Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers

Post Traumatic Stress Disorder Clinical Trial

Official title:

Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751473
• Other study ID #: HUM00219260
• Secondary ID: 1R01MH126693-01
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: James Garlick
• Phone: 734-232-2663
• Email: jgarlick[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are employees at an orginization served by a participating EAP
• Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score =33
• Have had psychotropic medication stability for at least 4 weeks

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:

• Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
• High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)
• Need for detoxification
• Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment
• Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
• Patients who do not speak English will be excluded for logistical reasons.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure for Primary Care (PE-PC)
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.
• EAP Treatment as Usual (TAU)
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Tanner Health System	Carrollton	Georgia
United States	University of Cincinati Health	Cincinnati	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Michigan State University	East Lansing	Michigan
United States	ProMedica	Fremont	Ohio
United States	Cope NewYork-Presbyterian	New York	New York
United States	Sharp Healthcare	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)	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
Secondary	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
Secondary	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