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SMART Therapist Training: A Hybrid Factorial-SMART Design

VA Office of Research and Development logo

VA Office of Research and Development

Status

Begins enrollment this month

Conditions

Psychotherapy
Stress Disorders, Post-Traumatic

Treatments

Other: Standard Consultation (SC)
Other: Step down to fidelity self-monitoring
Other: Work Sample Review (WR)
Other: Continue in Standard Consultation
Other: Standard Training (ST)
Other: Web-Based Training (WBT)
Other: Step up to session audio review

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07010770
IIR 24-069
HX003943-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

240 participants in 16 patient groups

Condition 1-A
Experimental group
Description:
Web-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring.
Treatment:
Other: Web-Based Training (WBT)
Other: Work Sample Review (WR)
Other: Step down to fidelity self-monitoring
Condition 1-B
Experimental group
Description:
Web-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation.
Treatment:
Other: Web-Based Training (WBT)
Other: Work Sample Review (WR)
Condition 1-C
Experimental group
Description:
Web-Based Training (WBT) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review.
Treatment:
Other: Step up to session audio review
Other: Web-Based Training (WBT)
Other: Work Sample Review (WR)
Condition 1-D
Experimental group
Description:
Web-Based Training (WBT) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation.
Treatment:
Other: Web-Based Training (WBT)
Other: Continue in Standard Consultation
Other: Work Sample Review (WR)
Condition 2-A
Experimental group
Description:
Web-Based Training (WBT) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring.
Treatment:
Other: Web-Based Training (WBT)
Other: Step down to fidelity self-monitoring
Other: Standard Consultation (SC)
Condition 2-B
Experimental group
Description:
Web-Based Training (WBT) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation.
Treatment:
Other: Web-Based Training (WBT)
Other: Standard Consultation (SC)
Condition 2-C
Experimental group
Description:
Web-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + step up to session audio review.
Treatment:
Other: Step up to session audio review
Other: Web-Based Training (WBT)
Other: Standard Consultation (SC)
Condition 2-D
Experimental group
Description:
Web-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation.
Treatment:
Other: Web-Based Training (WBT)
Other: Continue in Standard Consultation
Other: Standard Consultation (SC)
Condition 3-A
Experimental group
Description:
Standard Training (ST) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring.
Treatment:
Other: Standard Training (ST)
Other: Work Sample Review (WR)
Other: Step down to fidelity self-monitoring
Condition 3-B
Experimental group
Description:
Standard Training (ST) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation.
Treatment:
Other: Standard Training (ST)
Other: Work Sample Review (WR)
Condition 3-C
Experimental group
Description:
Standard Training (ST) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review.
Treatment:
Other: Step up to session audio review
Other: Standard Training (ST)
Other: Work Sample Review (WR)
Condition 3-D
Experimental group
Description:
Standard Training (ST) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation.
Treatment:
Other: Standard Training (ST)
Other: Continue in Standard Consultation
Other: Work Sample Review (WR)
Condition 4-A
Experimental group
Description:
Standard Training (ST) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring.
Treatment:
Other: Standard Training (ST)
Other: Step down to fidelity self-monitoring
Other: Standard Consultation (SC)
Condition 4-B
Experimental group
Description:
Standard Training (ST) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation.
Treatment:
Other: Standard Training (ST)
Other: Continue in Standard Consultation
Other: Standard Consultation (SC)
Condition 4-C
Experimental group
Description:
Standard Training (ST) + Standard Consultation (SC) + fidelity in progress + step up to session audio review.
Treatment:
Other: Step up to session audio review
Other: Standard Training (ST)
Other: Standard Consultation (SC)
Condition 4-D
Experimental group
Description:
Standard Training (ST) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation.
Treatment:
Other: Standard Training (ST)
Other: Continue in Standard Consultation
Other: Standard Consultation (SC)

Trial contacts and locations

4

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Central trial contact

Isabel Gracy, BS; Rebecca K Sripada, PhD MS

Data sourced from clinicaltrials.gov

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