Back to resultsReducing Posttraumatic Stress Disorder (PTSD) Symptoms in Frontline Health Care Workers
Primary Purpose
Post Traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure for Primary Care (PE-PC)
EAP Treatment as Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Employee Assistance Programs, Frontline Healthcare Workers, Prolonged Exposure for Primary Care
Eligibility Criteria
Inclusion Criteria: Are employees at a healthcare system 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.
Sites / Locations
- Sharp Healthcare
- University of MichiganRecruiting
- Henry Ford Health System
- Michigan State University
- Cope NewYork-Presbyterian
- University of Cincinati Health
- ProMedicaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prolonged Exposure for Primary Care
EAP Treatment as Usual (TAU)
Arm Description
Employee Assistance Programs standard treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
NCT ID
NCT05751473
First Posted
February 20, 2023
Last Updated
May 18, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05751473
Brief Title
Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in Frontline Health Care Workers
Official Title
Reducing PTSD Symptoms in Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is being completed to address PTSD symptoms in Health System workers after the COVID-19 pandemic. Specifically, the study team is testing whether an adapted PTSD treatment (talk therapy) effectively treats PTSD when provided in Employee Assistance Programs (EAPs).
The central hypothesis is that Prolonged Exposure for Primary Care (PE-PC) will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Employee Assistance Programs, Frontline Healthcare Workers, Prolonged Exposure for Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prolonged Exposure for Primary Care
Arm Type
Experimental
Arm Title
EAP Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Employee Assistance Programs standard treatment.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure for Primary Care (PE-PC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EAP Treatment as Usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
Description
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 Outcome Measure Information:
Title
Change in Burnout based on the Oldenburg Burnout Inventory
Description
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
Title
Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)
Description
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
Title
Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)
Description
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
Title
Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are employees at a healthcare system 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Garlick
Phone
734-845-5712
Email
jgarlick@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Hemphill
Email
hnaomi@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Sripada, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92129
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Levy, LCSW, CEAP
Phone
619-681-0024
Email
michael.levy@sharp.com
First Name & Middle Initial & Last Name & Degree
Michael Levy, LCSW, CEAP
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Garlick
Email
jgarlick@umich.edu
First Name & Middle Initial & Last Name & Degree
Naomi Hemphill
Email
hnaomi@umich.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Sripada, PhD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Szalka, LMSW,CEAP
Phone
313-874-7122
Email
bszalka1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Brenda Szalka, LMSW,CEAP
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824-1037
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Novello, LMSW,ACSW
Phone
517-355-4509
Email
novelloj@msu.edu
First Name & Middle Initial & Last Name & Degree
Jon Novello, LMSW,ACSW
Facility Name
Cope NewYork-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy Martin, PhD
Phone
646-988-1763
Email
rdm4002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Randy Martin, PhD
Facility Name
University of Cincinati Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Melink, MA,LPCC
Phone
513-585-6094
Email
lisa.melink@uchealth.com
First Name & Middle Initial & Last Name & Degree
Lisa Melink, MA,LPCC
Facility Name
ProMedica
City
Fremont
State/Province
Ohio
ZIP/Postal Code
43420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Tafelski, LPCC,CEAP
Phone
419-291-1219
Ext
211219
Email
Christopher.tafelski@promedica.org
First Name & Middle Initial & Last Name & Degree
Chris Tafelski, LPCC,CEAP
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in Frontline Health Care Workers
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