Post Traumatic Stress DisorderNCT02449421
Sustaining and Improving Clinicians' Use of Evidence-Based Psychotherapy (EBP) for PTSD
A study testing Quality Improvement Learning Community and Fidelity-oriented Learning Community in people with Post Traumatic Stress Disorder, run by Toronto Metropolitan University at 3 sites in 2 countries.
Trial summary
The purpose of the study is to compare the impact of two strategies to sustain and improve the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT) in three different mental health systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Quality Improvement Learning Community and Fidelity-oriented Learning Community
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 May 2015to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All clinicians that provide psychotherapy to patients with PTSD
- Agree to provide CPT to 6 patients over 2 years
- Consent to be randomized to one of two study conditions
- Are willing to record therapy sessions
- Continue to have computer/internet access.
- Patients will be clients of clinician participants that
Show all 9Show fewer
- Are 18 years or older
- Have a diagnosis of PTSD
- Are willing to have their sessions audiorecorded
Who cannot join
- Ineligible patient participants are those having
- Current uncontrolled psychotic or bipolar disorder
- Unremitted substance dependence
- Current imminent suicidality or homicidality that requires imminent attention
- Significant cognitive impairment
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
VA Palo Alto Healthcare System
Menlo Park, California, 94024
UTHSCSA
San Antonio, California, 78229
About this study
Official title: A Comparison of the Effects of Internet-Based Strategies to Support Mental Health Clinicians' Use of an Effective Psychotherapy for Post Traumatic Stress Disorder (PTSD) in Mental Health Systems
The purpose of the study is to compare the impact of two strategies to sustain and improve the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT) in three different mental health systems. These approaches are based on two different theories of what is necessary to promote successful implementation. We will examine whether these strategies lead to improved patient outcomes, clinician skill, proportion of clients who receive CPT, and other outcomes that are relevant to the implementation of evidence-based psychosocial treatments. By examining these questions in 3 different mental health systems, we will also examine whether the implementation strategies yield different results in different systems.
Read the detailed description
This project will compare two different methods of post-training support to promote sustained and improved CPT delivery: Fidelity-oriented learning community (FID-LC) and Continuous Quality Improvement Learning Community (CQI-LC). Clinics in which clinicians have previously received CPT training will be randomly assigned to one of these conditions. Outcomes will be observed changes in patient symptoms during and following treatment, independent expert assessment of clinician fidelity and adaptations in delivering the psychotherapy (via audio-recordings), proportion of eligible caseloads that receive CPT, and capacity to deliver CPT. Data will also be collected to assess clinician and setting characteristics that may contribute to the success of each strategy. The study results will help inform how best to support the ongoing implementation and benefits of evidence-based psychotherapy (e.g., CPT) in routine clinical settings. This is a knowledge translation project in partnership with 3 systems; VA Canada, U.S. Veterans Health Care System and the National Centre for PTSD.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Quality Improvement Learning Community, Fidelity-oriented Learning Community
- Keywords
- trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement Learning CommunityBehavioural
Consultation with CPT experts to effectively use evidence-based psychotherapy.
Fidelity-oriented Learning CommunityBehavioural
The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.
| Study group | Role | What they receive |
|---|---|---|
| Fidelity-oriented Learning Community | Experimental | The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings. Receives: Behavioral: Fidelity-oriented Learning Community |
| Quality Improvement Learning Community | Experimental | The Quality Improvement Learning Community arm will include clinicians who set goals related to CPT delivery, execute a plan, study results, refine plan, and continue each cycle until goals are met. Receives: Behavioral: Quality Improvement Learning Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptoms over 6 months (PCL-5 measure)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is measured on a 5-point Likert scale. The PCL will track change from baseline to the 3 month follow up.
Measured: Participants will be followed for an expected duration of 12 weeks of therapy. PCL-5 will be measured at baseline, at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, post-treatment week, and at 3-month follow-up.
Secondary outcomes (3)
Fidelity Measure
The fidelity measure examines clinicians' adherence and competence to specific CPT interventions prescribed in each session. Clinicians are rated on their adherence to the protocol (on a 0-2 Likert-type scale), as well as their competence in delivery of these elements (rated on a 7-point, Likert-type scale).
Measured: At baseline, at 12 and 24 months
Content-Level and Context-Level Adaptation
Using a framework and coding system of modifications and adaptations made to EBPs, sessions will be rated to identify 11 potential content-level adaptations, as well as 5 context-level modifications.
Measured: At baseline, at 12 and 24 months
CPT Activity Reporting
All clinicians will report monthly on CPT activity: caseload size, frequency, duration and satisfaction with the LC over the past month, number of new CPT patients, clinician confidence rating in their CPT delivery.
Measured: monthly for up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study start6 May 2015
- Primary completionDec 2022
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Canadian Institutes of Health Research (CIHR), National Institute of Mental Health (NIMH), Palo Alto Veterans Institute for Research, National Center for PTSD
- Responsible party
- Principal investigator, Candice Monson, Toronto Metropolitan University
- Investigators
- Candice Monson, PhD, Principal investigator, Toronto Metropolitan UniversityShannon Wiltsey Stirman, PhD, Principal investigator, National Center for PTSDNorman Shields, PhD, Principal investigator, Royal Canadian Mounted Police
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449421
- Sponsor's protocol ID
- REB: 2014-345
- Other IDs
- 137012, R01MH106506-01
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2015
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share IPD.
Publications
Thomas FC, Loskot T, Mutschler C, Burdo J, Lagdamen J, Sijercic I, Lane JEM, Liebman RE, Finley EP, Monson CM, Wiltsey-Stirman S. Initiating Cognitive Processing Therapy (CPT) in Community Settings: A Qualitative Investigation of Therapist Decision-Making. Adm Policy Ment Health. 2023 Jan;50(1):137-150. doi: 10.1007/s10488-022-01229-8. Epub 2022 Nov 12.
