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) — 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.

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

Locations (4)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Shannon Wiltsey-Stirman, PhD
650-493-5000
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Michael P Robertson
(734) 845-5718
Fatima Makki, MPH MSW
(734) 845-3623
Rebecca Kaufman Sripada, PhD MS (PRINCIPAL_INVESTIGATOR)
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesota55417-2309
Nina Sayer, PhD
612-725-2000
Robert Orazem, PhD
6126297453
Cincinnati VA Medical Center, Cincinnati, OHCincinnatiOhio45220-2213
Kathleen Chard, PhD
513-861-3100

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