Clinical trial NCT03529435: Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD
Official title: Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
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
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: South Texas Veterans Health Care System
name: C.R.Darnall Army Medical Center
name: Central Texas Veterans Health Care System
name: VISN 17 Center of Excellence
name: University of Pennsylvania
First posted: 2018-05-18
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD symptoms
timeFrame: Baseline to 4 Weeks (Posttreatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Waco
country: United States
facility: Central Texas Veterans Health Care System
state: Texas
Study officials:
affiliation: University of Texas Health Science Center at San Antonio; South Texas Veterans Health Care System
name: Alan L Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.
citation: Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315.
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