Implementation of Prolonged Exposure in the Military

NCT02982538 | Completed

• 1 other identifier: W81XWH-12-2-0116
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

PTSD

Keywords

posttraumatic stress symptoms; implementation; dissemination; PTSD

Outcome Measures

Primary Outcomes (1)

• Provider Use of PE Components

  Provider use of PE components will be assessed using a brief checklist of treatment procedures completed by providers directly following therapy sessions with participating patients.

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Provider Attitudes

  Through study completion, an average of 2 years

• Patient Posttraumatic Stress Outcomes

  8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first

Study Arms (2)

Standard PE Training Condition

OTHER

Providers in this condition will complete a 4-day training workshop in PE.

Behavioral: Standard Training in Prolonged Exposure Therapy for PTSD

Extended PE Training Condition

OTHER

Providers in this condition will complete a 4-day training workshop in PE and will receive expert PE case consultation on two PE training cases via weekly phone consultation.

Behavioral: Extended Training in Prolonged Exposure Therapy for PTSD

Interventions

Extended Training in Prolonged Exposure Therapy for PTSD BEHAVIORAL

Extended training in Prolonged Exposure consists of a 4-day PE workshop, followed by expert PE consultation on 2 training cases. PE consultation consists of weekly telephone calls with expert PE therapists at the University of Pennsylvania, who will review video-recordings of providers PE sessions and provide feedback. Consultation is considered complete if the consultant has reviewed a minimum of 12 video-recorded sessions across 2 training cases, and has provided feedback on all of the crucial elements of PE (e.g., rationale, imaginal exposure, in vivo exposure, processing).

Extended PE Training Condition

Standard Training in Prolonged Exposure Therapy for PTSD BEHAVIORAL

Standard training in PE consists of a 4-day professional workshop on Prolonged Exposure Therapy. This is similar to the standard training approach that has been used to train providers in delivery of PE in the Army.

Standard PE Training Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Texas: collaborator

Study Sites (3)

Evans Army Community Hospital (EACH), Ft. Carson

Colorado Springs, Colorado, 80913, United States

Location

Blanchfield Army Community Hospital (BACH), Ft. Campbell

Fort Campbell North, Kentucky, 42223, United States

Location

William Beaumont Army Medical Center (WBAMC), Ft. Bliss

El Paso, Texas, 79906, United States

Location

Related Publications (1)

• 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.

  PMID: 32727509 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Edna B Foa, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: December 5, 2016
• Study Start: October 1, 2012
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)