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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: Prolonged Exposure for Primary CareExperimental treatment 1 intervention
Group B: EAP Treatment as Usual (TAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline to 6 months

Secondary outcomes

1

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.

Time frame
baseline to 6 months
2

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).

Time frame
baseline to 6 months
3

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.

Time frame
baseline to 6 months
4

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.

Time frame
baseline to 6 months

Other outcomes

Sponsors and contacts

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University of Michigan

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator