PTSDPE-PC PilotNCT03711266
Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
A study testing PE-PC in people with PTSD, run by University of Michigan at 2 sites in United States.
Trial summary
The purpose of this project is to expand access to trauma-focused treatment among Medicaid Enrollees with PTSD, thereby improving the quality of mental health services delivered to this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- PE-PC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- receive care at a Michigan CHC
- have a PCL-5 score ≥33
- have had psychotropic medication stability for at least 4 weeks
Who cannot join
- substantially cognitively impaired (according to the Mini-Cog)
- unable to agree to study procedures for any reason (including incompetency)
- at high risk of suicide
- currently engaged in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy)
- unable to speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baldwin Family Health Care-Cadillac Clinic
Cadillac, Michigan, 49349
Hamilton Community Health Network-Flint Clinic
Flint, Michigan, 48503
About this study
Official title: Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
The purpose of this project is to expand access to trauma-focused treatment among Medicaid Enrollees with PTSD, thereby improving the quality of mental health services delivered to this population. Specifically, the project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan.
Read the detailed description
This project directly addresses the Michigan Department of Health and Human Services (MDHHS) Mental Health and Wellness commission priority to provide "better access to high quality, coordinated and consistent service and care between agencies, service providers and across geographical boundaries."
The project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan. CHCs serve 680,000 Michigan residents across 260 delivery sites. Ninety-two percent of CHC patients have incomes below 200 percent of the federal poverty level. Approximately 16 percent of CHC patients are uninsured, and more than 53 percent rely on Medicaid for their insurance. Thus, providing PTSD treatment to CHC patients will improve care to Medicaid enrollees and promote Mental Health and Wellness commission priorities of developing a trauma informed system that includes implementation of evidence-based trauma-informed care.
To address the high burden of PTSD in Medicaid enrollees in Michigan CHCs, we plan to deliver PE-PC to patients in CHCs. This treatment consists of four 30-minute sessions of in-vivo and narrative exposure, with content drawn from the PE model. Recently published efficacy data from a randomized controlled trial showed that PE-PC significantly reduced PTSD and depression symptoms as compared to usual primary care treatment. These changes were maintained at 6-month follow-up.
- Conditions
- PTSD
- Being tested
- PE-PC
- 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.
PE-PCBehavioural
PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| PE-PC | Experimental | Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. Receives: Behavioral: PE-PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptoms (as Measured by the PCL-5)
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores ≥ 33 indicate a probable diagnosis of PTSD. Data presented represent a change from baseline PCL-5 assessment to the 4-month PCL-5 assessment (e.g., value at baseline minus value at 4 months).
Measured: Baseline, 4-months
Secondary outcomes (3)
Change in Depressive Symptoms (as Measured by the PHQ-9)
The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day) with a range of scores between 0-27. Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Data presented represent a change from baseline PHQ-9 assessment to the 4-month PHQ-9 assessment (e.g., value at baseline minus value at 4 months).
Measured: Baseline, 4-months
Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)
Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. All items on the RAS assessment are rated on a 5-point Likert scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Not Sure, 4 = Agree, and 5 = Strongly Agree with a range of scores between 20-100. All items are summed to compute a total score. Higher scores indicate greater recovery orientation. The RAS-SF shows evidence for both convergent and discriminant validity when compared to quality of life, social support, and symptomatic scales. Data presented represent a change from baseline RAS-SF assessment to the 4-month RAS-SF assessment (e.g., value at baseline minus value at 4 months)).
Measured: Baseline, 4-months
Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)
The PTCI is a 33-item scale of trauma-related thoughts and beliefs which is rated on a Likert-type scale ranging from 1 (totally disagree) to 7 (totally agree). It is composed of 3 subscales. Each subscale is calculated by averaging the items in the subscale. The PTCI total score is calculated as the sum of the three subscales and ranges from 3 to 21. Results reported here are total scores, not subscale scores. Higher scores represent more dysfunctional cognitions. Data presented represent a change from baseline PTCI assessment to the 4-month PTCI assessment (e.g., value at baseline minus value at 4 months).
