Clinical Trial: Trauma-Focused Intervention With Women Experiencing Homelessness

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Pragmatic, Waitlist Randomized Controlled Trial of a Trauma-Focused Intervention With Women Experiencing 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 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.
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.
Sponsor: Rush University Medical Center

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

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

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rush University Medical Center

Dates:
Date Received: April 12, 2023
Date Started: April 12, 2023
Date Completion: April 12, 2023
Last Updated: May 15, 2023
Last Verified: May 01, 2023