Clinical trial NCT06570525: Intervention Evaluation WEH (Women Who Have Experienced Homelessness)
Official title: Improving Traumatic Stress in Women Who Have Experienced Homelessness: Evaluation of a Stakeholder Engaged Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Posttraumatic Stress Disorder (PTSD) symptoms
timeFrame: Eligibility Screening; Pre-/Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
measure: Anxiety
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
measure: Sleep symptoms
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
measure: Somatization
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
measure: Substance use
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
Other outcomes:
measure: Healthcare access
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4)
measure: Perceived social support
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16)
measure: Discrimination
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4)
measure: Racial trauma
timeFrame: Pre-Assessment (week 0), Post-Assessment (week 4)
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Kirsten A Dickins, PhD, FNP-C
role: PRINCIPAL_INVESTIGATOR
References: