Clinical Effectiveness Trial of In-Home Cognitive Processing Therapy for Combat-Related PTSD

The study will use a 3-arm equipoise-stratified randomization design (Lavori et al., 2001;
Shalev et al., 2011) to evaluate the clinical effectiveness of CPT-C delivered in three
formats: Face-to-Face In-Office (F2F-O), Face-to-Face In -Home (F2F-H), and Telebehavioral
Health In -Home (TBH-H). The equipoise stratified design was specifically developed for
clinical effectiveness trials involving multiple treatments that may not be appropriate for
all research participants. The design will allow for complete randomization of those
participants who are interested and eligible for all three treatment arms. It will also allow
participants to opt out of one treatment arm if they are not interested or eligible for one
of the arms. Without this provision a large proportion of the potential participants would be
excluded from the study, seriously compromising external validity. Participants who elect to
opt out of one arm will be randomized to one of the two remaining treatment arms. For
example, the F2F-O treatment could be eliminated by those who are severely injured,
home-bound, or seriously concerned about stigma, and they then would be randomized to receive
one of the home-based CPT-C formats. The F2F-H treatment could be eliminated for participants
who are uncomfortable with the idea of a mental health provider coming into their home. The
telehealth arm could be opted out by veterans who are unable to use a computer, or cannot
situate it in a private area.

The equipoise design will be used because a significant confound exists with the use of a
completely randomized three-arm research design when all participants cannot be randomized to
all arms. With a completely randomized design, participants must be willing to be randomized
to all treatment arms or else they must be excluded. All participants willing to be
randomized to all arms will occupy a universal donor stratum. The universal donor
participants are randomized as in a completely randomized design, and they are able to
participate in all statistical analyses. Participants that elect to opt out of one arm will
enter a stratum comprising the remaining two arms, and they will be assigned at random to one
of the two remaining arms. These participants may participate (along with those in the
universal donor stratum) only in statistical analyses that compare arms to which they could
have been randomized. By making a choice, each participant assigns himself or herself to a
stratum, which consists of all the options that he or she finds equally acceptable. In this
design, those who are unable to attend clinic will be randomized to one of the in-home arms.
Those who are able to attend clinic will be given the option to reject any one of the three
treatments. The randomization plan defines four strata (i.e., those who accept randomization
to all three arms and those who reject one of the three treatments). Analyses will be done
pairwise using only participants who accepted randomization to two or three treatments, and
it will include stratum and the stratum-by-treatment interaction as design effects. Note that
this design is the only way to include an in-clinic arm and a sample of participants who are
unwilling or unable to be randomized to in-clinic treatment.

Specific Aims. The overall aim of the project is to conduct a 3-group randomized clinical
trial to evaluate the clinical effectiveness of CPT-C delivered in three formats: (1)
Face-to-Face In-Home CPT-C; (2) Face-to-Face In-Office CPT-C; and (3) Tele-Behavioral Health
In-Home CPT-C.

Objective 1: Conduct a randomized clinical trial to evaluate the effectiveness of CPT-C
delivered in three formats: (1) Face-to-Face In-Home CPT-C (F2F-H); (2) Face-to-Face
In-Office CPT-C (F2F-O); and (3) Tele-Behavioral Health In-Home CPT-C (TBH-H) employing
equipoise-stratified randomization.

Hypothesis 1: CPT-C delivered in F2F-H format will be more effective for the treatment of
PTSD (symptom reduction below diagnostic threshold on the CAPS-5) than F2F-O & TBH-H.

Hypothesis 2: CPT-C delivered in F2F-H format will result in greater improvement in secondary
outcomes (depression, alcohol consumption, marital and family functioning) than F2F-O &
TBH-H.

Objective 2: Determine if standard F2F-O CPT-C can be enhanced and delivered to special
populations (seriously injured, home-based rehab, rural living, severe avoidance) with
in-home therapies.

Hypothesis 3: In-home therapies (F2F-H and TBH-H) will result in lower perceived stigma of
seeking mental health care and higher treatment adherence (session attendance; out-of-session
assignment completion; dose of therapy) compared to mental health clinic-based therapy.

Hypothesis 4: Participants who opt to participate in the in-home therapies (i.e., decline
F2F-O) will have higher levels of treatment satisfaction than those in the F2F-O treatment
arm.

Inclusion Criteria

- Adult male and female active duty military and Veterans, with any previous military
deployment seeking treatment for PTSD

- Person has experienced a Criterion A event that is a specific combat-related event or
high magnitude operational experience that occurred during a military deployment. The
diagnosis of PTSD may be indexed to that event or to another Criterion A event.

- Diagnosis of PTSD determined by the Clinician-Administered PTSD Scale - Interview -
Version 5 (CAPS-5).

- Speak and read English.

- Participants taking psychotropic medications agree to work with their prescriber to
remain on stable doses of any prescribed psychotropic medications for the duration of
the intervention and through the first follow-up assessment as much as possible and as
medically indicated.

- Patient must reside within a 45-mile radius of the UTHSCSA STRONG STAR offices in San
Antonio.

- To participate in telemedicine study arm, participants must have access to a computer
with a high definition display, high speed internet access, and USB port for
installation of the HD telemedicine camera, OR be willing to use STRONG STAR equipment
with necessary specifications for the duration of the telemedicine treatment phase.

- The computer must be located in a private location where the participant will be
able to control access during treatment encounters (ensuring their privacy and
confidentiality).

- The computer must be accessible enough to the participant to allow for the
frequency and required number of encounters for the CPT intervention.

- The computer must have high speed internet access (e.g., cable modem, USB, T1/T2
connection).

- If a firewall is present on the participant's computer system, the participant
needs to be able to arrange for access control to the system to allow the
telepresence encounter to occur (i.e., they must either be able to open ports
through the firewall or know someone who can arrange this for them).

- The computer must be equipped with speakers or a standard headphone jack to allow
access to audio output from the encounter (i.e., to be able to hear the therapist
talking to them).

- Telemedicine will be mediated by the Cisco C20 Quickset Telepresence System, an
encrypted and could-based system. Because encounters are cloud-based, any
participant can use the system if they have a computer and web-browser capable of
processing most modern commercial internet services. Computer operating system
will not matter.

Exclusion Criteria

- Current suicide or homicide risk meriting crisis intervention that is a higher
priority than study participation.

- Endorsement of items pertaining to violence, arrest, probation, domestic abuse, or
other issues that might suggest study staff would be at risk entering the home to
deliver therapy as identified as part of the demographics.

- Alcohol and/or substance use that would prevent the participant from engaging in
therapy.

- Active psychosis.

- Moderate to severe brain damage (as determined by the inability to comprehend the
baseline screening questionnaires), as such individuals may be unable to fully benefit
from the cognitive intervention.