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Intervention Evaluation WEH (Women Who Have Experienced Homelessness)

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

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06570525
Enrollment
0
Registered
2024-08-26
Start date
2025-05-31
Completion date
2029-12-31
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

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.

Interventions

BEHAVIORALNurseNET

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.

OTHERPAL

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).

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Posttraumatic Stress Disorder (PTSD) symptomsEligibility 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

MeasureTime frameDescription
AnxietyPre-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.
Depressive symptomsPre-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 symptomsPre-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.
SomatizationPre-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 usePre-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.

Other

MeasureTime frameDescription
Perceived social supportPre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)Multidimensional Scale of Perceived Social Support Scale (MSPSS). Higher score = better. Range: 0-60.
DiscriminationPre-Assessment (week 0), Post-Assessment (week 4)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).
Healthcare accessPre-Assessment (week 0), Post-Assessment (week 4)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.
Racial traumaPre-Assessment (week 0), Post-Assessment (week 4)Racial Trauma Scale (RTS) (short form research version). Higher score = worse. Range: 9-36.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026