Clinical trial NCT05873517: Trauma-Focused Intervention With Women Experiencing Homelessness
Official title: Pragmatic, Waitlist Randomized Controlled Trial of a Trauma-Focused Intervention With Women Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Psychological Trauma
Trauma and Stress Related Disorders
Substance-Related Disorders
Substance Use
Substance Use Disorders
Keywords: Homelessness
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Institutes of Health (NIH)
First posted: 2023-05-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Post-Traumatic Stress Disorder Symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: Depression
timeFrame: 6 weeks
measure: Anxiety
timeFrame: 6 weeks
measure: Sleep Problems
timeFrame: 6 weeks
measure: Substance Use
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Deborah's Place
state: Illinois
city: Chicago
country: United States
facility: Sarah's Circle
state: Illinois
Study officials:
References: