NCT07010770

SMART Therapist Training: A Hybrid Factorial-SMART Design

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cognitive Processing Therapy (CPT) is highly effective in randomized controlled trials, but its effectiveness drops substantially in standard clinical practice, largely due to therapist "drift" from fidelity to the protocol. What remains unknown is which components of CPT training yield high therapist fidelity. Thus, there is a critical need to use empirical approaches to identify the most effective components of CPT training and to develop an adaptive training model for CPT by testing sequences of empirically-supported training strategies. The long-term goal of this research is to develop a sustainable model of therapy training that is personalized to the needs of the therapist trainee. The overall objective of this application is to empirically optimize an adaptive model for CPT training. The rationale is that developing an adaptive training model will improve efficiency and personalization, yield higher fidelity, and ultimately improve Veteran outcomes. We expect that completion of this project will produce an adaptive CPT training program that yields high therapist fidelity. Improving CPT fidelity in VHA will have a positive impact on the health and wellbeing of Veterans with PTSD.

Detailed description

Background: One third of post-9/11 Veterans in VHA suffer from posttraumatic stress disorder (PTSD), and even among those who receive evidence-based PTSD treatment, over half remain symptomatic. Cognitive Processing Therapy (CPT) is a first-line treatment for PTSD that is initiated three times more frequently than any other trauma-focused treatment. CPT is highly effective in randomized controlled trials, but its effectiveness drops substantially in standard clinical practice, largely due to therapist "drift" from fidelity to the protocol. What remains unknown is which components of CPT training yield high therapist fidelity. Thus, there is a critical need to use empirical approaches to identify the most effective components of CPT training and to develop an adaptive training model for CPT by testing sequences of empirically- supported training strategies. The long-term goal of this research is to develop a sustainable model of therapy training that is personalized to the needs of the therapist trainee. The overall objective of this application is to empirically optimize an adaptive model for CPT training. The rationale is that developing an adaptive training model will improve efficiency and personalization, yield higher fidelity, and ultimately improve Veteran outcomes. We expect that completion of this project will produce an adaptive CPT training program that yields high therapist fidelity. Improving CPT fidelity in VHA will have a positive impact on the health and wellbeing of Veterans with PTSD. Significance: The number of VHA patients with a diagnosis of PTSD has steadily increased for the past 10 years, therefore improving VHA's capacity to deliver PTSD treatment is of utmost importance. This project aligns with the 2024 VHA priorities to connect Veterans to the best care and improve VHA workforce retention. Innovation \& Impact: Upon successful completion of this project, we expect to contribute an empirically-based, adaptive training model for CPT. This contribution will improve therapist fidelity to CPT and ultimately yield superior clinical outcomes for Veterans with PTSD. The research is innovative because it will use a novel, highly efficient experimental design to shift the current CPT training paradigm from fixed, hard-to-scale strategies to a dynamic and accessible approach, composed of empirically-based components. Our specific aims are: * Specific Aim 1: Identify which of two low-intensity training components contribute meaningfully to therapist fidelity. We will test the effectiveness of each component and their interaction, as measured by therapist fidelity ratings across 12 months. * Specific Aim 2: For those with "fidelity in progress," determine whether stepping up to high-intensity consultation improves fidelity. We hypothesize that stepping up will lead to greater fidelity. * Exploratory Aims: A) For those with "early fidelity," assess the impact of stepping down to self-monitoring versus continuing in standard consultation. B) Compare standard training and consultation to the embedded adaptive training strategies. C) Identify moderators. D) Conduct cost analysis and refine the program through process evaluation. Methodology: This Hybrid Factorial-SMART will determine which of two low-intensity components (Web-based Training or Consultation Work-Sample Review) is most effective during the initial phase of CPT training. Those who have reached fidelity benchmarks at Month 4 ("early fidelity") will be re-randomized to Continue with standard consultation or Step Down to fidelity self-monitoring. Those not reaching fidelity at Month 4 ("fidelity in progress") will be re- randomized to Continue or Step Up to high-intensity consultation. Fidelity will be assessed by trained evaluators at baseline, 6, 9, \& 12 months via standardized patient exercise.

Conditions

• Stress Disorders, Post-Traumatic
• Psychotherapy

Interventions

Type	Name	Description
OTHER	Web-Based Training (WBT)	A self-paced online training course that includes video demonstrations, self-guided modules, and clinical materials/resources.
OTHER	Work Sample Review (WR)	Four months of weekly hour-long consultation that will include trainer-led reviews of work samples, focusing on the Impact Statement and Stuck Point Log.
OTHER	Step down to fidelity self-monitoring	After four months, and for participants who are classified as meeting "early fidelity", for the next two months, therapists in self-monitored fidelity will no longer attend group consultation. Instead, they will assess their own fidelity through self-report surveys.
OTHER	Step up to session audio review	After four months, and for participants who are classified as meeting "fidelity in progress", for the next two months, therapists will have their session audio recordings reviewed and rated for fidelity.
OTHER	Standard Consultation (SC)	Four months of weekly hour-long group consultation
OTHER	Standard Training (ST)	2-day instructor-led CPT workshop.
OTHER	Continue in Standard Consultation	After four months, therapists will continue to attend weekly hour-long group consultation for another two months.

Timeline

• Start date: 2025-08-15
• Primary completion: 2030-05-31
• Completion: 2030-08-30
• First posted: 2025-06-08
• Last updated: 2025-09-02

Locations

4 sites across 1 country: United States