Morland et al., 2009; Schnurr et al., 2003). 
Study procedure. The study involved three assessment phases: eligibility, baseline, and 
follow-up (post-treatment and 3- and 6-month follow-ups). The eligibility interview was 
conducted by a study assessor via telephone. Baseline and follow-up assessments were 
conducted online. Participants were randomized to condition following the baseline assessment. 
Eligibility screener and interview. When interested women Veterans contacted the study 
office, study staff conducted a pre-consent eligibility screening, which consisted of questions 
corresponding to inclusion/exclusion criteria. The purpose of the pre-consent eligibility 
screening was to quickly determine which candidates are most likely to qualify, thus eliminating 
the need to conduct consent and full eligibility interviews for all potential participants. If patients 
were found to be eligible following the pre-consent eligibility screening, study staff reviewed the 

consent, answered any questions, and mailed the consent form to the participant to obtain written 
consent. The full eligibility interview was scheduled at this time and conducted only when 
written, signed consent had been received in the study office. The full eligibility interview 
included a collection of demographic information as well as the Mini International 
Neuropsychiatric Interview (MINI) to assess substance use disorders (Lecubrier et al., 1997) and 
the CAPS-5 (Weathers et al., 2013). PTSD diagnosis on the gold-standard CAPS was required 
for study eligibility. The staff member who conducted the eligibility interview in the role of 
study assessor did not serve as the participant’s study coach to avoid potential bias during the 
assessment. If the interval between the eligibility interview and baseline assessments was longer 
than four weeks, we required re-administration of CAPS via telephone to ensure PTSD status. 
Baseline and follow-up assessments. The baseline and follow-up assessments (at post-
treatment and 3- and 6-month follow-ups) consisted of an online survey hosted by 
SurveyMonkey (SurveyMonkey Inc., Palo Alto, CA). Information collected during the online 
baseline assessment served as a baseline from which to evaluate the efficacy of the study 
intervention on the primary outcome (PTSD symptom severity) and secondary outcomes 
(depression and quality of life). Information about concurrent treatment that might moderate the 
efficacy of the study intervention (“co-therapies”) was also gathered at the baseline assessment 
(e.g., mental health specialty visits, PTSD-related pharmacotherapy use, and chaplain or similar 
community support resources) and throughout the course of the study. Following the baseline 
assessment, patients were randomly assigned to one of the study conditions. Participants received 
$25 for the baseline assessment, $30 for each of the three follow-up assessments, and a $35 
bonus for completing all assessments (for a total maximum of $150). 

Randomization. We used the Sealed EnvelopeTM program (Sealed Envelope Ltd., 2016) 
to generate a randomization table to condition (1:1 allocation ratio) using a permuted block 
design with block sizes of two and four to maximize the likelihood of a balanced sample size 
across arms  (Schulz & Grimes, 2002), and stratifying by rural status  to facilitate exploratory 
analyses of the impact of this variable on trial outcomes and to maximize the likelihood of 
balance across arms on this potential characteristic (Kernan et al., 1999). We defined rural status 
as living more than 40 miles away from the closest VA medical facility, in line with eligibility 
criteria used by the Veterans Access, Choice, and Accountability Act and shown to be a marker 
indicating decreased likelihood of receiving psychotherapy (Pfeiffer et al., 2010). 
DESTRESS-WV intervention. For the DESTRESS-WV condition, the initial telephone 
session with the study coach served to 1) provide brief psychoeducation regarding PTSD; 2) 
complete a safety plan that is individualized to the patient for times when she is distressed; 3) 
introduce the intervention model, the study coach role, and the participant’s role; 4) introduce the 
patient to the website’s structure; and 5) problem-solve any obstacles to using the website. 
Participants were asked to log on the website twice a week each week for eight weeks and 
complete different homework activities. Nonetheless, up to 12 weeks of access was provided. 
The coach called the participants once a week at an agreed upon time while they were 
completing the program to monitor symptoms and safety, review progress through the website, 
provide encouragement, review a particular skill or strategy when applicable, review barriers to 
treatment compliance, and address barriers to treatment (target call time is 15 minutes). The 
coach had access to a back-end of the DESTRESS-WV website where she monitored 
participants’ progress, and this was monitored weekly between every study coach call.  

