Trauma-Focused Intervention With Women Experiencing Homelessness

Phase 1

Withdrawn

• Conditions: Trauma and Stress Related Disorders; Substance-Related Disorders; Psychological Trauma; Substance Use; Substance Use Disorders
• Interventions: Behavioral: Waitlist + NET+; Behavioral: Immediate Narrative Exposure Therapy (NET)+

• Registration Number: NCT05873517
• Lead Sponsor: Rush University Medical Center

Brief Summary

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

Detailed Description

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. We have systematically adapted a trauma-focused intervention protocol (Narrative Exposure Therapy \[NET\]) to the self-identified needs and preferences of trauma-affected women experiencing homelessness. This adapted intervention, "NET+", incorporates strengths and preferences identified by women themselves, embedding principles of cognitive behavioral therapy (CBT) into conventional NET. NET+ aims to both employ core NET principles to re-process past trauma in parallel with building present-centered skills to address avoidant coping motives in PTSD+SUD. Via a pragmatic, waitlist randomized controlled trial, we will further assess the feasibility, acceptability, and preliminary effects of a 3-week NET+ intervention protocol with up to 100 women experiencing homelessness. We will determine pre- and post-NET+ intervention PTSD and trauma-related symptom scores (depression, anxiety, somatization, sleep), substance use behaviors, and effect sizes. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• self-identifies as a woman;
• greater than or equal to 18 years;
• positive screen on TAPS-1 (reflecting problematic substance use);
• recently (within 1 year) or currently homeless (HRSA definition);
• affected by a traumatic life event and trauma-related distress (+Life Events Checklist for DSM-5 Standard [LEC-5] response ≥1 and PTSD Checklist for DSM-5 [PCL-5] score ≥28).

Exclusion Criteria

• impaired decisional capacity to consent to participation (University of California, San Diego Brief Assessment of Capacity to Consent [UBACC] score ≤14.5)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Waitlist NET+	Waitlist + NET+	Receives NET+ after waitlist
Immediate NET+	Immediate Narrative Exposure Therapy (NET)+	Receives NET+ immediately

Primary Outcome Measures

Name	Time	Method
Post-Traumatic Stress Disorder Symptoms	6 weeks	PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome

Secondary Outcome Measures

Name	Time	Method
Depression	6 weeks	Patient Health Questionnaire-9, range 0-27, higher scores = worse outcome
Anxiety	6 weeks	Generalized Anxiety Disorder 7-item (GAD-7), range 0-27, higher scores = worse outcome
Sleep Problems	6 weeks	Insomnia Severity Index (ISI), range 0-28, higher scores = worse outcome
Substance Use	6 weeks	Tobacco, Alcohol, Prescription substance use behaviors, medication, and other Substance use Tool (positive/negative screen - positive screen = using substances/worse outcomes)

Trial Locations

Locations (2)

Deborah's Place; 🇺🇸 Chicago, Illinois, United States

Sarah's Circle; 🇺🇸 Chicago, Illinois, United States