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NCT Number: NCT07010770

SMART Therapist Training: A Hybrid Factorial-SMART Design

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

We 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

Treatment and study plan

Web-Based Training (WBT)

Other

A self-paced online training course that includes video demonstrations, self-guided modules, and clinical materials/resources.

Work Sample Review (WR)

Other

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.

Step down to fidelity self-monitoring

Other

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.

Step up to session audio review

Other

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.

Standard Consultation (SC)

Other

Four months of weekly hour-long group consultation

Standard Training (ST)

Other

2-day instructor-led CPT workshop.

Continue in Standard Consultation

Other

After four months, therapists will continue to attend weekly hour-long group consultation for another two months.

Primary outcomes

  1. CPT Therapist Adherence and Competence Scale (TAC)

    Time frame: 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 outcomes

  1. The Cognitive Therapy Scale-Revised (CTS-R)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Gracy, BS

CONTACT

Rebecca K Sripada, PhD MS

CONTACT

[email protected]

(734) 222-7432

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: SMART

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 8, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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