Trauma-Focused Intervention With Women Experiencing Homelessness

Pragmatic, Waitlist Randomized Controlled Trial of a Trauma-Focused Intervention With Women Experiencing Homelessness

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.

Study Overview

• Status: Withdrawn
• Conditions: Substance-Related Disorders; Substance Use; Substance Use Disorders; Psychological Trauma; Trauma and Stress Related Disorders
• Intervention / Treatment: Behavioral: Immediate Narrative Exposure Therapy (NET)+; Behavioral: Waitlist + NET+

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Deborah's Place
    • Chicago, Illinois, United States, 60640
      • Sarah's Circle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate NET+; Receives NET+ immediately	Behavioral: Immediate Narrative Exposure Therapy (NET)+; The basis of this intervention is adapted Narrative Exposure Therapy (NET)+. All participants receive 4-8 active NET+ sessions, including a psychoeducational session.
Active Comparator: Waitlist NET+; Receives NET+ after waitlist	Behavioral: Waitlist + NET+; Waitlist control group participants receive 1 psychoeducational sessions and will be added to a waitlist; waitlist control group participants randomly selected from the waitlist be offered the opportunity to receive the active intervention (NET+).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Homelessness
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Psychological Trauma; Trauma and Stressor Related Disorders; Substance-Related Disorders; Wounds and Injuries
• Other Study ID Numbers: 22060903-IRB01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No