Posttraumatic Stress DisorderNCT03663452
Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings
A study testing Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) and Prolonged exposure training in people with Posttraumatic Stress Disorder, run by Palo Alto Veterans Institute for Research at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) and Prolonged exposure training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jan 2019to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provides behavioral health care to PTSD patients
Who cannot join
- Plans to relocate within next 5 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
49th Medical Group / Holloman Air Force Base
Alamogordo, New Mexico, 88330
81st Medical Group / Keesler Air Force Base
Biloxi, Mississippi, 39530
William Beaumont Army Medical Center (WBAMC) / Fort Bliss
El Paso, Texas, 79920
Bassett Army Community Hospital / Ft. Wainwright
Fairbanks, Alaska, 99703
Mental Health Clinic / Travis Air Force Base
Fairfield, California, 94535
Blanchfield Army Community Hospital (BACH) / Fort Campbell
Fort Campbell North, Kentucky, 42223
Naval Hospital Jacksonville / Naval Air Station Jacksonville
Jacksonville, Florida, 32214
Brooke Army Medical Center (BAMC) / Fort Sam Houston
San Antonio, Texas, 78234
About this study
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.
Read the detailed description
Background: Posttraumatic stress disorder (PTSD) is a significant problem in the military, impacting as many as 1 in 5 military personnel. Efforts to disseminate evidence-based treatments for PTSD such as Prolonged Exposure (PE) therapy throughout the Military Health System (MHS) have relied primarily on provider training. These have yielded mixed results, because they do not directly address barriers that may prevent providers from using a new treatment after they gave been trained in it. Barriers to using PE within the MHS are complex and exist at various levels of organization from the provider level to the "outer context" (i.e., higher headquarter policies, guidelines). In addition, barriers may vary considerably from one military treatment facility to another. Thus, implementation strategies to improve use of PE need to be tailored to conditions in each clinic site.
Objectives: The primary objective is to develop and implement a novel approach, Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS), to improve the implementation of PE and to test its impact on care over and above clinician training only. TACTICS provides a menu of implementation strategies that can be matched to local conditions. These strategies are informed by the implementation science literature and by prior experience working with military clinics, The TACTICS process 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. Implementation strategies are then selected in collaboration with clinic personnel and deployed to address specific barriers and leverage strengths at each clinic site.
Specific Aims: 1) To examine the impact of a multi-modal, tailored approach (TACTICS) over and above conventional PE training on the proportion of PTSD patients who receive PE for PTSD, as measured by Natural Language Processing (NLP) of psychotherapy progress notes (primary measure) and clinician-selected psychotherapy modality (secondary measure). 2) To examine the impact of TACTICS over and above conventional PE training on mean improvement in Military Treatment Facility (MTF) clinic patients' scores on the PTSD Checklist (PCL) for DSM-5 (fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, PCL-5). 3) To evaluate the usability of and overall satisfaction with TACTICS among senior leaders, clinic leaders, and providers, as assessed by qualitative data obtained from the post-TACTICS feedback interviews. The study will also aim to identify TACTICS components that a) were seen as most useful by participants and appear to contribute to implementation success; b) are potentially helpful but require modifications; and c) are potentially unnecessary and do not appear to contribute to implementation success. Exploratory aims include: A) To assess the impact of TACTICS (over and above PE training) on provider and clinic-level factors theorized to facilitate implementation in the Consolidated Framework for Implementation Research (CFIR). These proximal factors include changes in provider knowledge/beliefs about PE, provider self-efficacy, burnout, implementation climate, and leadership engagement, as assessed through online surveys. B) To explore whether changes in additional CFIR-theorized provider- and clinic-level factors (based on emergent themes in qualitative needs assessment interviews and exit interviews) are associated with greater improvements in reach (i.e., a greater number of patients receiving PE) and effectiveness (i.e., greater improvement in PTSD symptoms as measured by the PCL-5). C) To examine the TACTICS implementation strategies employed at each site in connection with increase in PE receipt, to determine whether any particular strategies had a positive or negative impact on PE receipt. D) To evaluate the impact of TACTICS over and above conventional PE training on self-reported levels of PE fidelity, as measured by NLP data of psychotherapy progress notes. E) To examine patient characteristics (e.g., depression, generalized anxiety, recent hospitalizations, other psychiatric diagnoses) that may be associated with PE receipt.
Study Design. This project will use a cluster-randomized stepped wedge design in eight MHS behavioral health outpatient clinics. Randomization will occur at the clinic level to account for the clustering of providers within clinics. All clinics receive the whole intervention package, but timing is randomly assigned. Participants will include the behavioral health providers and relevant clinic and hospital leadership. During a baseline phase, provider training in PE will be delivered. During the second phase, a clinic-based needs assessment will be conducted followed by the implement of TACTICS components. Selection of implementation strategies will be guided by the results of the needs assessments and well-established implementation science frameworks. Results of the second phase will determine the impact of TACTICS over and above clinician training.
Significance. Accelerating the use of PE for PTSD within the MHS will increase the number of service members in need who can access, and hopefully benefit, from an effective PTSD treatment. In turn, as more patients recover successfully, behavioral health clinic capacity will increase and more service members will receive care. The project will identify solutions for the unique challenges to implementation of PE in the MHS, and, if effective, TACTICS may represent a scalable approach to accelerating the use of other behavioral health best practices in military settings
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS), Prolonged exposure training
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS)Behavioural
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.
