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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH126693-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).
The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure for Primary Care | Experimental |
| |
| EAP Treatment as Usual (TAU) | Active Comparator | Employee Assistance Programs standard treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Behavioral | Treatment will be given by telehealth or in person, depending on the participant preference. Content is drawn from the Full Prolonged Exposure model and condensed so as to deliver the most efficacious components in a brief format. There will be 4-6 weekly 30-minute sessions. Treatment follows the standardized PE-PC manual and workbook. At the end of the final session, the counselor and participant will review treatment progress and either conclude treatment or refer the participant to outside mental healthcare for more intensive treatment. Participants will complete surveys and complete homework during and following the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score | The PCL-5 is a 20-item self-report measure that assesses symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The minimum and maximum values are 0 and 80, with higher scores indicating worse outcome. | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Burnout based on the Oldenburg Burnout Inventory | This is a 16-question inventory that assesses burnout. The self-report rating scale is 1-4 for each symptom.The minimum and maximum values are 16 and 64, with higher scores indicating worse outcome. | baseline to 6 months |
| Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH) |
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Inclusion Criteria:
Inclusion criteria for the qualitative portion of the study:
- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Garlick | Contact | 734-232-2663 | jgarlick@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Sripada, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Healthcare | Withdrawn | San Diego | California | 92129 | United States | |
| Tanner Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41352531 | Derived | Sripada RK, Garlick J, Hemphill N, Walters HM, Ganoczy D, Kim HM, Zivin K, Nevedal AL, Avallone KM, Cigrang JA, Rauch SAM. Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108174. doi: 10.1016/j.cct.2025.108174. Epub 2025 Dec 4. |
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| EAP Treatment as Usual (TAU) | Behavioral | Treatment will be given by telehealth or in person, depending on the participant preference and current EAP practices (4-6 weeks). This will be the standard of care practice at each EAP site. Usually, this includes up to six sessions of solution focused therapy, and referrals to an established network of community providers who specialize in PTSD treatment. All PTSD care received during the study will be collected and monitored as TAU. The type of TAU used will reflect the current practice in EAPs and will not be constrained in the study design. EAP staff will monitor and record all EAP care received, including tracking no shows and cancellations. Study team members will document care received outside of the EAP (including psychiatric medications) by self-report. Participants will complete surveys and complete homework during and following the study. |
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The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 visual analog scale (VAS). |
| baseline to 6 months |
| Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9) | This is a 9-item questionnaire that participants select responses from not at all (0) to nearly every day (3), the minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome. | baseline to 6 months |
| Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8) | This is an 8-item questionnaire that participants complete. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. | baseline to 6 months |
| Recruiting |
| Carrollton |
| Georgia |
| 30117 |
| United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Henry Ford Health System | Active, not recruiting | Detroit | Michigan | 48202 | United States |
| Detroit Fire Department | Recruiting | Detroit | Michigan | 48226 | United States |
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| Health Management Systems of America | Recruiting | Detroit | Michigan | 48226 | United States |
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| Michigan State University | Recruiting | East Lansing | Michigan | 48824-1037 | United States |
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| West Bloomfield Fire Department | Active, not recruiting | West Bloomfield | Michigan | 48322 | United States |
| Rutgers Health | Recruiting | Piscataway | New Jersey | 08854 | United States |
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| Cope NewYork-Presbyterian | Recruiting | New York | New York | 10017 | United States |
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| Duke University Health System | Recruiting | Durham | North Carolina | 27705 | United States |
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| University of Cincinati Health | Not yet recruiting | Cincinnati | Ohio | 45229 | United States |
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| ProMedica | Recruiting | Fremont | Ohio | 43420 | United States |
|
| Houston Fire Department | Recruiting | Houston | Texas | 77002 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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