Evaluation of Web-Based CBT for Women Veterans With PTSD

The proposed research will occur in two phases. In the first phase, investigators will
conduct formative work. This will involve conducting semi-structured interviews with women
Veterans with PTSD to elicit their feedback on DESTRESS, make adaptations to the
intervention based on this data, and conduct a second set of interviews with the same
participants on instituted changes. Expert providers will also be interviewed throughout
this process. Phase I will also involve having 10 women Veterans go through the final
DESTRESS-WV intervention and phone support only (5 per group) to ensure overall quality
control.

In Phase II, investigators will conduct a 2-arm RCT. The RCT will target women Veterans with
PTSD to compare the adapted, web-based intervention to phone support only. Participants will
include women Veterans with PTSD in VISN20. They will be interviewed via phone for an
initial phone screening and eligibility assessment and provide additional assessments at
baseline, post-treatment, and 12-, and 24-week follow-up also via phone.

Recruitment. Women Veterans in VISN20 with an ICD-9 code for PTSD or a positive VA mandated
PTSD screen, and with no mental health stop-code in the last year, will be identified using
the Corporate Data Warehouse. Individuals with these criteria will be mailed an invitation
letter to participate in the study. Investigators will send 50% of the letters to the
Seattle/Portland area and the remaining 50% to the smaller and more rural areas to
oversample women living in geographically remote settings. Investigators anticipate
conducting initial phone screens with approximately 155 individuals in order to obtain a
final sample of 70 individuals that meet study inclusion/exclusion criteria after providing
informed consent and agree to randomization. The aim is to consent 100 individuals to ensure
that approximately 70 are eligible and participate in the protocol. In order to screen 155
individuals, investigators anticipate needing to send approximately 520 invitation letters
(estimated 30% response rate). They will aim to send 52 letters in 10 waves, every two
months, anticipating new enrollment of approximately 7 participants per wave.

Procedure. The RCT will involve four assessment phases: initial phone screen to ascertain
interest and basic inclusion/exclusion eligibility, assessment of diagnostic and safety
eligibility, baseline assessment of outcomes of interest prior to initiating treatment, and
three follow-up assessments of outcomes of interest at post-treatment and 12- and 24-weeks
post-treatment. Patients will be randomized to condition following the baseline assessment.
All assessments (eligibility, baseline, follow-up) and study therapist phone calls will be
audio-recorded to ensure adherence to the study protocol.

Phone screen (5-10 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, which consists of questions corresponding to inclusion
criteria/exclusion. 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 assessments for all potential participants. If patients are
found to be eligible following the pre-consent eligibility screening, the study coordinator
will review the consent, including willingness to be audio-taped during assessments and
study therapist calls, answer any questions, and mail the consent form to the participant to
obtain written consent. The full eligibility assessment interview will be scheduled at this
time and conducted only when signed, written informed consent has been received in the study
office.

Eligibility assessment (95-180 minutes). Study personnel will call the potential study
participant to conduct the eligibility assessment over the phone after written, informed
consent has been received in the study office. The interview will assess full eligibility
criteria. 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 schedule a baseline assessment.

Baseline and follow-up assessments (45-60 minutes). The baseline and follow-up assessments
(at post-treatment and 12- and 24-week follow-ups) consist of a telephone interview
conducted by a blind assessor. Following the baseline assessment, patients will be randomly
assigned to one of the treatment conditions.

Randomization scheme. Fifty participants will be randomized to the adapted, web-based
intervention and 50 to phone support only. Randomization tables will be created ahead of
time. Stratification of randomization by military sexual trauma and rural status will be
done to facilitate exploratory analyses of the impact of these variables on trial outcomes.
Following randomization, the study therapist will arrange an initial telephone session with
each participant.

Study conditions. The treatment phase for both study conditions will last 8 weeks. Those
randomly assigned to the web-based intervention will be instructed to log-on to the website
twice per week. All participants will receive weekly phone calls from the study therapist.
Participants will be carefully monitored for signs of clinical deterioration that may
jeopardize their health or warrant removal from the study. At each call, the study therapist
will assess PTSD symptoms. If there is an indication during any call of hopelessness or
despair, the study therapist will inquire about suicidal ideation using the Safety Protocol.
Any participant who becomes actively suicidal or homicidal and is unwilling to contract for
safety will be referred clinically, removed from the treatment protocol, and followed (for
intent-to-treat analyses of outcomes) with permission from the participant. Participants
will be fully debriefed at the final follow-up assessment or earlier if they leave the study
prematurely, as well as provided with a resource list.

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 therapist calls

Exclusion Criteria:

- actively engaged in specialty mental health care that involves psychotherapy or
behavioral case management in the previous two months

- 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