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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. Identifier: NCT03663452
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : May 13, 2019
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

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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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Provides behavioral health care to PTSD patients

Exclusion Criteria:

  • Plans to relocate within next 5 months

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Responsible Party: Carmen McLean, Co-Principal Investigator, Palo Alto Veterans Institute for Research Identifier: NCT03663452     History of Changes
Other Study ID Numbers: ROS0029
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders