Intervention Evaluation WEH (Women Who Have Experienced Homelessness)
NCT Number: NCT06570525
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Posttraumatic Stress Disorder
Interventions: BEHAVIORAL: NurseNET|OTHER: PAL
Sponsor: Rush University Medical Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-12

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).

Primary Outcome Measures: 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: 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: 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)