Intervention Evaluation WEH (Women Who Have Experienced Homelessness)

NCT ID: NCT06570525

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2029-12-31

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

NurseNET

Intervention Type: BEHAVIORAL

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

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).

Group Type: ACTIVE_COMPARATOR

PAL

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten A Dickins, PhD, FNP-C

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Other Identifiers

24061301

Identifier Type: -

Identifier Source: org_study_id