Psychological Trauma, Substance-Related Disorders, Substance Use, Substance Use Disorders, Trauma and Stress Related Disorders
Conditions
Keywords
Homelessness
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.
Interventions
BEHAVIORALImmediate 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.
BEHAVIORALWaitlist + 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+).
Sponsors
National Center for Advancing Translational Sciences (NCATS)
National Institutes of Health (NIH)
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Traumatic Stress Disorder Symptoms | 6 weeks | PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed