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

University of California, Los Angeles (UCLA)

Status: Completed

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

Treatments: Behavioral: Modified Mindfulness-based Stress Reduction; Behavioral: Health Promotion Wellness Classes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04605198

2019-5607

5K01MD013910 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. self-reported homeless women
2. age 18+
3. willing to provide informed consent
4. lifetime exposure to at least one Diagnostic and Statistical Manuel of Mental Disorders, version 5 (DSM-5) qualifying trauma
5. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Modified Mindfulness-based Stress Reduction

Experimental group

Treatment:

Behavioral: Modified Mindfulness-based Stress Reduction

Health Promotion Attention Control

Active Comparator group

Treatment:

Behavioral: Health Promotion Wellness Classes