NCT03663452

Brief Summary

This study will evaluate a program designed to increase military treatment facilities' use of Prolonged Exposure (PE), an evidence-based psychotherapy for PTSD. The results will determine whether this program increases PE use and improves patient outcomes compared to conventional provider training in PE, and feedback from clinic leaders and staff will be used to gauge program usability, identify successful components, and refine program for expansion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

September 4, 2018

Last Update Submit

August 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • PE use

    The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data

    Baseline to 20 months

Secondary Outcomes (1)

  • Change in patients' PTSD severity

    Baseline to 20 months

Other Outcomes (1)

  • TACTICS usability and satisfaction

    Immediately after the 5-month TACTICS intervention

Study Arms (2)

Prolonged exposure training

ACTIVE COMPARATOR
Behavioral: Prolonged exposure training

TACTICS

EXPERIMENTAL
Behavioral: Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS)

Interventions

TACTICS begins with a mixed methods assessment (using data from medical records, staff surveys, and staff interviews) to identify barriers and facilitators of PE use in each clinic. From a menu of implementation strategies that can be matched to local conditions, an implementation plan is developed in collaboration with clinic personnel and deployed to address specific barriers and leverage strengths at each clinic site over a 5-month period.

TACTICS

Providers will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation.

Prolonged exposure training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Provides behavioral health care to PTSD patients

You may not qualify if:

  • Plans to relocate within next 5 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Bassett Army Community Hospital / Ft. Wainwright

Fairbanks, Alaska, 99703, United States

Location

Mental Health Clinic / Travis Air Force Base

Fairfield, California, 94535, United States

Location

Naval Hospital Jacksonville / Naval Air Station Jacksonville

Jacksonville, Florida, 32214, United States

Location

Blanchfield Army Community Hospital (BACH) / Fort Campbell

Fort Campbell North, Kentucky, 42223, United States

Location

81st Medical Group / Keesler Air Force Base

Biloxi, Mississippi, 39530, United States

Location

49th Medical Group / Holloman Air Force Base

Alamogordo, New Mexico, 88330, United States

Location

William Beaumont Army Medical Center (WBAMC) / Fort Bliss

El Paso, Texas, 79920, United States

Location

Brooke Army Medical Center (BAMC) / Fort Sam Houston

San Antonio, Texas, 78234, United States

Location

Related Publications (1)

  • Rosen CS, Davis CA, Riggs D, Cook J, Peterson AL, Young-McCaughan S, Comtois KA, Haddock CK, Borah EV, Dondanville KA, Finley EP, Jahnke SA, Poston WSC, Wiltsey-Stirman S, Neitzer A, Broussard CR, Brzuchalski MA, Clayton MSP, Conforte LAM, Flores A, Hein J, Keith CF, Jinkerson CJ, Letendre M, Nofziger D, Pollick K, Santiago CK, Waggoner LCJ, Woodworth C, McLean CP; TACTICS Research Group. Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study. Contemp Clin Trials. 2020 Jun;93:106008. doi: 10.1016/j.cct.2020.106008. Epub 2020 Apr 21.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Carmen McLean, PhD

    carmen.mclean4@va.gov

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: This project will use a cluster-randomized stepped wedge design in eight MHS behavioral health outpatient clinics. All sites first receive PE training, and are randomly allocated to receive the TACTICS intervention either 5, 10, or 15 months later.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 10, 2018

Study Start

January 10, 2019

Primary Completion

February 1, 2023

Study Completion

September 1, 2023

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations