Depressive Symptoms, Hydrocortisone, Stress Disorders, Post-Traumatic, Substance Use
Conditions
Keywords
PTSD, Trauma
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.
Interventions
BEHAVIORALModified 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.
BEHAVIORALHealth 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Immediately post-intervention & 6-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | Change in continues measure of self-report substance use from baseline to follow-ups using the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5). The possible range for the score is 1-11. Participants respond to a series of 13 possible no (0) or yes (1) questions, with two questions counting for a maximum score of 1 each. Higher scores indicate more severe substance use. |
| Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Immediately post-intervention & 6-month follow-up | Count of participants with positive 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). Higher scores indicate more change in cortisol. |
| 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. Higher scores indicate higher concentration of CRP. |
Countries
United States
Participant flow
Pre-assignment details
192 participants were assessed for eligibility. Of those, 13 did not experience homelessness, 10 were cognitively impaired, 3 did not meet criteria for subthreshold PTSD, and 10 were eligible but did not enroll.
Participants by arm
| Arm | Count |
|---|---|
| Modified Mindfulness-based Stress Reduction 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. | 90 |
| Health Promotion Attention Control 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. | 66 |
| Total | 156 |
Baseline characteristics
| Characteristic | Modified Mindfulness-based Stress Reduction | Health Promotion Attention Control | Total |
|---|---|---|---|
| Age, Continuous | 35.52 Years STANDARD_DEVIATION 9.79 | 35.18 Years STANDARD_DEVIATION 11.23 | 35.38 Years STANDARD_DEVIATION 10.39 |
| Cortisol reactivity | -.912 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 2.32 | -.617 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 2.41 | -.789 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 2.35 |
| C-Reactive Protein (CRP) | 4639.62 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 9332.93 | 1330.49 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 2160.09 | 3239.60 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 7393.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 29 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 37 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean PROMIS Depression | 17.72 units on a scale STANDARD_DEVIATION 8.28 | 20.42 units on a scale STANDARD_DEVIATION 8.8 | 18.87 units on a scale STANDARD_DEVIATION 8.58 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety | 20.88 units on a scale STANDARD_DEVIATION 6.67 | 22.12 units on a scale STANDARD_DEVIATION 7.04 | 21.40 units on a scale STANDARD_DEVIATION 6.84 |
| Posttraumatic Stress Disorder Checklist for Diagnostic & Statistical Manual of Mental Disorders, 5th | 40.40 units on a scale STANDARD_DEVIATION 16.44 | 47.46 units on a scale STANDARD_DEVIATION 14.63 | 45.70 units on a scale STANDARD_DEVIATION 15.72 |
| Race/Ethnicity, Customized Black/African American | 20 Participants | 13 Participants | 33 Participants |
| Race/Ethnicity, Customized Hispanic | 43 Participants | 23 Participants | 66 Participants |
| Race/Ethnicity, Customized Mixed identity | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Native American/Pacific Islander | 8 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Female | 90 Participants | 66 Participants | 156 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Substance use, 5-panel test | 9 Participants | 2 Participants | 11 Participants |
| Substance Use - Texas Christian University Drug Screen | 8.68 units on a scale STANDARD_DEVIATION 2.4 | 8.98 units on a scale STANDARD_DEVIATION 2.45 | 8.81 units on a scale STANDARD_DEVIATION 2.42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 66 |
| other Total, other adverse events | 0 / 90 | 0 / 66 |
| serious Total, serious adverse events | 0 / 90 | 0 / 66 |
Outcome results
Primary
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.
Time frame: Immediately post-intervention & 6-month follow-up
Population: The total number analyzed for Time 2 (immediate post-intervention follow-up) was 125. The total number analyzed for Time 3 was 86. The numbers differ due to attrition over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Time 2 (immediate post-intervention) | 26.93 score on a scale | Standard Deviation 18.2 |
| Modified Mindfulness-based Stress Reduction | Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Time 3 (6-month follow-up) | 24.46 score on a scale | Standard Deviation 15.38 |
| Health Promotion Attention Control | Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Time 2 (immediate post-intervention) | 30.75 score on a scale | Standard Deviation 16.62 |
| Health Promotion Attention Control | Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Time 3 (6-month follow-up) | 28.33 score on a scale | Standard Deviation 14.88 |
p-value: 0.84695% CI: [-6.46, 5.29]Mixed Models Analysis
Secondary
Cortisol Reactivity
Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics). Higher scores indicate more change in cortisol.
