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Trauma-Focused Intervention With Women Experiencing Homelessness

NCT ID: NCT05873517

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-03-30

Brief Summary

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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

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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.

Conditions

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

Keywords

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Homelessness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Immediate NET+

Receives NET+ immediately

Group Type EXPERIMENTAL

Immediate Narrative Exposure Therapy (NET)+

Intervention Type BEHAVIORAL

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

Waitlist NET+

Receives NET+ after waitlist

Group Type ACTIVE_COMPARATOR

Waitlist + NET+

Intervention Type 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+).

Interventions

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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.

Intervention Type 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+).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Deborah's Place

Chicago, Illinois, United States

Site Status

Sarah's Circle

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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22060903-IRB01

Identifier Type: -

Identifier Source: org_study_id