Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD

With an estimated 200,000 - 600,000 post-9/11 service members and veterans suffering from
combat-related posttraumatic stress disorder (PTSD; 7-20% of the 3 million who have
deployed), there is an urgent need for accessible therapies that are highly effective in
quickly treating PTSD to remission, enabling service members to stay fit for active duty and
veterans to integrate well into civilian life. While combat-related PTSD can be successfully
treated in post-9/11 active duty service members and veterans, recent studies indicate that
they do not derive the same degree of benefit from evidence-based behavioral treatments
(e.g., Prolonged Exposure; Cognitive Processing Therapy) as their civilian counterparts. This
suggests that combat-related PTSD is uniquely different from PTSD in civilians and that
treatments are needed that expand and augment established evidence-based treatments in order
to address the distinctive elements of combat-related traumas.

Prolonged Exposure (PE) is the PTSD treatment most extensively evaluated in clinical trials
with civilians and veterans, and there is strong scientific evidence to support its efficacy.
In standard outpatient PE, patients participate in weekly session over the course of two to
three months. However, given military work requirements, participation in standard outpatient
services is not always feasible. In the largest PE study with post-911 active duty service
members to date conducted by Foa and colleagues in 2018 found PE delivered in a massed format
(i.e., ten 90-minute PE sessions delivered on weekdays over 2 weeks) results in similar
treatment outcomes to those of PE delivered in the standard spaced format (i.e., ten
90-minute PE sessions delivered over 8 weeks).

The current study expands and augments the previous treatment protocol. More specifically,
this study examines whether intensive PE protocols can improve on treatment outcomes for
post-9/11 service members and veterans with combat-related PTSD. The purpose of this
randomized clinical trial is to compare the efficacy Massed-Prolonged Exposure (Massed-PE, 15
90-minute sessions delivered over three weeks) versus Intensive Outpatient Prolonged Exposure
protocol (IOP-PE, 15 days of treatment delivered over three weeks). In comparison with the
Massed PE examined by Foa, Massed-PE in this study has been modified to include 50% more
sessions and release from duty. IOP-PE has been further augmented and includes the following
modifications: (1) the use of a team-based treatment approach; (2) clinic-based completion of
daily homework assignments; (3) brief therapist feedback sessions after daily homework
assignments; (4) enhanced social support; (5) focusing on patients' three most distressing
traumas during imaginal exposure; (6) graduated imaginal exposure starting with the least
distressing trauma; (7) an optional telescopic, brief, timeline review of all traumatic
events that occurred during previous deployments; and (8) the completion of three
posttreatment booster sessions. Up to 400 post-9/11 active duty military and veterans will be
consented to obtain data from 230 for analysis. The main outcomes of the study include PTSD
diagnoses and symptom severity as measured by the Clinician Administered PTSD Scale for the
(CAPS-5) and the PTSD Checklist-for the Diagnostic and Statistical Manual for Mental
Disorders, 5th Edition(PCL-5). Participants will be assessed at baseline, while in-treatment
and at one-, three-, and six-months after treatment completion. The researchers predict that
IOP-PE will result in larger reductions than the Massed-PE in PTSD symptoms at the three
follow-up assessments.

Inclusion Criteria:

1. Active duty military service member or veteran (age 18- 65 years) who deployed in
support of combat operations post-9/11 seeking behavioral health treatment for PTSD.

2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
(CAPS-5).

3. Able to speak and read English (due to standardization of outcome measures)

Exclusion Criteria:

1. Current manic episode or a psychotic symptoms requiring immediate stabilization or
hospitalization (as determined by the bipolar and psychosis modules of the MINI).

2. Current and severe alcohol use warranting immediate intervention based on clinical
judgment.

3. Evidence of a moderate or severe traumatic brain injury (as determined by the
inability to comprehend the baseline screening questionnaires).

4. Current suicidal ideation severe enough to warrant immediate attention (as determined
by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical
risk assessment by a credentialed provider)

5. Other psychiatric disorders severe enough to warrant designation as the primary
disorder as determined by clinician judgment.