Stress Disorders, Post-TraumaticSMARTNCT07010770
SMART Therapist Training: A Hybrid Factorial-SMART Design
A study testing Web-Based Training (WBT), Work Sample Review (WR) and Step down to fidelity self-monitoring in people with Stress Disorders, Post-Traumatic and Psychotherapy, run by VA Office of Research and Development at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Psychotherapy
- What is being tested?
- Web-Based Training (WBT), Work Sample Review (WR) and Step down to fidelity self-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Aug 2025to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participant is not a licensed mental health clinician
- Participant is already certified in CPT
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Isabel Gracy, BS contact
United States4 sites, 4 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Michael P Robertson, (734) 845-5718, Michael.Robertson6@va.gov
Fatima Makki, MPH MSW, (734) 845-3623, fatima.makki@va.gov
- Recruiting
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
Kathleen M Chard, PhD, 513-861-3100 ext. 6741, kathleen.chard@va.gov
Kathleen M Chard, PhD
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Nina Sayer, PhD, 612-725-2000 ext. 314623, nina.sayer@va.gov
Robert Orazem, PhD, 6126297453, robert.orazem2@va.gov
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Shannon Wiltsey Stirman, PhD, 650-493-5000 ext. 20007, Shannon.Wiltsey-Stirman@va.gov
Shannon Wiltsey Stirman, PhD
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Psychotherapy
- Being tested
- Web-Based Training (WBT), Work Sample Review (WR), Step down to fidelity self-monitoring, Step up to session audio review, Standard Consultation (SC)
- Keywords
- Therapeutics, Psychotherapy, Stress Disorders, Post-Traumatic, Referral and Consultation, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-monitoringOther
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 reviewOther
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 ConsultationOther
After four months, therapists will continue to attend weekly hour-long group consultation for another two months.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1-A | Experimental | Web-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Standard Consultation (SC); Other: Standard Training (ST); Other: Continue in Standard Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0-months), 6-months, 9-months, and 12-months
Secondary outcomes (1)
The Cognitive Therapy Scale-Revised (CTS-R)
The 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.
Measured: Baseline (0-months), 6-months, 9-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start15 Aug 2025
- Primary completion31 May 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca Kaufman Sripada, PhD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010770
- Sponsor's protocol ID
- IIR 24-069
- Other IDs
- HX003943-01
- Acronym
- SMART
- Status last verified
- Jul 2026
- First submitted
- 30 May 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Therapist Training: A Hybrid Factorial-SMART Design
- ClinicalTrials.gov ID
- NCT07010770
- Acronym / sponsor ID
- SMART / IIR 24-069
- Conditions
- Stress Disorders, Post-Traumatic, Psychotherapy
- Keywords
- Therapeutics, Psychotherapy, Stress Disorders, Post-Traumatic, Referral and Consultation, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- 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
| Arm | Type | Receives |
|---|---|---|
| Condition 1-A | Experimental | Other: Web-Based Training (WBT), Other: Work Sample Review (WR), Other: Step down to fidelity self-monitoringWeb-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring. |
| Condition 1-B | Experimental | Other: Web-Based Training (WBT), Other: Work Sample Review (WR)Web-Based Training (WBT) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation. |
| Condition 1-C | Experimental | Other: Web-Based Training (WBT), Other: Work Sample Review (WR), Other: Step up to session audio reviewWeb-Based Training (WBT) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review. |
| Condition 1-D | Experimental | Other: Web-Based Training (WBT), Other: Work Sample Review (WR), Other: Continue in Standard ConsultationWeb-Based Training (WBT) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation. |
| Condition 2-A | Experimental | Other: Web-Based Training (WBT), Other: Step down to fidelity self-monitoring, Other: Standard Consultation (SC)Web-Based Training (WBT) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring. |
| Condition 2-B | Experimental | Other: Web-Based Training (WBT), Other: Standard Consultation (SC)Web-Based Training (WBT) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation. |
