Trauma-Focused Intervention With Women Experiencing Homelessness

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873517
• Other study ID #: 22060903-IRB01
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: Rush University Medical Center
• Contact: Kirsten A Dickins, PhD
• Phone: 312-942-0782
• Email: kirsten_dickins[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. self-identifies as a woman;

2. greater than or equal to 18 years;

3. positive screen on TAPS-1 (reflecting problematic substance use);

4. recently (within 1 year) or currently homeless (HRSA definition);

5. 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)

Related Conditions & MeSH terms

• Disease
• Psychological Trauma
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders
• Trauma and Stressor Related Disorders
• Wounds and Injuries

Intervention

Behavioral:
• Immediate 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.
• Waitlist + 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+).

Locations

Country	Name	City	State
United States	Deborah's Place	Chicago	Illinois
United States	Sarah's Circle	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Traumatic Stress Disorder Symptoms	PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome	6 weeks
Secondary	Depression	Patient Health Questionnaire-9, range 0-27, higher scores = worse outcome	6 weeks
Secondary	Anxiety	Generalized Anxiety Disorder 7-item (GAD-7), range 0-27, higher scores = worse outcome	6 weeks
Secondary	Sleep Problems	Insomnia Severity Index (ISI), range 0-28, higher scores = worse outcome	6 weeks
Secondary	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