Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women

Study Overview
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Brief Summary
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Posttraumatic stress disorder (PTSD) is a major public health concern that disproportionately effects minorities and those with low-socioeconomic status, such as homeless women, creating a critical health disparity. PTSD has been linked with dysregulated hypothalamic-pituitary-adrenal (HPA) functioning and increased inflammation, which can lead to long-term physical-health problems and PTSD-symptom maintenance, exacerbating disparities. Mindfulness-based interventions, including Mindfulness-based Stress Reduction (MBSR), have shown promise as a complementary tool for addressing PTSD in veterans and with low-income, minority populations, but homeless women have not been examined adequately. MBSR may improve PTSD symptomatology and help modulate the dysregulated stress response common in individuals with PTSD, improving physical and mental health concurrently. This project is an open-label, parallel, modified-cross over clinical trial of a modified-MBSR intervention to reduce PTSD symptoms in homeless women and to explore physiological correlates of treatment-response. Hypotheses: Participation in an MBSR-based intervention will be associated with clinically significant reduction in PTSD (primary outcome), lower depression symptoms and greater drug and alcohol abstinence (secondary outcomes) compared to participation in an attention control. Compared to an attention control, participants in an MBSR-based intervention group will demonstrate improvements in cortisol reactivity and lower inflammation. At baseline, women will complete psychosocial assessments (e.g., depression, substance use, trauma history) and participate in a brief stress task, providing salivary samples before and after the task (which will be assayed for cortisol and C-reactive protein, a marker of inflammation). Women will then participate in 1) a 9-session MBSR-based program that was modified based on an initial qualitative component that involved a Community Advisory Board and focus groups with women from the community (N=4 focus groups; 28 women total) or 2) a nine-session health-promotion course (i.e., attention-control condition). Follow-up assessments that include psychosocial and biological data will occur immediately after final intervention session and again 6-months later. Clinically-meaningful improvements in PTSD (primary outcome) and secondary outcomes (e.g., depression, substance use, inflammation, cortisol reactivity) will be examined.

Official Title
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Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women

Conditions
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Stress Disorders, Post-Traumatic, Depressive Symptoms, Hydrocortisone, Substance Use

Intervention / Treatment
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* Behavioral: Modified Mindfulness-based Stress Reduction
* Behavioral: Health Promotion Wellness Classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-reported homeless women age 18+ willing to provide informed consent lifetime exposure to at least one DSM-V qualifying trauma likely subthreshold or threshold PTSD, as measured by the PCL-5. Note: A homeless person is defined as anyone who spent the previous night in a public or private shelter, or on the street. Exclusion Criteria: not speaking English judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be recruited from two sites. To avoid contamination between subjects living at the sites, using a quasi-randomized method, all participants at each site will receive the same treatment per cohort. Sites will alternate between the assignment of treatment (modified-MBSR) or control (health promotion class) in sequential cohorts to account for between site differences.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Mindfulness-based Stress Reduction<br> | Behavioral: Modified Mindfulness-based Stress Reduction<br>* Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review.<br>* Other names: modified MBSR;|
| Active Comparator: Health Promotion Attention Control<br> | Behavioral: Health Promotion Wellness Classes<br>* Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-traumatic Stress Symptoms | Clinically significant improvement in Posttraumatic Stress Symptoms - PTS (i.e., decrease in symptoms), as measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). The PCL-5 is a 20-item scale (range 0-80), with rating scale descriptions: 0 Not at all, 1 A little bit, 2 Moderately, 3 Quite a bit, and 4 Extremely. Higher scores indicate more PTSD symptoms. | Immediately post-intervention & 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Change in depressive symptoms from baseline to follow-ups (i.e., decrease in symptoms), using the Patient Reported Outcomes Measurement Information System (PROMIS) measure for depression. The PROMIS asks 9-items (range 9-45) with response options: 1 never, 2 rarely, 3 sometimes, 4 often, and 5 always. Higher scores indicate more symptoms of depression. | Immediately post-intervention & 6-month follow-up | 
| Substance Use (self-report) | Change in substance use from baseline to follow-ups using the Texas Christian University Screen | Immediately post-intervention & 6-month follow-up | 
| Substance Use (objective) | Change in substance use from baseline to follow-up using 5-panel FDA-approved urine test cup | Immediately post-intervention & 6-month follow-up | 
| Cortisol reactivity | Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics). | Immediately post-intervention & 6-month follow-up | 
| C-Reactive Protein (CRP) | Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. | Immediately post-intervention & 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Trauma