Clinical trial NCT02982538: Implementation of Prolonged Exposure in the Military
Official title: Implementation of Prolonged Exposure in the Army: Is Consultation Necessary for Effective Dissemination?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: posttraumatic stress symptoms
implementation
dissemination
PTSD
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2016-12-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized study examines how prolonged exposure (PE) therapy, an evidence-based treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and implemented in the Army. The study compares two PE training models: Standard PE training, comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop plus expert case consultation. In addition, patients with posttraumatic stress symptoms receiving psychotherapy from participating providers will be invited to participate. After completing PE training, use of PE components with patients reporting PTS symptoms and clinical outcomes of these participating patients will be monitored for up to 18 months.

Detailed description: This study will examine how evidence-based therapies (EBTs) such as Prolonged Exposure (PE) for posttraumatic stress disorder (PTSD) can be successfully disseminated and implemented in the Army by comparing two PE training models: Standard PE training (workshop only) and Extended PE training (workshop plus consultation). Up to 180 mental health providers at three medium-to large Army installations will be randomly assigned to either Standard PE training or Extended PE training. All providers will complete a 4-day PE workshop, along with the distribution of training materials and treatment manuals, conducted at the military site by the Overall Study PI, Dr. Edna Foa, and her team. Following the 4-day workshop, participants randomized to the Extended PE training will receive weekly phone consultation with a PE expert on two PE therapy cases. Participants randomized to the Standard PE training group will not receive any additional consultation following the workshop. Providers will not be required to use PE therapy with their patients with PTS symptoms; using PE will be optional. A major outcome of this study is the proportion of the providers PTSD patients that are offered PE or PE components. The mental health outcomes of providers' PTS patients will also be monitored as a second major outcome. Patients seeking treatment from participating providers will be recruited, consented, and assessed by independent evaluators at two time points to prospectively assess their response to treatment.

Eligibility criteria: Inclusion Criteria:

* FOR PROVIDERS: 1) Male and female behavioral health providers whose job duties include providing psychotherapy to adult patients, age ≥ 18,seeking treatment with symptoms of PTS. Behavioral health providers can include psychologists, social workers, psychiatric clinical nurse specialists, psychiatrists, and similarly trained professional providers.2) Twenty percent (or more) of expected caseload comprised of patients with PTS symptoms according to provider self-report.
* FOR PATIENTS: 1) Male and female patients age ≥ 18. 2) Receiving treatment from one of the behavioral health providers participating in this study. 3) Significant PTS symptoms as determined by a score of 25 or higher on The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

Exclusion Criteria:

* FOR PROVIDERS: 1) Definite plans to terminate their position or relocate from the Army base at some point during the first year following training. 2) Extensive previous training in Prolonged Exposure (PE), defined as participation in a 4-day PE training workshop at any point prior to the start of the study, and self-reported use of PE (including both imaginal and in vivo exposure techniques) to treat 4 or more patients with PTS symptoms in the past year.
* FOR PATIENTS: 1) Current bipolar disorder I or psychotic disorder (as determined by the MINI). 2) Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires). 3) Current suicidal ideation severe enough to warrant immediate attention (as determined by the MINI and the Beck Scale for Suicidal Ideation).

Primary outcomes:
measure: Provider Use of PE Components
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Provider Attitudes
timeFrame: Through study completion, an average of 2 years
measure: Patient Posttraumatic Stress Outcomes
timeFrame: 8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Evans Army Community Hospital (EACH), Ft. Carson
state: Colorado
city: Fort Campbell North
country: United States
facility: Blanchfield Army Community Hospital (BACH), Ft. Campbell
state: Kentucky
city: El Paso
country: United States
facility: William Beaumont Army Medical Center (WBAMC), Ft. Bliss
state: Texas
Study officials:
affiliation: University of Pennsylvania
name: Edna B Foa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foa EB, McLean CP, Brown LA, Zang Y, Rosenfield D, Zandberg LJ, Ealey W, Hanson BS, Hunter LR, Lillard IJ, Patterson TJ, Rosado J, Scott V, Weber C, Wise JE, Zamora CD, Mintz J, Young-McCaughan S, Peterson AL; STRONG STAR Consortium. The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Implement Sci. 2020 Jul 29;15(1):59. doi: 10.1186/s13012-020-01014-x.