NCT06432374

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 21, 2024

Last Update Submit

May 28, 2024

Conditions

Keywords

NursesWritten Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Depression

    Baseline, immediately post-intervention, and 5 weeks follow-up

  • Anxiety

    Baseline, immediately post-intervention, and 5 weeks follow-up

  • Professional Quality of Life

    Baseline, immediately post-intervention, and 5 weeks follow-up

  • Intention to Quit

    Baseline, immediately post-intervention, and 5 weeks follow-up

Study Arms (1)

Written Exposure Therapy

EXPERIMENTAL

WET is a trauma-focused therapy for PTSD. It includes five writing sessions.

Behavioral: WET

Interventions

WETBEHAVIORAL

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.

Written Exposure Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Work-related trauma
  • Posttraumatic stress disorder

You may not qualify if:

  • Current substance abuse
  • Current suicidality
  • Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionBurnout, PsychologicalAnxiety DisordersOccupational Stress

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorStress, PsychologicalOccupational Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 29, 2024

Study Start

February 1, 2022

Primary Completion

March 1, 2023

Study Completion

September 1, 2023

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations