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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06432374
Other study ID # HUM00203166
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 1, 2022
Est. completion date September 1, 2023

Study information

Verified date May 2024
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
WET
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Posttraumatic stress disorder 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 Depression 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
Secondary Anxiety 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
Secondary Professional Quality of Life 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
Secondary Intention to Quit 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
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