Posttraumatic Stress DisorderEarly Phase 1NCT06432374
Written Exposure Therapy for Nurses
A Early Phase 1 study testing WET in people with Posttraumatic Stress Disorder and Depressive Symptoms, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Depressive Symptoms, Burn Out
- What is being tested?
- WET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Work-related trauma
- Posttraumatic stress disorder
Who cannot join
- Current substance abuse
- Current suicidality
- Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Posttraumatic Stress Disorder, Depressive Symptoms, Burn Out, Anxiety, Work Related Stress
- Being tested
- WET
- Keywords
- Nurses, Written Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Burnout, Psychological, Anxiety Disorders, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WETBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Experimental | WET is a trauma-focused therapy for PTSD. It includes five writing sessions. Receives: Behavioral: WET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-intervention, and 5 weeks follow-up
Secondary outcomes (4)
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.
Measured: Baseline, immediately post-intervention, and 5 weeks follow-up
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.
Measured: Baseline, immediately post-intervention, and 5 weeks follow-up
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.
Measured: Baseline, immediately post-intervention, and 5 weeks follow-up
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.
Measured: Baseline, immediately post-intervention, and 5 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Feb 2022
- Primary completion1 Mar 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Yang Li, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432374
- Sponsor's protocol ID
- HUM00203166
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Pilot of Written Exposure Therapy for Nurses Experiencing Work-Related Posttraumatic Stress
- ClinicalTrials.gov ID
- NCT06432374
- Acronym / sponsor ID
- HUM00203166
- Conditions
- Posttraumatic Stress Disorder, Depressive Symptoms, Burn Out, Anxiety, Work Related Stress
- Keywords
- Nurses, Written Exposure Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral: WETWET is a trauma-focused therapy for PTSD. It includes five writing sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Work-related trauma
- Posttraumatic stress disorder
Key exclusion criteria (3 listed)
- Current substance abuse
- Current suicidality
- Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WETThe 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. | Behavioural | Written Exposure Therapy |
Primary outcome
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.
4 secondary outcomes
Depression
Time frame: Baseline, immediately post-intervention, and 5 weeks follow-up
Anxiety
Time frame: Baseline, immediately post-intervention, and 5 weeks follow-up
Professional Quality of Life
Time frame: Baseline, immediately post-intervention, and 5 weeks follow-up
Intention to Quit
Time frame: Baseline, immediately post-intervention, and 5 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WET in people with Posttraumatic Stress Disorder and Depressive Symptoms, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic stress disorder (time frame: Baseline, immediately post-intervention, and 5 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.