Time frame: Immediately post-intervention & 6-month follow-up
Population: The total number analyzed for Time 2 (immediate post-intervention follow-up) was 118. The total number analyzed for Time 3 was 76. The numbers differ due to attrition and missing data over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Cortisol Reactivity | Time 2 (immediate post-intervention) | -2.10 Micrograms per deciliter (µg/dL) | Standard Deviation 10.45 |
| Modified Mindfulness-based Stress Reduction | Cortisol Reactivity | Time 3 (6-month follow-up) | -2.45 Micrograms per deciliter (µg/dL) | Standard Deviation 10.53 |
| Health Promotion Attention Control | Cortisol Reactivity | Time 2 (immediate post-intervention) | -0.70 Micrograms per deciliter (µg/dL) | Standard Deviation 3.98 |
| Health Promotion Attention Control | Cortisol Reactivity | Time 3 (6-month follow-up) | -1.76 Micrograms per deciliter (µg/dL) | Standard Deviation 9.11 |
Comparison: A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.p-value: 0.73795% CI: [-3.57, 2.53]Mixed Models Analysis
Secondary
C-Reactive Protein (CRP)
Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. Higher scores indicate higher concentration of CRP.
Time frame: Immediately post-intervention & 6-month follow-up
Population: The total number analyzed for Time 2 (immediate post-intervention follow-up) was 121. The total number analyzed for Time 3 was 80. The numbers differ due to attrition and missing data over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | C-Reactive Protein (CRP) | Time 2 (immediate post-intervention) | 2395.32 Milligrams per deciliter (mg/dL) | Standard Deviation 3542.12 |
| Modified Mindfulness-based Stress Reduction | C-Reactive Protein (CRP) | Time 3 (6-month follow-up) | 3950.69 Milligrams per deciliter (mg/dL) | Standard Deviation 7617.19 |
| Health Promotion Attention Control | C-Reactive Protein (CRP) | Time 2 (immediate post-intervention) | 1725.80 Milligrams per deciliter (mg/dL) | Standard Deviation 3266.13 |
| Health Promotion Attention Control | C-Reactive Protein (CRP) | Time 3 (6-month follow-up) | 1248.06 Milligrams per deciliter (mg/dL) | Standard Deviation 1390.65 |
Comparison: A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.p-value: 0.02495% CI: [-4471.46, -312.49]Mixed Models Analysis
Secondary
Depression
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.
Time frame: Immediately post-intervention & 6-month follow-up
Population: The total number analyzed for Time 2 (immediate post-intervention follow-up) was 126. The total number analyzed for Time 3 was 86. The numbers differ due to attrition over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Depression | Time 2 (immediate post-intervention) | 13.19 score on a scale | Standard Deviation 6.52 |
| Modified Mindfulness-based Stress Reduction | Depression | Time 3 (6-month follow-up) | 11.98 score on a scale | Standard Deviation 5.06 |
| Health Promotion Attention Control | Depression | Time 2 (immediate post-intervention) | 17.98 score on a scale | Standard Deviation 8.24 |
| Health Promotion Attention Control | Depression | Time 3 (6-month follow-up) | 16.97 score on a scale | Standard Deviation 6.66 |
Comparison: A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.p-value: 0.13995% CI: [-4.36, 0.6]Mixed Models Analysis
Secondary
Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup
Count of participants with positive substance use from baseline to follow-up using 5-panel FDA-approved urine test cup.
Time frame: Immediately post-intervention & 6-month follow-up
Population: The total number analyzed for Time 2 (immediate post-intervention follow-up) was 118. The total number analyzed for Time 3 was 79. The numbers differ due to attrition and missing data over time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Time 2 (immediate post-intervention); total number positive for any substance | 4 Participants |
| Modified Mindfulness-based Stress Reduction | Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Time 3 (6-month follow-up); total number positive for any substance | 2 Participants |
| Health Promotion Attention Control | Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Time 2 (immediate post-intervention); total number positive for any substance | 3 Participants |
| Health Promotion Attention Control | Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Time 3 (6-month follow-up); total number positive for any substance | 3 Participants |
Comparison: A multilevel model was constructed using a logit distribution. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was included as a fixed-effect. An independent covariance pattern was specified. Final models were random-intercept only.p-value: 0.16695% CI: [-4.26, 0.73]Mixed Models Analysis
Secondary
Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5)
Change in continues measure of self-report substance use from baseline to follow-ups using the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5). The possible range for the score is 1-11. Participants respond to a series of 13 possible no (0) or yes (1) questions, with two questions counting for a maximum score of 1 each. Higher scores indicate more severe substance use.
Time frame: Immediately post-intervention & 6-month follow-up
Population: The total number analyzed for Time 2 (immediate post-intervention follow-up) was 119. The total number analyzed for Time 3 was 86. The numbers differ due to attrition and missing data over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5) | Time 2 (immediate post-intervention) | 0.68 score on a scale | Standard Deviation 1.79 |
| Modified Mindfulness-based Stress Reduction | Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5) | Time 3 (6-month follow-up) | 1.24 score on a scale | Standard Deviation 2.43 |
| Health Promotion Attention Control | Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5) | Time 2 (immediate post-intervention) | 1.71 score on a scale | Standard Deviation 2.56 |
| Health Promotion Attention Control | Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5) | Time 3 (6-month follow-up) | 1.28 score on a scale | Standard Deviation 3.05 |
Comparison: A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.p-value: 0.22295% CI: [-1.21, 0.97]Mixed Models Analysis