Trauma-Focused Intervention With Women Experiencing Homelessness

Study Overview
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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.

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

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

Intervention / Treatment
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* Behavioral: Immediate Narrative Exposure Therapy (NET)+
* Behavioral: Waitlist + NET+


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate NET+<br>Receives NET+ immediately | Behavioral: Immediate Narrative Exposure Therapy (NET)+<br>* The basis of this intervention is adapted Narrative Exposure Therapy (NET)+. All participants receive 4-8 active NET+ sessions, including a psychoeducational session.<br>|
| Active Comparator: Waitlist NET+<br>Receives NET+ after waitlist | Behavioral: Waitlist + NET+<br>* 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+).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homelessness