Evaluation of Web-Based CBT for Women Veterans With PTSD

The RCT will target women Veterans with PTSD to compare the adapted, web-based intervention
to phone monitoring only. Participants will include women Veterans with PTSD who are not
actively receiving PTSD treatment. They will be interviewed via phone for an initial phone
screening and eligibility interview and will complete additional online surveys at baseline,
post-treatment, and 12-, and 24-week follow-up.

Recruitment. Women Veterans who live in Pacific or Mountain Time Zones with an ICD code for
PTSD or a positive VA mandated PTSD screen, with no mental health stop-code in the last 2
months, and who are not on the high risk list for imminent danger to self or others, will be
identified using a VINCI data pull. Individuals with these criteria will be mailed up to two
invitation letters and a brochure describing the study inviting them to contact the study
office. If women do not contact the study office to opt out of the study, the investigators
may call them to follow-up. The investigators aim to obtain a sample of 100 individuals that
meet study inclusion/exclusion criteria after providing informed consent. Because the
investigators aim to recruit participants for approximately 24 months, the investigators will
aim to enroll and randomize 4-5 participants per month.

Procedure. The RCT will involve four assessment phases: initial phone screen to ascertain
interest and basic inclusion/exclusion eligibility, assessment of diagnostic eligibility in a
full eligibility interview, baseline survey of outcomes of interest prior to initiating
treatment, and three follow-up surveys of outcomes of interest at post-treatment and 12- and
24-weeks post-treatment. Patients will be randomized to condition following completion of the
baseline online survey. The eligibility interview and study coach phone calls will be
audio-recorded to ensure adherence to the study protocol.

Phone screen (10-15 minutes). When interested women Veterans contact the study office, study
personnel will provide an overview of the study and, for those still interested, conduct an
initial pre-consent screening. The purpose of the pre-consent eligibility screening is to
quickly determine which candidates are most likely to qualify, thus eliminating the need to
conduct consent and full eligibility interviews for those who are unlikely to meet study
criteria. If patients are found to be eligible following the pre-consent eligibility
screening, study staff will review the consent process, including willingness to be
audio-taped during assessments and study coach calls, answer any questions, and mail the
consent form to the participant to obtain written consent, along with a demographic form and
Life Events Checklist. The full eligibility interview will be scheduled at this time but will
only be conducted if and when the signed, written informed consent, HIPAA form, demographic
form, and Life Events Checklist have been received in the study office.

Eligibility interview (95-150 minutes). Study personnel will call the potential study
participant to conduct the eligibility interview over the phone after written, informed
consent has been received in the study office. The interview will assess current PTSD as
addressed by the CAPS interview as well as various exclusion criteria. During the course of
the interview, if study personnel are concerned about the fit of the study for the potential
participant, they will discuss with the PI. Potential participants who are of concern and may
show a high risk profile (e.g., multiple past suicide attempts, inpatient hospitalizations,
lifetime psychotic disorders) or prominent disorganization while on the phone will be
discussed by the PI and co-investigator Dr. Simpson for possible exclusion.

Respondents who do not meet eligibility criteria will be offered a resource list, referred
for treatment, and/or be further assessed for suicidality as appropriate. For those who are
eligible, contact information (e.g., address, telephone number) and contact information for
at least one friend or family member who typically would know the whereabouts of the
participant should study staff have difficulty making contact will be recorded. Eligible
patients will be invited to complete a baseline online survey.

Baseline and follow-up online surveys (60-90 minutes). The baseline and follow-up surveys (at
post-treatment and 12- and 24-week follow-ups) consist of an online survey. Each online
survey takes 60-90 minutes to complete. Participants will be compensated for the baseline
survey, for each of the follow-up surveys, and a bonus for completing all surveys. If the
interval between the eligibility interview and baseline survey is longer than four weeks, we
will require re-administration of CAPS via telephone to ensure PTSD status. Participants will
be given one-week and one-day reminders to complete the survey. Following completion of the
baseline survey, participants will be randomly assigned to one of the conditions.

Randomization scheme. Fifty participants will be randomized to the adapted, web-based
intervention and 50 to phone monitoring only. Participants will be randomized following their
completion of the baseline survey. Stratification of randomization by rural status will be
done to facilitate exploratory analyses of the impact of this variable on trial outcomes.
Following randomization, the study coach will arrange an initial telephone session with each
participant.

Study conditions. The treatment phase for both study conditions will last 8 weeks; however,
participants will have up to 12 weeks to complete the intervention and complete study coach
calls, if needed.

Phone monitoring condition. Participants randomized to the phone monitoring condition will
receive calls from a study coach once a week for 8 weeks for approximately 10-15 minutes. The
coach will assess their PTSD symptoms and safety.

DESTRESS-WV. Those randomly assigned to the web-based intervention will also receive calls
from a study coach once a week for 8 weeks to assess PTSD symptoms and safety; the coach will
also review the participant's progress with the DESTRESS-WV website. Participants will be
instructed to log-on to the website twice per week, with each session taking approximately
30-60 minutes. The web-based intervention consists of 16 sessions involving structured,
cognitive-behavioral components, including cognitive restructuring and in-vivo and imaginal
exposure. Participants will be reminded of the study office phone number as well as the
Veterans Crisis Line phone number at every logon.

Inclusion Criteria:

- age 18 or older

- female

- Veteran of the US military

- current PTSD

- reports routine access to computer and Internet

- willing to provide at least one collateral contact

- willing to allow investigators to leave phone messages pertaining to the study

- willing to be audio-taped during assessments and study coach calls

Exclusion Criteria:

- actively engaged in individual therapy in the past two months, or receiving couple's
or group therapy in the past two months that focuses on PTSD

- scheduled to receive a future individual therapy appointment or future couples' or
group therapy appointment focused on PTSD at a frequency of once per month or more

- active suicidal or violent ideation within the past two months or on the VA "high
risk" list for imminent danger to self or others

- moderate or extreme substance use disorder in the past year

- acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past
year

- unstable administration schedule or dosing of any antidepressant, anxiolytic, or
sedative-hypnotic