Before completing each session, participants were encouraged to plan 30-60 minutes free 
from interruption, during which they can review that session’s content. Sessions covered basic 
coping skills (deep breathing, progressive muscle relaxation, and reaching out for support); 
cognitive strategies to identify and challenge unhelpful thoughts; in-vivo exposures; writing 
about stressful, daily life events; and writing about and processing a traumatic experience. 
Sessions could only be accessed at a minimum of 24 hours apart to promote appropriate pacing 
and provide opportunity to complete homework assignments. 
DESTRESS-WV homework. After the first session, each time participants logged on to 
the DESTRESS-WV site, they were prompted to enter responses from the previous session’s 
homework assignment. Broken up into units, these assignments promoted stress-reduction skills, 
self-monitoring, application of stress management techniques to each in vivo exercise, 
processing and coping with a particularly salient or intense traumatic memory as well as 
significant current-day stressors, and relapse prevention. Participants were required to complete a 
given homework assignment before proceeding to the next session, otherwise the sessions did 
not progress. Participants were also reminded of the study coach’s phone number and could call 
the coach at any time with questions or concerns. Study coach voicemails were monitored daily 
during regular business hours. 
Phone monitoring only. The purpose of the phone monitoring condition was to assess 
participants’ safety and symptoms, similar to the DESTRESS-WV condition, while providing 
general support in a safe atmosphere where participants were actively being listened to and 
empathized with by the coach. The aim of using this approach was to provide an alternative and 
to control for nonspecific therapeutic factors, including regular supportive contact with study 
staff. 

The initial telephone session served to: (1) provide brief psychoeducation regarding 
PTSD; (2) complete a safety plan that is individualized to the participant for times when she is 
distressed; and (3) introduce the study coach and the participant’s roles. Participants were 
expected to attend calls weekly and, in addition to answering questions regarding their weekly 
symptoms, were encouraged to discuss any issues from the week they would like. The coach 
used active listening and reflective statements but did not actively encourage the use of CBT 
strategies, as in the DESTRESS-WV condition. Calls were expected to last an average of 15 
minutes, similar to the length of calls in the DESTRESS-WV condition. 
Outcome measures. Baseline, post-treatment, and 3- and 6-month surveys all assessed 
outcome measures and were conducted online, thus eliminating the need for a blind assessor. 
Primary outcome. The PTSD Symptom-Checklist –Version 5 (PCL-5) was used to assess 
symptoms of PTSD at baseline and follow-up assessments (Weathers et al., 2013). This is a 20-
item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms 
in the last month. It can be summed for a total severity score, ranging from 0-80. PCL-5 test 
scores have demonstrated good internal consistency (α = .96), test–retest reliability (r = .84), and 
convergent and discriminant validity with samples of Veterans (Bovin et al., 2015). 
Secondary outcomes. The Patient Health Questionnaire (PHQ) is a brief self-report 
assessment of common mental disorders and was used to assess symptoms of depression (PHQ-
8; Kroenke et al., 2009). The eight items specifically correspond to symptom-based diagnostic 
criteria in DSM-IV, and demonstrate good validity, reliability, and sensitivity to change 
(Kroenke & Spitzer, 2002). The Quality of Life Enjoyment and Satisfaction Questionnaire – 
Short Form (Q-LES-Q-SF) was used to assess quality of life (Endicott et al., 1993). It consists of 

16 items and has been shown to have good internal consistency, test-retest reliability, validity, 
and sensitivity in clinical settings (Stevanovic, 2011).  
Process outcomes. Feasibility of DESTRESS-WV was examined by completion of 
intervention sessions and retention of participants through the duration of the intervention. For 
the DESTRESS-WV treatment arm, we defined a “treatment completer” as someone who 
completed at least nine of the 16 intervention sessions, and for the phone monitoring only arm 
we defined a treatment completer as someone who completes at least five of the nine coaching 
calls. We hypothesized that no more than 30% of the women in this study will dropout from the 
study (withdraw or be lost-to-follow-up), similar to overall dropout rates for PTSD trials (Imel et 
al., 2013). Of the women who do not dropout, we hypothesized that at least 70% will be 
treatment completers as per the above definitions, similar to participation rates found by Engel et 
al. (2015). 
Acceptability was evaluated by participants in both study groups using the Client 
Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979), an 8-item measure on a 4-point Likert 
scale that assesses general satisfaction with treatment. For example, participants rate the quality 
of the service they received, the extent to which the program met their needs, the extent to which 
they were satisfied with the amount of help received, and whether services helped them deal 
more effectively with their problems. The measure has good internal consistency, construct 
validity, and criterion-related validity (Attkisson & Zwick, 1982). An additional item assessed 
how satisfied participants were with receiving treatment through the phone or Internet (based on 
assigned condition), from 0 (not at all) to 4 (very much). Finally, seven items created for the 
study assessed satisfaction with the study coach, ranging from 0 (not at all) to 4 (very much). 
Items included how much the participant liked the coach, how helpful the coach was, and how 

much the participant felt the coach listened and understood them. We hypothesized that overall 
mean satisfaction will be greater than the mid-point of the scale.  
Participant safeguards. As noted above, during the first phone call with the study coach, 
participants in both conditions created a personalized safety plan. This included identifying 
healthy coping strategies that could be done alone (e.g., going for a walk, engaging in a 
pleasurable activity) as well as identifying individuals in their support network they can call. The 
safety plan also included the Veterans Crisis Line number and the study coach’s contact 
information.  
Participants were carefully monitored for signs of clinical deterioration that may 
jeopardize their health or warrant removal from the study. During the treatment phase, at each 
call (nine calls for a total of eight weeks), the study coach assessed PTSD symptoms using an 
abbreviated PTSD Checklist (PCL) that consisted of seven items (three re-experiencing 
symptoms, two avoidance symptoms, two hyperarousal symptoms). Participants rated each 
symptom from 1 (not at all) to 5 (extremely). If there were an increase of seven or more points 
on this abbreviated PCL (i.e., 20% of the maximum possible score) from the baseline score (i.e., 
score on first coach call before initiation of treatment), the study coach discussed with the 
participant whether it appears that the exacerbation was related to study participation or was 
likely situational (e.g., life stressors or changes in circumstances often precipitate PTSD 
exacerbations, as do trauma anniversaries). If it appeared to be the former, the possibility of 
withdrawing from the treatment aspects of the study were discussed with the participant and PI 
and a decision reached mutually.  
Any patient who became actively suicidal was assessed by the study coach using the 
study’s Safety Protocol. The Safety Protocol assessed and identified whether current risk was 

minimal (hopelessness or ideation only), moderate (ideation and plan but no intent), or imminent 
(ideation, plan and intent). Clear guidelines were offered in accordance with each risk level (e.g., 
moderate risk entailed providing the participant with the Veterans Crisis line and local resources 
and recommending follow-up mental health care in 24 hours).  
All participants who withdrew from the treatment protocol were given the option of 
continuing to provide information at the follow-up assessments for intent-to-treat analyses of 
outcomes. Additionally, participants randomized to DESTRESS-WV were reminded of the study 
office phone number and the Veterans Crisis Line during each logon. Participants were also 
reminded of these phone numbers and other resources after each follow-up assessment. 
Power. This is a pilot RCT designed to provide estimates of feasibility of the treatment 
approach, dropout rates, acceptability, and initial effect sizes. The study’s budget and timeline 
allows us to plan to randomize 100 participants. For the primary outcome, Litz et al. (2007) 
observed a differential effect size of 0.41 at 8 weeks (n = 33), 0.10 at 3 months (n = 24), and 0.95 
at 6 months (n = 18) when comparing change from baseline in PTSD symptoms for participants 
randomized to DESTRESS (n = 24) versus supportive counseling (n = 21), with an overall 
dropout rate of 27% prior to the end of 8 weeks of therapy. In a second trial of DESTRESS by 
Engel et al. (2015) where participants were randomized to optimized usual care (n = 37) or 
DESTRESS (n = 43), the 6-week effect size was 0.23 (n = 64), the 12-week effect size was 0.47 
(n = 62), and the 18-week effect size was 0.08 (n = 66), with an overall dropout rate of 18%. 
As noted above, we hypothesized no more than 30% of participants will dropout prior to 
the end of the study. Thus, with the goal of randomizing 100 participants and assuming a sample 
size of at least n = 35 participants per group, we have 80% power to detect an effect size of 0.68 
using a two-sided Type I error rate of 5%.  

Following the recommendation of Bacchetti (2010), Table 1 presents a sensitivity 
analysis of possible results from this study in terms of 95% confidence intervals for the 
difference in change from baseline in PCL-5 for the DESTRESS-WV versus the phone 
monitoring only group. Engel et al. (2015) state that for their study of DESTRESS versus 
optimized usual care (OUC), for PCL-4 the observed 12-week change from baseline (Mean ± 
SD) was 12.6 ± 16.6 for the DESTRESS group and 5.7 ± 12.5 for the OUC group. In our table 
the pooled standard deviation of change from baseline varies from 8 to 22, while the possible 
difference in change from baseline between groups varies from 0 to 14. The numbers in 
parentheses after the confidence intervals are the effect sizes. 
Table 1. Sensitivity Analysis of Possible Results for Difference in Change from Baseline 
Between Groups (95% Confidence Intervals and Effect Sizes) 
 
 
Difference = 14 
Difference = 7 
Difference = 0 
SD = 8 
[10.2, 17.8]  (1.8) 
[ 3.2, 10.8]  (0.9) 
[  -3.8,   3.8]  (0) 
SD = 15 
[  6.8, 21.2]  (0.9) 
[-0.2, 14.2]  (0.5) 
[  -7.2,   7.2]  (0) 
SD = 22 
[  3.5, 24.5]  (0.6) 
[-3.5, 17.5]  (0.3) 
[-10.5, 10.5]  (0) 
 
RCT data analytic strategy. We used summary statistics (e.g., means, standard 
deviations, percentages) and graphs (e.g., strip charts, box plots, bar charts, scatter plots) to 
compare participant demographics at baseline by assigned treatment group (DESTRESS-WV vs. 
phone monitoring only), and to initially compare outcomes by treatment group. Analyses 
followed the intent-to-treat principle, so that all participants who had at least a baseline 
assessment and were randomized were included in the analyses. For descriptive purposes, 
analyses were conducted to determine group comparability on baseline participant characteristics 
and potential moderator variables. Because differential attrition can compromise inference about 
treatment effectiveness, we compared study dropouts versus non-dropouts and treatment non-
completers versus treatment completers on demographic and outcome variables. Dropouts 

included those who withdrew from the study or were lost-to-follow-up; treatment non-
completers may or may not be study dropouts as treatment non-completers were invited to 
continue participating in study assessments. Treatment completers include those completing nine 
or more sessions of DESTRESS-WV or, for those in the phone monitoring condition, five of the 
nine coaching calls. 
To account for repeated measures within subjects, we used a linear mixed effects model 
for the analysis of the primary outcome, PCL-5, with the subject treated as a random effect.  We 
have PCL-5 measures at four times during the course of the study: at baseline, 8 weeks (the first 
post-treatment assessment), and 3 and 6 months post-treatment.  The response (dependent) 
variable was PCL-5 score, and the predictor (explanatory) variables included treatment group, 
assessment visit (treated as categorical), and a treatment group by assessment visit interaction 
term, along with the covariates trauma category and rural status.  A significant treatment group 
by visit interaction term indicates a significant difference in change from baseline between 
treatment groups. Results include adjusted means, standard errors, and 95% confidence intervals 
for each group at each time, confidence intervals for change from baseline at each time within 
each group, confidence intervals for differences in change from baseline between the two groups 
at each time, p-values, and effect sizes.  We also used linear mixed effects models for the two 
secondary outcomes, depression and quality of life.   
Linear mixed effects models easily accommodate missing values. We compared the rate 
and timing of dropouts between treatment groups, and also baseline demographics and outcome 
scores between treatment completers and non-completers. If necessary, we will perform 
sensitivity analyses by using only participants who were treatment completers and using multiple 
imputation to deal with missing values.