Trauma-Focused Intervention With Women Experiencing Homelessness

NCT05873517 | Withdrawn Phase 1

• 1 other identifier: 22060903-IRB01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychological Trauma; Trauma and Stress Related Disorders; Substance-Related Disorders; Substance Use; Substance Use Disorders

Keywords

Homelessness

Outcome Measures

Primary Outcomes (1)

• Post-Traumatic Stress Disorder Symptoms

  PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome

  6 weeks

Secondary Outcomes (4)

• Depression

  6 weeks

• Anxiety

  6 weeks

• Sleep Problems

  6 weeks

• Substance Use

  6 weeks

Study Arms (2)

Immediate NET+

EXPERIMENTAL

Receives NET+ immediately

Behavioral: Immediate Narrative Exposure Therapy (NET)+

Waitlist NET+

ACTIVE COMPARATOR

Receives NET+ after waitlist

Behavioral: Waitlist + NET+

Interventions

Immediate Narrative Exposure Therapy (NET)+ BEHAVIORAL

The basis of this intervention is adapted Narrative Exposure Therapy (NET)+. All participants receive 4-8 active NET+ sessions, including a psychoeducational session.

Immediate NET+

Waitlist + NET+ BEHAVIORAL

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+).

Waitlist NET+

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-identifies as "woman"
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Deborah's Place

Chicago, Illinois, 60612, United States

Location

Sarah's Circle

Chicago, Illinois, 60640, United States

Location

MeSH Terms

Conditions

Psychological Trauma; Trauma and Stressor Related Disorders; Substance-Related Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will either receive immediate NET+ or be assigned to a waitlist; all participants will be offered the opportunity to enroll in the NET+ intervention.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 24, 2023
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

US (2)