Trauma-Focused Intervention With Women Experiencing Homelessness

Sponsor

Rush University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05873517

Collaborator

National Center for Advancing Translational Sciences (NCATS) (NIH), National Institutes of Health (NIH) (NIH)

Enrollment

Locations

Arms

16.7

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Psychological Trauma Trauma and Stress Related Disorders Substance-Related Disorders Substance Use Substance Use Disorders	Behavioral: Immediate Narrative Exposure Therapy (NET)+ Behavioral: Waitlist + NET+	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 12, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate NET+ Receives NET+ immediately	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.
Active Comparator: Waitlist NET+ Receives NET+ after waitlist	Behavioral: 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+).

Arm

Intervention/Treatment

Experimental: Immediate NET+

Receives NET+ immediately

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.

Active Comparator: Waitlist NET+

Receives NET+ after waitlist

Behavioral: 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+).

Outcome Measures

Primary Outcome Measures

Post-Traumatic Stress Disorder Symptoms [6 weeks]
PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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:

(1) impaired decisional capacity to consent to participation (University of California, San Diego Brief Assessment of Capacity to Consent [UBACC] score ≤14.5)