Trauma-Focused Intervention With Women Experiencing Homelessness

Rush

Status and phase: Withdrawn; Phase 1

Conditions: Substance Use; Substance Use Disorders; Substance-Related Disorders; Trauma and Stress Related Disorders; Psychological Trauma

Treatments: Behavioral: Waitlist + NET+; Behavioral: Immediate Narrative Exposure Therapy (NET)+

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05873517

22060903-IRB01

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Immediate NET+

Experimental group

Description:

Receives NET+ immediately

Treatment:

Behavioral: Immediate Narrative Exposure Therapy (NET)+

Waitlist NET+

Active Comparator group

Description:

Receives NET+ after waitlist

Treatment:

Behavioral: Waitlist + NET+