Implementation of Prolonged Exposure in the Military

NCT ID: NCT02982538

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2021-09-30

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard PE Training Condition

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

Group Type: OTHER

Standard Training in Prolonged Exposure Therapy for PTSD

Intervention Type: 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.

Extended PE Training Condition

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.

Group Type: OTHER

Extended Training in Prolonged Exposure Therapy for PTSD

Intervention Type: 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).

Interventions

Extended Training in Prolonged Exposure Therapy for PTSD

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).

Intervention Type: BEHAVIORAL

Standard Training in Prolonged Exposure Therapy for PTSD

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Edna Foa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edna B Foa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Evans Army Community Hospital (EACH), Ft. Carson

Colorado Springs, Colorado, United States

Blanchfield Army Community Hospital (BACH), Ft. Campbell

Fort Campbell North, Kentucky, United States

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

El Paso, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32727509 (View on PubMed)

Other Identifiers

W81XWH-12-2-0116

Identifier Type: -

Identifier Source: org_study_id