SMART Therapist Training: A Hybrid Factorial-SMART Design

NCT07010770 | Recruiting DMC

• 2 other identifiers: IIR 24-069HX003943-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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. 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.

Conditions

Stress Disorders, Post-Traumatic; Psychotherapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CPT Therapist Adherence and Competence Scale (TAC)

  The 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.

  Baseline (0-months), 6-months, 9-months, and 12-months.

Secondary Outcomes (1)

• The Cognitive Therapy Scale-Revised (CTS-R)

  Baseline (0-months), 6-months, 9-months, and 12-months.

Study Arms (16)

Condition 1-A

EXPERIMENTAL

Web-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring.

Other: Web-Based Training (WBT); Other: Work Sample Review (WR); Other: Step down to fidelity self-monitoring

Condition 1-B

EXPERIMENTAL

Web-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation.

Other: Web-Based Training (WBT); Other: Work Sample Review (WR)

Condition 1-C

EXPERIMENTAL

Web-Based Training (WBT) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review.

Other: Web-Based Training (WBT); Other: Work Sample Review (WR); Other: Step up to session audio review

Condition 1-D

EXPERIMENTAL

Web-Based Training (WBT) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation.

Other: Web-Based Training (WBT); Other: Work Sample Review (WR); Other: Continue in Standard Consultation

Condition 2-A

EXPERIMENTAL

Web-Based Training (WBT) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring.

Other: Web-Based Training (WBT); Other: Step down to fidelity self-monitoring; Other: Standard Consultation (SC)

Condition 2-B

EXPERIMENTAL

Web-Based Training (WBT) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation.

Other: Web-Based Training (WBT); Other: Standard Consultation (SC)

Condition 2-C

EXPERIMENTAL

Web-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + step up to session audio review.

Other: Web-Based Training (WBT); Other: Step up to session audio review; Other: Standard Consultation (SC)

Condition 2-D

EXPERIMENTAL

Web-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation.

Other: Web-Based Training (WBT); Other: Standard Consultation (SC); Other: Continue in Standard Consultation

Condition 3-A

EXPERIMENTAL

Standard Training (ST) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring.

Other: Work Sample Review (WR); Other: Step down to fidelity self-monitoring; Other: Standard Training (ST)

Condition 3-B

EXPERIMENTAL

Standard Training (ST) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation.

Other: Work Sample Review (WR); Other: Standard Training (ST)

Condition 3-C

EXPERIMENTAL

Standard Training (ST) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review.

Other: Work Sample Review (WR); Other: Step up to session audio review; Other: Standard Training (ST)

Condition 3-D

EXPERIMENTAL

Standard Training (ST) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation.

Other: Work Sample Review (WR); Other: Standard Training (ST); Other: Continue in Standard Consultation

Condition 4-A

EXPERIMENTAL

Standard Training (ST) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring.

Other: Step down to fidelity self-monitoring; Other: Standard Consultation (SC); Other: Standard Training (ST)

Condition 4-B

EXPERIMENTAL

Standard Training (ST) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation.

Other: Standard Consultation (SC); Other: Standard Training (ST); Other: Continue in Standard Consultation

Condition 4-C

EXPERIMENTAL

Standard Training (ST) + Standard Consultation (SC) + fidelity in progress + step up to session audio review.

Other: Step up to session audio review; Other: Standard Consultation (SC); Other: Standard Training (ST)

Condition 4-D

EXPERIMENTAL

Standard Training (ST) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation.

Other: Standard Consultation (SC); Other: Standard Training (ST); Other: Continue in Standard Consultation

Interventions

Web-Based Training (WBT) OTHER

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

Condition 1-A; Condition 1-B; Condition 1-C; Condition 1-D; Condition 2-A; Condition 2-B; Condition 2-C; Condition 2-D

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.

Condition 1-A; Condition 1-B; Condition 1-C; Condition 1-D; Condition 3-A; Condition 3-B; Condition 3-C; Condition 3-D

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.

Condition 1-A; Condition 2-A; Condition 3-A; Condition 4-A

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.

Condition 1-C; Condition 2-C; Condition 3-C; Condition 4-C

Standard Consultation (SC) OTHER

Four months of weekly hour-long group consultation

Condition 2-A; Condition 2-B; Condition 2-C; Condition 2-D; Condition 4-A; Condition 4-B; Condition 4-C; Condition 4-D

Standard Training (ST) OTHER

2-day instructor-led CPT workshop.

Condition 3-A; Condition 3-B; Condition 3-C; Condition 3-D; Condition 4-A; Condition 4-B; Condition 4-C; Condition 4-D

Continue in Standard Consultation OTHER

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

Condition 1-D; Condition 2-D; Condition 3-D; Condition 4-B; Condition 4-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant is not a licensed mental health clinician
• Participant is already certified in CPT

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

RECRUITING

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

RECRUITING

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rebecca Kaufman Sripada, PhD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca K Sripada, PhD MS

CONTACT

(734) 222-7432; rebecca.sripada@va.gov

Isabel Gracy, BS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)