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SMART Therapist Training: A Hybrid Factorial-SMART Design

SMART Therapist Training: A Hybrid Factorial-SMART Design

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07010770
Acronym
SMART
Enrollment
240
Registered
2025-06-08
Start date
2025-08-15
Completion date
2030-08-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotherapy, Stress Disorders, Post-Traumatic

Keywords

Therapeutics, Psychotherapy, Stress Disorders, Post-Traumatic, Referral and Consultation, Veterans

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. The 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.

Interventions

OTHERWeb-Based Training (WBT)

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

OTHERWork 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.

OTHERStep 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.

OTHERStep 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.

OTHERStandard Consultation (SC)

Four months of weekly hour-long group consultation

OTHERStandard Training (ST)

2-day instructor-led CPT workshop.

OTHERContinue in Standard Consultation

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CPT Therapist Adherence and Competence Scale (TAC)Baseline (0-months), 6-months, 9-months, and 12-monthsThe 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

MeasureTime frameDescription
The Cognitive Therapy Scale-Revised (CTS-R)Baseline (0-months), 6-months, 9-months, and 12-monthsThe 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.

Countries

United States

Contacts

CONTACTRebecca K Sripada, PhD MS
rebecca.sripada@va.gov(734) 222-7432
CONTACTIsabel Gracy, BS
PRINCIPAL_INVESTIGATORRebecca Kaufman Sripada, PhD MS

VA Ann Arbor Healthcare System, Ann Arbor, MI

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026