SMART Therapist Training: A Hybrid Factorial-SMART Design

Not Applicable

Not yet recruiting

• Conditions: Stress Disorders, Post-Traumatic; Psychotherapy

• Registration Number: NCT07010770
• Lead Sponsor: VA Office of Research and Development

Brief 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. The investigators 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. The investigators 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, the investigators 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. Specific aims are:

* Specific Aim 1: Identify which of two low-intensity training components contribute meaningfully to therapist fidelity. The investigators 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. The investigators 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-07-01
• Primary Completion: 2030-03-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

The investigators have designed the sample to be representative of therapists who are eligible for CPT rollout training.

• Participants must be licensed mental health clinicians or a mental health trainee in VA service (e.g., practicum students, psychology interns, postdoctoral fellows) whose formal job responsibilities include the provision of psychotherapy services to Veterans on a regular basis
• Participants must be able to participate for 9 months.
• Participants must work in a setting where CPT may be implemented (12 weekly 60-minute individual sessions or 90-minute group sessions).
• Participants must have local/supervisor support to implement CPT and fully participate in all training and consultation activities.
• Participating trainees (e.g. psychology interns) on a 6-month training rotation must have permission from their supervisors to continue the study into their next rotation.

Exclusion Criteria

• Participant is not a licensed mental health clinician
• Participant is already certified in CPT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
CPT Therapist Adherence and Competence Scale (TAC)	Baseline (0-months), 6-months, 9-months, and 12-months.	The TAC measures both adherence to specific unique and essential CPT elements, and competence in delivering these interventions.; Adherence is rated on a 3-point Likert-type scale, with 0=incomplete, 1=mostly complete, and 2=fully complete as prescribed in each session.; Competence is rated on a 7-point Likert-type scale, from 0=not competent to 6=outstanding competence. Items rated as a "0" on adherence are automatically rated a "0" for competence. Competence scores between 0 and 2 are cases in which the therapist requires "substantial corrective feedback." Scores between 3 and 4 indicate "acceptable to good; opportunities for feedback," such that the therapist performs the intervention well, but has room for improvement. Scores of 5 and 6 require very little to no feedback.

Secondary Outcome Measures

Name	Time	Method
The Cognitive Therapy Scale-Revised (CTS-R)	Baseline (0-months), 6-months, 9-months, and 12-months.	The CTS-R assesses transdiagnostic CBT specific skills (Guided discovery, Conceptualization, Identifying key cognitions, Application of change methods, Application of behavioral techniques, Homework, and Facilitation of emotional expression) and general therapeutic skills (Agenda, Feedback, Collaboration, Pacing/use of time, and Interpersonal effectiveness). Items are rated on a 0 = incompetent (non-compliance) to 6 = expert (compliance + high skill) scale with item-specific descriptions for each anchor. The range of scores is 0-72.

Trial Locations

Locations (4)

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

Cincinnati VA Medical Center, Cincinnati, OH; 🇺🇸 Cincinnati, Ohio, United States