Intervention Evaluation WEH (Women Who Have Experienced Homelessness)

Phase 1

Withdrawn

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: NurseNET; Other: PAL

• Registration Number: NCT06570525
• Lead Sponsor: Rush University Medical Center

Brief Summary

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).

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 Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Start: 2025-05
• Primary Completion: 2029-06
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 420

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NurseNET-Narrative Exposure Therapy	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.
PAL: Peer Active Listening	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)	Patient Depression Questionnaire (PHQ-9). Higher score = worse outcome. Range: 0-27.
Sleep symptoms	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)	Regensburg Insomnia Scale (RIS). Higher score = worse outcome. Range: 0-40.
Anxiety	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)	Generalized Anxiety Disorder (GAD-7). Higher score = worse outcome. Range: 0-21.
Somatization	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)	Somatic Symptoms Scale (SSS-8). Higher score = worse outcome. Range: 0-32.
Substance use	Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)	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.