Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663452
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Carmen McLean, Palo Alto Veterans Institute for Research

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) Behavioral: Prolonged exposure training Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Active Comparator: Prolonged exposure training Behavioral: Prolonged exposure training
Providers will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation.

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




Primary Outcome Measures :
  1. PE use [ Time Frame: Baseline to 20 months ]
    The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data


Secondary Outcome Measures :
  1. Change in patients' PTSD severity [ Time Frame: Baseline to 20 months ]
    Patients' PTSD symptoms, as measured by change on a PTSD symptom measure routinely collected at behavioral health appointments.


Other Outcome Measures:
  1. TACTICS usability and satisfaction [ Time Frame: Immediately after the 5-month TACTICS intervention ]
    Usability of and overall satisfaction with TACTICS among senior leaders, clinic leaders, and providers, as assessed through post-TACTICS qualitative interviews.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provides behavioral health care to PTSD patients

Exclusion Criteria:

  • Plans to relocate within next 5 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663452


Contacts
Layout table for location contacts
Contact: Carmen McLean, PhD 650-614-9997 ext 26384 carmen.mclean4@va.gov
Contact: Andrea Neitzer Andrea.Neitzer@va.gov

Locations
Layout table for location information
United States, Alaska
Bassett Army Community Hospital / Ft. Wainwright Not yet recruiting
Fairbanks, Alaska, United States, 99703
Contact: Margaret Letendre         
United States, California
Mental Health Clinic / Travis Air Force Base Not yet recruiting
Fairfield, California, United States, 94535
Contact: Erik Ringdahl         
United States, Florida
Naval Hospital Jacksonville / Naval Air Station Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32214
Contact: Allison Conforte         
United States, Kentucky
Blanchfield Army Community Hospital (BACH) / Fort Campbell Recruiting
Fort Campbell North, Kentucky, United States, 42223
Contact: Ross A Everhard         
United States, Mississippi
81st Medical Group / Keesler Air Force Base Not yet recruiting
Biloxi, Mississippi, United States, 39530
Contact: Jeremy Jinkerson         
United States, New Mexico
49th Medical Group / Holloman Air Force Base Not yet recruiting
Alamogordo, New Mexico, United States, 88330
Contact: Kyra Santiago         
United States, Texas
William Beaumont Army Medical Center (WBAMC) / Fort Bliss Not yet recruiting
El Paso, Texas, United States, 79920
Contact: Amy Brzuchalski         
Brooke Army Medical Center (BAMC) / Fort Sam Houston Recruiting
San Antonio, Texas, United States, 78234
Contact: Craig Woodworth         
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Carmen McLean, PhD carmen.mclean4@va.gov
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Carmen McLean, Co-Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03663452    
Other Study ID Numbers: ROS0029
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders