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

Not Applicable

Completed

• Conditions: Hydrocortisone; Stress Disorders, Post-Traumatic; Substance Use; Depressive Symptoms
• Interventions: Behavioral: Health Promotion Wellness Classes; Behavioral: Modified Mindfulness-based Stress Reduction

• Registration Number: NCT04605198
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 158

Inclusion Criteria

1. self-reported homeless women
2. age 18+
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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Promotion Attention Control	Health Promotion Wellness Classes	-
Modified Mindfulness-based Stress Reduction	Modified Mindfulness-based Stress Reduction	-

Primary Outcome Measures

Name	Time	Method
Post-traumatic Stress Symptoms	Immediately post-intervention & 6-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Depression	Immediately post-intervention & 6-month follow-up	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.
Substance Use (self-report)	Immediately post-intervention & 6-month follow-up	Change in substance use from baseline to follow-ups using the Texas Christian University Screen
Substance Use (objective)	Immediately post-intervention & 6-month follow-up	Change in substance use from baseline to follow-up using 5-panel FDA-approved urine test cup
Cortisol reactivity	Immediately post-intervention & 6-month follow-up	Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics).
C-Reactive Protein (CRP)	Immediately post-intervention & 6-month follow-up	Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay.

Trial Locations

Locations (2)

North County Serenity House; 🇺🇸 Escondido, California, United States

Prototypes Women's Center; 🇺🇸 Pomona, California, United States