## Protocol Section
### Identification Module
**NCT ID:** NCT06432374

**Brief Title:** Written Exposure Therapy for Nurses

**Official Title:** Open Pilot of Written Exposure Therapy for Nurses Experiencing Work-Related Posttraumatic Stress

#### Organization Study ID Info
**ID:** HUM00203166
#### Organization
**Class:** OTHER
**Full Name:** University of Texas at Austin
### Status Module
#### Completion Date
**Date:** 2023-09-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Michigan

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Texas at Austin

#### Responsible Party

**Investigator Affiliation:** University of Texas at Austin

**Investigator Full Name:** Yang Li

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Posttraumatic Stress Disorder

- Depressive Symptoms

- Burn Out

- Anxiety

- Work Related Stress

**Keywords:**

- Nurses

- Written Exposure Therapy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: WET

**Label:** Written Exposure Therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Written Exposure Therapy

**Description:** 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.

**Name:** WET

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Posttraumatic stress disorder

**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up

#### Secondary Outcomes

**Description:** 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.

**Measure:** Depression

**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up

**Description:** 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.

**Measure:** Anxiety

**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up

**Description:** 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.

**Measure:** Professional Quality of Life

**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up

**Description:** 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.

**Measure:** Intention to Quit

**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up

### Eligibility Module

**Eligibility Criteria:** 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).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Zip:** 48104

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000009784

- Term: Occupational Diseases

- ID: D000013315

- Term: Stress, Psychological

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC24

- Name: Occupational Diseases

### Condition Browse Module - Browse Leaves

- ID: M5326

- Name: Burns

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Posttraumatic Stress Disorder

- ID: M1167

- Name: Occupational Stress

- Relevance: HIGH

- As Found: Work Related Stress

- ID: M1658

- Name: Burnout, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depressive Symptoms

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M12719

- Name: Occupational Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000073397

- Term: Occupational Stress

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

- ID: D000003863

- Term: Depression

### Misc Info Module

- Version Holder: 2024-05-31