Measured: Baseline, 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Rebecca Sripada, University of Michigan
- Investigators
- Rebecca Sripada, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711266
- Sponsor's protocol ID
- HUM00149877
- Acronym
- PE-PC Pilot
- Status last verified
- Dec 2021
- First submitted
- 12 Oct 2018
- Last updated
- 18 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sripada RK, Walters HM, Ganoczy D, Avallone KM, Cigrang JA, Rauch SAM. Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. Adm Policy Ment Health. 2022 Sep;49(5):722-734. doi: 10.1007/s10488-022-01195-1. Epub 2022 Apr 20.
PubMed 35445362
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
- ClinicalTrials.gov ID
- NCT03711266
- Acronym / sponsor ID
- PE-PC Pilot / HUM00149877
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 18 Feb 2022
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 this project is to expand access to trauma-focused treatment among Medicaid Enrollees with PTSD, thereby improving the quality of mental health services delivered to this population. Specifically, the project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan.
Detailed description
This project directly addresses the Michigan Department of Health and Human Services (MDHHS) Mental Health and Wellness commission priority to provide "better access to high quality, coordinated and consistent service and care between agencies, service providers and across geographical boundaries."
The project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan. CHCs serve 680,000 Michigan residents across 260 delivery sites. Ninety-two percent of CHC patients have incomes below 200 percent of the federal poverty level. Approximately 16 percent of CHC patients are uninsured, and more than 53 percent rely on Medicaid for their insurance. Thus, providing PTSD treatment to CHC patients will improve care to Medicaid enrollees and promote Mental Health and Wellness commission priorities of developing a trauma informed system that includes implementation of evidence-based trauma-informed care.
To address the high burden of PTSD in Medicaid enrollees in Michigan CHCs, we plan to deliver PE-PC to patients in CHCs. This treatment consists of four 30-minute sessions of in-vivo and narrative exposure, with content drawn from the PE model. Recently published efficacy data from a randomized controlled trial showed that PE-PC significantly reduced PTSD and depression symptoms as compared to usual primary care treatment. These changes were maintained at 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PE-PC | Experimental | Behavioral: PE-PCEligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- receive care at a Michigan CHC
- have a PCL-5 score ≥33
- have had psychotropic medication stability for at least 4 weeks
Key exclusion criteria (5 listed)
- substantially cognitively impaired (according to the Mini-Cog)
- unable to agree to study procedures for any reason (including incompetency)
- at high risk of suicide
- currently engaged in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy)
- unable to speak English
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 |
|---|---|---|
| PE-PCPE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks | Behavioural | PE-PC |
Primary outcome
Change in PTSD Symptoms (as Measured by the PCL-5)
Time frame: Baseline, 4-months
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores ≥ 33 indicate a probable diagnosis of PTSD. Data presented represent a change from baseline PCL-5 assessment to the 4-month PCL-5 assessment (e.g., value at baseline minus value at 4 months).
3 secondary outcomes
Change in Depressive Symptoms (as Measured by the PHQ-9)
Time frame: Baseline, 4-months
Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)
Time frame: Baseline, 4-months
Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)
Time frame: Baseline, 4-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35445362Sripada RK, Walters HM, Ganoczy D, Avallone KM, Cigrang JA, Rauch SAM. Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. Adm Policy Ment Health. 2022 Sep;49(5):722-734. doi: 10.1007/s10488-022-01195-1. Epub 2022 Apr 20.
- Individual participant dataSharing planned: No
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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.
Rebecca Sripada, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PE-PC in people with PTSD, run by University of Michigan at 2 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 3 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: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (as Measured by the PCL-5) (time frame: Baseline, 4-months). 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 NCT03711266, which also lists 1 linked publication.
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 18 Feb 2022.