Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The study compares two intensive outpatient behavioral programs (Massed Prolonged Exposure
      versus Intensive Outpatient Prolonged Exposure) for the treatment of posttraumatic stress
      disorder (PTSD) in post-9/11 active duty service members and veterans. The researchers hope
      to learn if these programs improve treatment outcomes. The researchers predict that Intensive
      Outpatient Prolonged Exposure (IOP-PE) will be better at treating PTSD than Massed-Prolonged
      Exposure (Massed PE).
    

Detailed description: 
      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.
    

Intervention name(s): Massed Prolonged Exposure; Intensive Outpatient Prolonged Exposure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks. If necessary, the treatment window may be extended for another week.; The IOP-PE will include the same primary treatment components as the Massed-PE protocol (fifteen weekday 90-minute PE sessions delivered five days a week over a three-week period) plus eight augmentations designed to maximize treatment outcomes. Similar to the Mass-PE, participants will have three consecutive weeks to complete treatment; however, the treatment window may be extended another week if necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; PTSD; Post-Traumatic Stress; Trauma and Stressor Related Disorders; Trauma; Combat; Military; Veterans; Prolonged Exposure; Exposure Therapy; Behavior Therapy; Psychological Treatment; Psychotherapy