Prolonged exposure trainingBehavioural
Providers will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged exposure training | Active comparator | Not described Receives: Behavioral: Prolonged exposure training |
| TACTICS | Experimental | Not described Receives: Behavioral: Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PE use
The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data
Measured: Baseline to 20 months
Secondary outcomes (1)
Change in patients' PTSD severity
Patients' PTSD symptoms, as measured by change on a PTSD symptom measure routinely collected at behavioral health appointments.
Measured: Baseline to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start10 Jan 2019
- Primary completion1 Feb 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Carmen McLean, Palo Alto Veterans Institute for Research
- Investigators
- Carmen McLean, PhD, Principal investigator, carmen.mclean4@va.gov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663452
- Sponsor's protocol ID
- ROS0029
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2018
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32330670
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings
- ClinicalTrials.gov ID
- NCT03663452
- Acronym / sponsor ID
- ROS0029
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Posttraumatic stress disorder (PTSD) is a significant problem in the military, impacting as many as 1 in 5 military personnel. Efforts to disseminate evidence-based treatments for PTSD such as Prolonged Exposure (PE) therapy throughout the Military Health System (MHS) have relied primarily on provider training. These have yielded mixed results, because they do not directly address barriers that may prevent providers from using a new treatment after they gave been trained in it. Barriers to using PE within the MHS are complex and exist at various levels of organization from the provider level to the "outer context" (i.e., higher headquarter policies, guidelines). In addition, barriers may vary considerably from one military treatment facility to another. Thus, implementation strategies to improve use of PE need to be tailored to conditions in each clinic site.
Objectives: The primary objective is to develop and implement a novel approach, Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS), to improve the implementation of PE and to test its impact on care over and above clinician training only. TACTICS provides a menu of implementation strategies that can be matched to local conditions. These strategies are informed by the implementation science literature and by prior experience working with military clinics, The TACTICS process 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. Implementation strategies are then selected in collaboration with clinic personnel and deployed to address specific barriers and leverage strengths at each clinic site.
Specific Aims: 1) To examine the impact of a multi-modal, tailored approach (TACTICS) over and above conventional PE training on the proportion of PTSD patients who receive PE for PTSD, as measured by Natural Language Processing (NLP) of psychotherapy progress notes (primary measure) and clinician-selected psychotherapy modality (secondary measure). 2) To examine the impact of TACTICS over and above conventional PE training on mean improvement in Military Treatment Facility (MTF) clinic patients' scores on the PTSD Checklist (PCL) for DSM-5 (fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, PCL-5). 3) To evaluate the usability of and overall satisfaction with TACTICS among senior leaders, clinic leaders, and providers, as assessed by qualitative data obtained from the post-TACTICS feedback interviews. The study will also aim to identify TACTICS components that a) were seen as most useful by participants and appear to contribute to implementation success; b) are potentially helpful but require modifications; and c) are potentially unnecessary and do not appear to contribute to implementation success. Exploratory aims include: A) To assess the impact of TACTICS (over and above PE training) on provider and clinic-level factors theorized to facilitate implementation in the Consolidated Framework for Implementation Research (CFIR). These proximal factors include changes in provider knowledge/beliefs about PE, provider self-efficacy, burnout, implementation climate, and leadership engagement, as assessed through online surveys. B) To explore whether changes in additional CFIR-theorized provider- and clinic-level factors (based on emergent themes in qualitative needs assessment interviews and exit interviews) are associated with greater improvements in reach (i.e., a greater number of patients receiving PE) and effectiveness (i.e., greater improvement in PTSD symptoms as measured by the PCL-5). C) To examine the TACTICS implementation strategies employed at each site in connection with increase in PE receipt, to determine whether any particular strategies had a positive or negative impact on PE receipt. D) To evaluate the impact of TACTICS over and above conventional PE training on self-reported levels of PE fidelity, as measured by NLP data of psychotherapy progress notes. E) To examine patient characteristics (e.g., depression, generalized anxiety, recent hospitalizations, other psychiatric diagnoses) that may be associated with PE receipt.
Study Design. This project will use a cluster-randomized stepped wedge design in eight MHS behavioral health outpatient clinics. Randomization will occur at the clinic level to account for the clustering of providers within clinics. All clinics receive the whole intervention package, but timing is randomly assigned. Participants will include the behavioral health providers and relevant clinic and hospital leadership. During a baseline phase, provider training in PE will be delivered. During the second phase, a clinic-based needs assessment will be conducted followed by the implement of TACTICS components. Selection of implementation strategies will be guided by the results of the needs assessments and well-established implementation science frameworks. Results of the second phase will determine the impact of TACTICS over and above clinician training.
Significance. Accelerating the use of PE for PTSD within the MHS will increase the number of service members in need who can access, and hopefully benefit, from an effective PTSD treatment. In turn, as more patients recover successfully, behavioral health clinic capacity will increase and more service members will receive care. The project will identify solutions for the unique challenges to implementation of PE in the MHS, and, if effective, TACTICS may represent a scalable approach to accelerating the use of other behavioral health best practices in military settings
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prolonged exposure training | Active comparator | Behavioral: Prolonged exposure training |
| TACTICS | Experimental | Behavioral: Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Provides behavioral health care to PTSD patients
Key exclusion criteria (1 listed)
- Plans to relocate within next 5 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TACTICS |
| Prolonged exposure trainingProviders will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation. | Behavioural | Prolonged exposure training |
Primary outcome
PE use
Time frame: Baseline to 20 months
The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data
1 secondary outcome
Change in patients' PTSD severity
Time frame: Baseline to 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 32330670Rosen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen McLean, PhD principal investigator
carmen.mclean4@va.gov
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) and Prolonged exposure training in people with Posttraumatic Stress Disorder, run by Palo Alto Veterans Institute for Research at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PE use (time frame: Baseline to 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.