Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Pomona, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Dana Rose Garfin

Description

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.

Keywords

Stress Disorders, Post-Traumatic Depressive Symptoms Hydrocortisone Substance Use PTSD Trauma Depression Modified Mindfulness-based Stress Reduction Health Promotion Wellness Classes

Eligibility

You can join if…

Open to females ages 18 years and up

  1. self-reported homeless women
  2. age 18-64
  3. willing to provide informed consent
  4. lifetime exposure to at least one DSM-V qualifying trauma
  5. 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.

You CAN'T join if...

  1. not speaking English
  2. judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).

Locations

  • Prototypes Women's Center accepting new patients
    Pomona California 91767 United States
  • North County Serenity House not yet accepting patients
    Escondido California 92026 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04605198
Study Type
Interventional
Last Updated