Clinical trial NCT07010770: SMART Therapist Training: A Hybrid Factorial-SMART Design
Official title: SMART Therapist Training: A Hybrid Factorial-SMART Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Psychotherapy
Keywords: Therapeutics
Psychotherapy
Stress Disorders, Post-Traumatic
Referral and Consultation
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-06-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: All eligible participants will initially be randomized to one of the first-stage tactics:

1. Web-Based Training (WBT) + Consultation with Work-Sample Review (WR)
2. Web-Based Training (WBT) + Standard Consultation
3. Standard Training + Consultation with Work-Sample Review (WR)
4. Standard Training + Standard Consultation

After four months/one completed case, CPT fidelity will be assessed, and therapists who demonstrate inadequate fidelity/cannot be reached for assessment will be classified as demonstrating "fidelity in progress" and will be re-randomized to one of two second-stage tactics for the next two months:

1. Continue in standard consultation
2. Step up to high intensity consultation with biweekly session review.

   Therapists who have achieved fidelity benchmarks will be classified as demonstrating "early fidelity" and will be re-randomized to one of two second-stage tactics for the next two months:
3. Continue in standard consultation
4. Step down to fidelity self-monitoring
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: CPT Therapist Adherence and Competence Scale (TAC)
timeFrame: Baseline (0-months), 6-months, 9-months, and 12-months.
Secondary outcomes:
measure: The Cognitive Therapy Scale-Revised (CTS-R)
timeFrame: Baseline (0-months), 6-months, 9-months, and 12-months.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Rebecca Kaufman Sripada, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: