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

NCT ID: NCT04605198

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2023-06-22

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Mindfulness-based Stress Reduction

Group Type: EXPERIMENTAL

Modified Mindfulness-based Stress Reduction

Intervention Type: 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.

Health Promotion Attention Control

Group Type: ACTIVE_COMPARATOR

Health Promotion Wellness Classes

Intervention Type: 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.

Interventions

Modified Mindfulness-based Stress Reduction

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.

Intervention Type: BEHAVIORAL

Health Promotion Wellness Classes

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

modified MBSR

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Dana Rose Garfin

Assistant Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

North County Serenity House

Escondido, California, United States

Prototypes Women's Center

Pomona, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5K01MD013910

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-5607

Identifier Type: -

Identifier Source: org_study_id