Clinical trial NCT04605198: Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
Official title: Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depressive Symptoms
Hydrocortisone
Substance Use
Keywords: PTSD
Trauma
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-10-27
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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:

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).

Primary outcomes:
measure: Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders).
timeFrame: Immediately post-intervention & 6-month follow-up
Secondary outcomes:
measure: Depression
timeFrame: Immediately post-intervention & 6-month follow-up
measure: Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5)
timeFrame: Immediately post-intervention & 6-month follow-up
measure: Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup
timeFrame: Immediately post-intervention & 6-month follow-up
measure: Cortisol Reactivity
timeFrame: Immediately post-intervention & 6-month follow-up
measure: C-Reactive Protein (CRP)
timeFrame: Immediately post-intervention & 6-month follow-up
Other outcomes:
Locations:
city: Escondido
country: United States
facility: North County Serenity House
state: California
city: Pomona
country: United States
facility: Prototypes Women's Center
state: California
Study officials:
References: