- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06432374
Written Exposure Therapy for Nurses
Open Pilot of Written Exposure Therapy for Nurses Experiencing Work-Related Posttraumatic Stress
Nurses often experience elevated levels of stress, overwork, and trauma in the workplace, leading to posttraumatic stress disorder (PTSD), depression, burnout, and even nurse turnover. While effective therapies for PTSD exist, barriers to treatment arise from nursing culture, such as workplace stigma about mental health problems, fear that psychological status may impact performance evaluations, and demands of shiftwork. There is a pressing need for scalable evidence-based interventions tailored to nursing culture to effectively address PTSD and related mental health issues. The study aimed to assess the feasibility, safety, and acceptability of a tailored evidence-based treatment, Written Exposure Therapy (WET), for nurses experiencing work-related traumatic stress.
This single-arm open pilot study with pre- and post-intervention assessments, included participants from two nursing schools' alumni. Eligibility criteria included nurses screening positive for work-related trauma with a report of at least two PTSD symptoms. Participants engaged in a self-administered, asynchronous, five-week online writing session, facilitated by WET-trained nurses. Outcomes measures (PTSD, depression, anxiety, burnout, and intention to quit) were assessed at baseline, post-intervention, and 5-weeks follow-up.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48104
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Work-related trauma
- Posttraumatic stress disorder
Exclusion Criteria:
- Current substance abuse
- Current suicidality
- Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Written Exposure Therapy
WET is a trauma-focused therapy for PTSD.
It includes five writing sessions.
|
The five weekly WET sessions were delivered online via Canvas.
Five session modules were created, each containing writing instructions for the respective session and an assignment feature for participants to upload their narratives.
All sessions included 30 minutes of writing.
Following instructions, participants wrote about a specific work-related trauma event in detail and described the emotions and thoughts experienced during the event.
While all sessions were self-paced, participants were advised to complete each subsequent session within one week.
Participants had the option to self-administer sessions or participate in Zoom "office hours" for live writing sessions with a facilitator who had completed WET training providing the writing instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posttraumatic stress disorder
Time Frame: Baseline, immediately post-intervention, and 5 weeks follow-up
|
The PTSD Checklist for DSM-5 was used to assess symptoms of posttraumatic stress disorder in the past month.
The total score ranges from 0-80, with higher scores indicating more severe PTSD symptoms.
|
Baseline, immediately post-intervention, and 5 weeks follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Baseline, immediately post-intervention, and 5 weeks follow-up
|
The Patient Health Questionnaire-8 was used to assess the frequency of depressed mood in the past two weeks.
The total score ranges from 0-24, with higher scores indicating more severe depression symptoms.
|
Baseline, immediately post-intervention, and 5 weeks follow-up
|
|
Anxiety
Time Frame: Baseline, immediately post-intervention, and 5 weeks follow-up
|
The Generalized Anxiety Disorder-7 was used to assess the frequency of anxiety symptoms in the past two weeks.
The total score ranges from 0-21, with higher scores indicating more severe anxiety symptoms.
|
Baseline, immediately post-intervention, and 5 weeks follow-up
|
|
Professional Quality of Life
Time Frame: Baseline, immediately post-intervention, and 5 weeks follow-up
|
The Professional Quality of Life was used to assess compassion satisfaction, burnout, and secondary traumatic stress.
Each subscale score ranges from 10-50, with higher scores indicating higher levels of compassion satisfaction, more burnout symptoms, and more secondary traumatic stress.
|
Baseline, immediately post-intervention, and 5 weeks follow-up
|
|
Intention to Quit
Time Frame: Baseline, immediately post-intervention, and 5 weeks follow-up
|
Intention to quit the job or leave the nursing profession were asked using two questions - "How often have you thought about quitting your job in the past month?",
"How often have you thought about leaving the nursing profession in the past month?".
The five responses are "never," "rarely," "sometimes," "very often", and "always."
The scores for both intention to quit the job and intention to leave the nursing profession range from 1-5, with higher scores indicating greater intention to quit the job or leave the nursing profession.
|
Baseline, immediately post-intervention, and 5 weeks follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00203166
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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