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N/A N=156 Randomized Treatment

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

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

Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). — 26.93; 30.75; 24.46; 28.33 score on a scale — p=.846

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Modified Mindfulness-based Stress Reduction (Behavioral); Health Promotion Wellness Classes (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of California, Los Angeles
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders).
26.93; 30.75; 24.46; 28.33 .846
SECONDARY
Depression
13.19; 17.98; 11.98; 16.97 .139
SECONDARY
Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5)
0.68; 1.71; 1.24; 1.28 .222
SECONDARY
Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup
4; 3; 2; 3 0.166
SECONDARY
Cortisol Reactivity
-2.10; -0.70; -2.45; -1.76 .737
SECONDARY
C-Reactive Protein (CRP)
2395.32; 1725.80; 3950.69; 1248.06 .024 sig

Summary

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: 1. 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. 2. 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.

Eligibility Criteria

Inclusion Criteria

  • self-reported homeless women
  • age 18+
  • willing to provide informed consent
  • lifetime exposure to at least one Diagnostic and Statistical Manuel of Mental Disorders, version 5 (DSM-5) qualifying trauma
  • likely subthreshold or threshold PTSD, as measured by the PTSD Checklist for Civilians for DSM-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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04605198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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