SMART Therapist Training: A Hybrid Factorial-SMART Design
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT07010770
- Status
- Recruiting
Conditions
- Psychotherapy
- Stress Disorders, Post-Traumatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Web-Based Training (WBT) — OTHERA self-paced online training course that includes video demonstrations, self-guided modules, and clinical materials/resources.
- Work Sample Review (WR) — OTHERFour 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 — OTHERAfter 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 — OTHERAfter 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) — OTHERFour months of weekly hour-long group consultation
- Standard Training (ST) — OTHER2-day instructor-led CPT workshop.
- Continue in Standard Consultation — OTHERAfter four months, therapists will continue to attend weekly hour-long group consultation for another two months.
Study Details
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.
Key Dates
- Start date
- Aug 15, 2025
- Status verified
- Aug 2025
- Primary completion
- May 31, 2030
- Completion
- Aug 30, 2030
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- OTHER
Arms
- Experimental: Condition 1-AWeb-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring.
- Experimental: Condition 1-BWeb-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation.
- Experimental: Condition 1-CWeb-Based Training (WBT) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review.
- Experimental: Condition 1-DWeb-Based Training (WBT) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation.
- Experimental: Condition 2-AWeb-Based Training (WBT) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring.
- Experimental: Condition 2-BWeb-Based Training (WBT) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation.
- Experimental: Condition 2-CWeb-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + step up to session audio review.
- Experimental: Condition 2-DWeb-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation.
- Experimental: Condition 3-AStandard Training (ST) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring.
- Experimental: Condition 3-BStandard Training (ST) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation.
- Experimental: Condition 3-CStandard Training (ST) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review.
- Experimental: Condition 3-DStandard Training (ST) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation.
- Experimental: Condition 4-AStandard Training (ST) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring.
- Experimental: Condition 4-BStandard Training (ST) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation.
- Experimental: Condition 4-CStandard Training (ST) + Standard Consultation (SC) + fidelity in progress + step up to session audio review.
- Experimental: Condition 4-DStandard Training (ST) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation.
Primary Outcome Measure
CPT Therapist Adherence and Competence Scale (TAC) [ Time Frame: Baseline (0-months), 6-months, 9-months, and 12-months. ]
Central Contacts
- Rebecca K Sripada, PhD MS(734) 222-7432
- Isabel Gracy, BS
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105-2303 | Rebecca Kaufman Sripada, PhD MS (PRINCIPAL_INVESTIGATOR) |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | |
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220-2213 |
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