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Trauma-Focused Intervention With Women Experiencing Homelessness

Primary Purpose

Psychological Trauma, Trauma and Stress Related Disorders, Substance-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Narrative Exposure Therapy (NET)+
Waitlist + NET+
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychological Trauma focused on measuring Homelessness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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: (1) impaired decisional capacity to consent to participation (University of California, San Diego Brief Assessment of Capacity to Consent [UBACC] score ≤14.5)

Sites / Locations

  • Deborah's PlaceRecruiting
  • Sarah's CircleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate NET+

Waitlist NET+

Arm Description

Receives NET+ immediately

Receives NET+ after waitlist

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression
Patient Health Questionnaire-9, range 0-27, higher scores = worse outcome
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7), range 0-27, higher scores = worse outcome
Sleep Problems
Insomnia Severity Index (ISI), range 0-28, higher scores = worse outcome
Substance Use
Tobacco, Alcohol, Prescription substance use behaviors, medication, and other Substance use Tool (positive/negative screen - positive screen = using substances/worse outcomes)

Full Information

First Posted
April 12, 2023
Last Updated
May 15, 2023
Sponsor
Rush University Medical Center
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05873517
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma, Trauma and Stress Related Disorders, Substance-Related Disorders, Substance Use, Substance Use Disorders
Keywords
Homelessness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate NET+
Arm Type
Experimental
Arm Description
Receives NET+ immediately
Arm Title
Waitlist NET+
Arm Type
Active Comparator
Arm Description
Receives NET+ after waitlist
Intervention Type
Behavioral
Intervention Name(s)
Immediate Narrative Exposure Therapy (NET)+
Intervention Description
The basis of this intervention is adapted Narrative Exposure Therapy (NET)+. All participants receive 4-8 active NET+ sessions, including a psychoeducational session.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist + NET+
Intervention Description
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+).
Primary Outcome Measure Information:
Title
Post-Traumatic Stress Disorder Symptoms
Description
PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
Patient Health Questionnaire-9, range 0-27, higher scores = worse outcome
Time Frame
6 weeks
Title
Anxiety
Description
Generalized Anxiety Disorder 7-item (GAD-7), range 0-27, higher scores = worse outcome
Time Frame
6 weeks
Title
Sleep Problems
Description
Insomnia Severity Index (ISI), range 0-28, higher scores = worse outcome
Time Frame
6 weeks
Title
Substance Use
Description
Tobacco, Alcohol, Prescription substance use behaviors, medication, and other Substance use Tool (positive/negative screen - positive screen = using substances/worse outcomes)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-identifies as "woman"
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: (1) impaired decisional capacity to consent to participation (University of California, San Diego Brief Assessment of Capacity to Consent [UBACC] score ≤14.5)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten A Dickins, PhD
Phone
312-942-0782
Email
kirsten_dickins@rush.edu
Facility Information:
Facility Name
Deborah's Place
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharine Booton Wilson
Facility Name
Sarah's Circle
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Lopez

12. IPD Sharing Statement

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Trauma-Focused Intervention With Women Experiencing Homelessness

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