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

NCT04605198 | Completed Results DMC

• 2 other identifiers: 2019-56075K01MD013910
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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. 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. 2.Compared to an attention control, participants in an MBSR-based intervention group will demonstrate improvements in cortisol reactivity and lower inflammation.

Conditions

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

Keywords

PTSD; Trauma

Outcome Measures

Primary Outcomes (1)

• Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders).

  Change in Posttraumatic Stress Symptoms Disorder symptoms (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.

  Immediately post-intervention & 6-month follow-up

Secondary Outcomes (5)

• Depression

  Immediately post-intervention & 6-month follow-up

• Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5)

  Immediately post-intervention & 6-month follow-up

• Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup

  Immediately post-intervention & 6-month follow-up

• Cortisol Reactivity

  Immediately post-intervention & 6-month follow-up

• C-Reactive Protein (CRP)

  Immediately post-intervention & 6-month follow-up

Study Arms (2)

Modified Mindfulness-based Stress Reduction

EXPERIMENTAL

Behavioral: Modified Mindfulness-based Stress Reduction

Health Promotion Attention Control

ACTIVE COMPARATOR

Behavioral: Health Promotion Wellness Classes

Interventions

Modified Mindfulness-based Stress Reduction BEHAVIORAL

Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration \& Awareness; Session 5: Unhealthy Patterns \&Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline \& Flexibility; Session 9: Course Review.

Also known as: modified MBSR

Modified Mindfulness-based Stress Reduction

Health Promotion Wellness Classes BEHAVIORAL

Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration \& Course Graduation.

Health Promotion Attention Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women are eligible for the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

North County Serenity House

Escondido, California, 92026, United States

Location

Prototypes Women's Center

Pomona, California, 91767, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Limitations and Caveats

Participants were not assigned on a 1:1 ratio. Some courses lasted more than 8 weeks due to vacillating quarantines and lockdowns during COVID-19 outbreaks. Relatedly, participants who were discharged from the site were not allowed to participate in follow-up sessions due to COVID-19 quarantines in 2020-2021, contributing to increased attrition over time. Additional MBSR participants were enrolled to adjust for this, allowing for adequate power but resulting in an unbalanced design.

Results Point of Contact

• Title: Dr. Dana Rose Garfin, Associate Professor
• Organization: University of California, Los Angeles

dgarfin@ucla.edu

415-407-9498

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: October 6, 2020
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: March 11, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-02

Locations

US (2)