Intervention Evaluation WEH (Women Who Have Experienced Homelessness)

Improving Traumatic Stress in Women Who Have Experienced Homelessness: Evaluation of a Stakeholder Engaged Intervention

Homelessness and associated traumas disproportionately impact women relative to men. Women who have experienced homelessness (WEH) universally face traumatic stress, often before becoming homeless and while experiencing homelessness.

For WEH who are incarcerated, additional trauma may occur while in correctional settings. Black WEH are disproportionately impacted by trauma, homelessness, and incarceration, as is related to structural and individual racism and discrimination (racial trauma).

Study Overview

• Status: Withdrawn
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: NurseNET; Other: PAL

Detailed Description

Homelessness and associated traumas disproportionately impact women relative to men. Women who have experienced homelessness (WEH) universally face traumatic stress, often before becoming homeless and while experiencing homelessness. For WEH who are incarcerated, additional trauma may occur while in correctional settings. Black WEH are disproportionately impacted by trauma, homelessness, and incarceration, as is related to structural and individual racism and discrimination (racial trauma). In our stepwise, multi-year research process, across hundreds of interviews, WEH identified trauma as their priority health issue. In response to a dearth of culturally acceptable trauma care models, our team pilot tested Narrative Exposure Therapy (NET)-a brief, human rights-informed treatment for complex PTSD in resource-limited settings. In this randomized controlled trial (RCT), we seek to understand whether supplementing nurse-delivered NET with peer/program support will strengthen its effects on PTSD, co-occurring symptoms, and social determinants of health outcomes compared to an attentional control, while optimizing implementation outcomes.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• self-identifies as a woman
• ≥18 years of age
• history of homelessness or currently experiencing homelessness (HRSA criteria)
• affected by trauma-related distress (≥1 on Life Events Checklist + PTSD Checklist for DSM-5 ≥28)
• at least 75% of the sample must self-identify as Black/African American

Exclusion Criteria:

• impaired decisional capacity (UC-San Diego Brief Assessment ≤14.5)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NurseNET-Narrative Exposure Therapy; Nurse-Delivered Narrative Exposure Therapy (NurseNET). Narrative Exposure Therapy (NET) is a brief, low-cost, trauma-focused treatment modality that is effective in treating mobile populations with complex PTSD. In NurseNET, NET is facilitated by a clinically experienced nurse, while peers/program support specialists offer scaffolded support, fostering trust, engagement, and retention. NurseNET begins with administration of a "diagnostic battery" and psychoeducation. Then, in subsequent NurseNET sessions, using gradual imaginative exposure, the nurse guides the participant to verbally express and re-frame their personal trauma narratives to shift unhelpful beliefs/symptoms around trauma. NurseNET utilizes a racism-conscious approach to create relational spaces in which narratives of WEH are positioned to challenge dominant social narratives. Each NurseNET session offers a brief soulfulness-based stress reduction activity to prompt emotional/affective grounding.	Behavioral: NurseNET; Nurse-Delivered Narrative Exposure Therapy (NurseNET). Narrative Exposure Therapy (NET) is a brief, low-cost, trauma-focused treatment modality that is effective in treating mobile populations with complex PTSD. In NurseNET, NET is facilitated by a clinically experienced nurse, while peers/program support specialists offer scaffolded support, fostering trust, engagement, and retention. NurseNET begins with administration of a "diagnostic battery" and psychoeducation. Then, in subsequent NurseNET sessions, using gradual imaginative exposure, the nurse guides the participant to verbally express and re-frame their personal trauma narratives to shift unhelpful beliefs/symptoms around trauma. NurseNET utilizes a racism-conscious approach to create relational spaces in which narratives of WEH are positioned to challenge dominant social narratives. Each NurseNET session offers a brief soulfulness-based stress reduction activity to prompt emotional/affective grounding.
Active Comparator: PAL: Peer Active Listening; Peer Active Listening (PAL). In the PAL active comparator/control, peers/program support specialists meet individually with participants in "active listening sessions", along the same visit sequence as NurseNET. During PAL sessions, peers/program support specialists allow participants to set each conversational agenda while practicing the tenets of active listening, including attending to body language, paraphrasing the participant's verbal expressions, reflecting feelings, and using tactful repetition. PAL sessions are not intended to center on topics of trauma, but rather designed to offer a supportive relationship (attentional control).	Other: PAL; Peer Active Listening (PAL). In the PAL active comparator/control, peers/program support specialists meet individually with participants in "active listening sessions", along the same visit sequence as NurseNET. During PAL sessions, peers/program support specialists allow participants to set each conversational agenda while practicing the tenets of active listening, including attending to body language, paraphrasing the participant's verbal expressions, reflecting feelings, and using tactful repetition. PAL sessions are not intended to center on topics of trauma, but rather designed to offer a supportive relationship (attentional control).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic Stress Disorder (PTSD) symptoms	PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5). Higher score = worse outcome. Range: 0-80.	Eligibility Screening; Pre-/Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Patient Depression Questionnaire (PHQ-9). Higher score = worse outcome. Range: 0-27.	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Anxiety	Generalized Anxiety Disorder (GAD-7). Higher score = worse outcome. Range: 0-21.	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Sleep symptoms	Regensburg Insomnia Scale (RIS). Higher score = worse outcome. Range: 0-40.	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Somatization	Somatic Symptoms Scale (SSS-8). Higher score = worse outcome. Range: 0-32.	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Substance use	Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool. TAPS-1, is a four-item screening that asks about substance use in the past 12 months.	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare access	Barriers to Access to Care Evaluation Scale (BACE). Higher score = worse outcome (greater barrier to seeking treatment). Range: 0-90. 30-items, 12-item subscale measures the extent to which stigma and discrimination are barriers to care.	Pre-Assessment (week 0), Post-Assessment (week 4)
Perceived social support	Multidimensional Scale of Perceived Social Support Scale (MSPSS). Higher score = better. Range: 0-60.	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Discrimination	Everyday/Major Experiences of Discrimination Scale (EDS/MDS). This measure contains nine elements that assess the participant's perception of major experiences of discrimination, followed by a follow-up question about what the person believes was the reason for that discrimination (no numeric scoring).	Pre-Assessment (week 0), Post-Assessment (week 4)
Racial trauma	Racial Trauma Scale (RTS) (short form research version). Higher score = worse. Range: 9-36.	Pre-Assessment (week 0), Post-Assessment (week 4)

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Kirsten A Dickins, PhD, FNP-C, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 24061301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No