| Condition 2-C | Experimental | Other: Web-Based Training (WBT), Other: Step up to session audio review, Other: Standard Consultation (SC)Web-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + step up to session audio review. |
| Condition 2-D | Experimental | Other: Web-Based Training (WBT), Other: Standard Consultation (SC), Other: Continue in Standard ConsultationWeb-Based Training (WBT) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation. |
| Condition 3-A | Experimental | Other: Work Sample Review (WR), Other: Step down to fidelity self-monitoring, Other: Standard Training (ST)Standard Training (ST) + Work-Sample Review (WR) + early fidelity + step down to fidelity self-monitoring. |
| Condition 3-B | Experimental | Other: Work Sample Review (WR), Other: Standard Training (ST)Standard Training (ST) + Work-Sample Review (WR) + early fidelity + continue in Standard Consultation. |
| Condition 3-C | Experimental | Other: Work Sample Review (WR), Other: Step up to session audio review, Other: Standard Training (ST)Standard Training (ST) + Work-Sample Review (WR) + fidelity in progress + step up to session audio review. |
| Condition 3-D | Experimental | Other: Work Sample Review (WR), Other: Standard Training (ST), Other: Continue in Standard ConsultationStandard Training (ST) + Work-Sample Review (WR)+ fidelity in progress + continue in Standard Consultation. |
| Condition 4-A | Experimental | Other: Step down to fidelity self-monitoring, Other: Standard Consultation (SC), Other: Standard Training (ST)Standard Training (ST) + Standard Consultation (SC) + early fidelity + step down to fidelity self-monitoring. |
| Condition 4-B | Experimental | Other: Standard Consultation (SC), Other: Standard Training (ST), Other: Continue in Standard ConsultationStandard Training (ST) + Standard Consultation (SC) + early fidelity + continue in Standard Consultation. |
| Condition 4-C | Experimental | Other: Step up to session audio review, Other: Standard Consultation (SC), Other: Standard Training (ST)Standard Training (ST) + Standard Consultation (SC) + fidelity in progress + step up to session audio review. |
| Condition 4-D | Experimental | Other: Standard Consultation (SC), Other: Standard Training (ST), Other: Continue in Standard ConsultationStandard Training (ST) + Standard Consultation (SC) + fidelity in progress + continue in Standard Consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Participant is not a licensed mental health clinician
- Participant is already certified in CPT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Training (WBT)A self-paced online training course that includes video demonstrations, self-guided modules, and clinical materials/resources. | Other | 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)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. | Other | 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-monitoringAfter 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. | Other | Condition 1-A, Condition 2-A, Condition 3-A, Condition 4-A |
| Step up to session audio reviewAfter 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. | Other | Condition 1-C, Condition 2-C, Condition 3-C, Condition 4-C |
| Standard Consultation (SC)Four months of weekly hour-long group consultation | Other | 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)2-day instructor-led CPT workshop. | Other | 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 ConsultationAfter four months, therapists will continue to attend weekly hour-long group consultation for another two months. | Other | Condition 1-D, Condition 2-D, Condition 3-D, Condition 4-B, Condition 4-D |
Primary outcome
CPT Therapist Adherence and Competence Scale (TAC)
Time frame: Baseline (0-months), 6-months, 9-months, and 12-months
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.
1 secondary outcome
The Cognitive Therapy Scale-Revised (CTS-R)
Time frame: Baseline (0-months), 6-months, 9-months, and 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Stress Disorders, Post-Traumatic
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabel Gracy, BS contact
Rebecca Kaufman Sripada, PhD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Training (WBT), Work Sample Review (WR) and Step down to fidelity self-monitoring in people with Stress Disorders, Post-Traumatic and Psychotherapy, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca K Sripada, PhD MS ((734) 222-7432, rebecca.sripada@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPT Therapist Adherence and Competence Scale (TAC) (time frame: Baseline (0-months), 6-months, 9-months, and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.