PubMed 36370226Wiltsey Stirman S, Finley EP, Shields N, Cook J, Haine-Schlagel R, Burgess JF Jr, Dimeff L, Koerner K, Suvak M, Gutner CA, Gagnon D, Masina T, Beristianos M, Mallard K, Ramirez V, Monson C. Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial. Implement Sci. 2017 Mar 6;12(1):32. doi: 10.1186/s13012-017-0544-5.
PubMed 28264720
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Internet-Based Strategies to Support Mental Health Clinicians' Use of an Effective Psychotherapy for Post Traumatic Stress Disorder (PTSD) in Mental Health Systems
- ClinicalTrials.gov ID
- NCT02449421
- Acronym / sponsor ID
- REB: 2014-345
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Stanford University, Canadian Institutes of Health Research (CIHR), National Institute of Mental Health (NIMH), Palo Alto Veterans Institute for Research, National Center for PTSD
- Study start
- 6 May 2015 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 20 May 2015 (estimated)
- 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.
The purpose of the study is to compare the impact of two strategies to sustain and improve the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT) in three different mental health systems. These approaches are based on two different theories of what is necessary to promote successful implementation. We will examine whether these strategies lead to improved patient outcomes, clinician skill, proportion of clients who receive CPT, and other outcomes that are relevant to the implementation of evidence-based psychosocial treatments. By examining these questions in 3 different mental health systems, we will also examine whether the implementation strategies yield different results in different systems.
Detailed description
This project will compare two different methods of post-training support to promote sustained and improved CPT delivery: Fidelity-oriented learning community (FID-LC) and Continuous Quality Improvement Learning Community (CQI-LC). Clinics in which clinicians have previously received CPT training will be randomly assigned to one of these conditions. Outcomes will be observed changes in patient symptoms during and following treatment, independent expert assessment of clinician fidelity and adaptations in delivering the psychotherapy (via audio-recordings), proportion of eligible caseloads that receive CPT, and capacity to deliver CPT. Data will also be collected to assess clinician and setting characteristics that may contribute to the success of each strategy. The study results will help inform how best to support the ongoing implementation and benefits of evidence-based psychotherapy (e.g., CPT) in routine clinical settings. This is a knowledge translation project in partnership with 3 systems; VA Canada, U.S. Veterans Health Care System and the National Centre for PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fidelity-oriented Learning Community | Experimental | Behavioral: Fidelity-oriented Learning CommunityThe Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings. |
| Quality Improvement Learning Community | Experimental | Behavioral: Quality Improvement Learning CommunityThe Quality Improvement Learning Community arm will include clinicians who set goals related to CPT delivery, execute a plan, study results, refine plan, and continue each cycle until goals are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All clinicians that provide psychotherapy to patients with PTSD
- Agree to provide CPT to 6 patients over 2 years
- Consent to be randomized to one of two study conditions
- Are willing to record therapy sessions
- Continue to have computer/internet access.
Key exclusion criteria (5 listed)
- Ineligible patient participants are those having
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 |
|---|---|---|
| Quality Improvement Learning CommunityConsultation with CPT experts to effectively use evidence-based psychotherapy. | Behavioural | Quality Improvement Learning Community |
| Fidelity-oriented Learning CommunityThe Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings. | Behavioural | Fidelity-oriented Learning Community |
Primary outcome
Change in PTSD Symptoms over 6 months (PCL-5 measure)
Time frame: Participants will be followed for an expected duration of 12 weeks of therapy. PCL-5 will be measured at baseline, at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, post-treatment week, and at 3-month follow-up.
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is measured on a 5-point Likert scale. The PCL will track change from baseline to the 3 month follow up.
3 secondary outcomes
Fidelity Measure
Time frame: At baseline, at 12 and 24 months
Content-Level and Context-Level Adaptation
Time frame: At baseline, at 12 and 24 months
CPT Activity Reporting
Time frame: monthly for up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 36370226Thomas FC, Loskot T, Mutschler C, Burdo J, Lagdamen J, Sijercic I, Lane JEM, Liebman RE, Finley EP, Monson CM, Wiltsey-Stirman S. Initiating Cognitive Processing Therapy (CPT) in Community Settings: A Qualitative Investigation of Therapist Decision-Making. Adm Policy Ment Health. 2023 Jan;50(1):137-150. doi: 10.1007/s10488-022-01229-8. Epub 2022 Nov 12.
- Derived from this study: PubMed 28264720Wiltsey Stirman S, Finley EP, Shields N, Cook J, Haine-Schlagel R, Burgess JF Jr, Dimeff L, Koerner K, Suvak M, Gutner CA, Gagnon D, Masina T, Beristianos M, Mallard K, Ramirez V, Monson C. Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial. Implement Sci. 2017 Mar 6;12(1):32. doi: 10.1186/s13012-017-0544-5.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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. This study is not recruiting at the moment.
Candice Monson, PhD principal investigator
Toronto Metropolitan University
Shannon Wiltsey Stirman, PhD principal investigator
National Center for PTSD
Norman Shields, PhD principal investigator
Royal Canadian Mounted Police
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Learning Community and Fidelity-oriented Learning Community in people with Post Traumatic Stress Disorder, run by Toronto Metropolitan University at 3 sites in 2 countries.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptoms over 6 months (PCL-5 measure) (time frame: Participants will be followed for an expected duration of 12 weeks of therapy. PCL-5 will be measured at baseline, at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, post-treatment week, and at 3-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449421, which also lists 2 linked publications.
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 17 Jan 2024.