Trial Outcomes & Findings for Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women (NCT NCT04605198)
NCT ID: NCT04605198
Last Updated: 2025-03-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
Immediately post-intervention & 6-month follow-up
Results posted on
2025-03-11
Participant Flow
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.
Participant milestones
| Measure |
Modified Mindfulness-based Stress Reduction (MBSR)
Modified Mindfulness-based Stress Reduction (MBSR): 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 (HP 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.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
66
|
|
Overall Study
COMPLETED
|
71
|
47
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some data was contaminated or did not have adequate volume for analyses, thus 144 rather than 156 observations were available.
Baseline characteristics by cohort
| Measure |
Modified Mindfulness-based Stress Reduction
n=90 Participants
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.
|
Health Promotion Attention Control
n=66 Participants
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.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.52 Years
STANDARD_DEVIATION 9.79 • n=90 Participants
|
35.18 Years
STANDARD_DEVIATION 11.23 • n=66 Participants
|
35.38 Years
STANDARD_DEVIATION 10.39 • n=156 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=90 Participants
|
66 Participants
n=66 Participants
|
156 Participants
n=156 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=90 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=156 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=90 Participants
|
29 Participants
n=66 Participants
|
79 Participants
n=156 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=90 Participants
|
37 Participants
n=66 Participants
|
77 Participants
n=156 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=90 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=156 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=90 Participants
|
16 Participants
n=66 Participants
|
33 Participants
n=156 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
20 Participants
n=90 Participants
|
13 Participants
n=66 Participants
|
33 Participants
n=156 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
43 Participants
n=90 Participants
|
23 Participants
n=66 Participants
|
66 Participants
n=156 Participants
|
|
Race/Ethnicity, Customized
Mixed identity
|
2 Participants
n=90 Participants
|
4 Participants
n=66 Participants
|
6 Participants
n=156 Participants
|
|
Race/Ethnicity, Customized
Native American/Pacific Islander
|
8 Participants
n=90 Participants
|
10 Participants
n=66 Participants
|
18 Participants
n=156 Participants
|
|
Posttraumatic Stress Disorder Checklist for Diagnostic & Statistical Manual of Mental Disorders, 5th
|
40.40 units on a scale
STANDARD_DEVIATION 16.44 • n=90 Participants
|
47.46 units on a scale
STANDARD_DEVIATION 14.63 • n=66 Participants
|
45.70 units on a scale
STANDARD_DEVIATION 15.72 • n=156 Participants
|
|
Mean PROMIS Depression
|
17.72 units on a scale
STANDARD_DEVIATION 8.28 • n=90 Participants
|
20.42 units on a scale
STANDARD_DEVIATION 8.80 • n=66 Participants
|
18.87 units on a scale
STANDARD_DEVIATION 8.58 • n=156 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety
|
20.88 units on a scale
STANDARD_DEVIATION 6.67 • n=90 Participants
|
22.12 units on a scale
STANDARD_DEVIATION 7.04 • n=66 Participants
|
21.40 units on a scale
STANDARD_DEVIATION 6.84 • n=156 Participants
|
|
Substance Use - Texas Christian University Drug Screen
|
8.68 units on a scale
STANDARD_DEVIATION 2.40 • n=90 Participants
|
8.98 units on a scale
STANDARD_DEVIATION 2.45 • n=66 Participants
|
8.81 units on a scale
STANDARD_DEVIATION 2.42 • n=156 Participants
|
|
Substance use, 5-panel test
|
9 Participants
n=90 Participants
|
2 Participants
n=66 Participants
|
11 Participants
n=156 Participants
|
|
C-Reactive Protein (CRP)
|
4639.62 Milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 9332.93 • n=90 Participants
|
1330.49 Milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 2160.09 • n=66 Participants
|
3239.60 Milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 7393.32 • n=156 Participants
|
|
Cortisol reactivity
|
-.912 Milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 2.32 • n=84 Participants • Some data was contaminated or did not have adequate volume for analyses, thus 144 rather than 156 observations were available.
|
-.617 Milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 2.41 • n=60 Participants • Some data was contaminated or did not have adequate volume for analyses, thus 144 rather than 156 observations were available.
|
-.789 Milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 2.35 • n=144 Participants • Some data was contaminated or did not have adequate volume for analyses, thus 144 rather than 156 observations were available.
|
PRIMARY outcome
Timeframe: Immediately post-intervention & 6-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Modified Mindfulness-based Stress Reduction
n=73 Participants
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.
|
Health Promotion Attention Control
n=52 Participants
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.
|
|---|---|---|
|
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 18.20
|
30.75 score on a scale
Standard Deviation 16.62
|
|
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
|
28.33 score on a scale
Standard Deviation 14.88
|
SECONDARY outcome
Timeframe: Immediately post-intervention & 6-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Modified Mindfulness-based Stress Reduction
n=73 Participants
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.
|
Health Promotion Attention Control
n=53 Participants
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.
|
|---|---|---|
|
Depression
Time 2 (immediate post-intervention)
|
13.19 score on a scale
Standard Deviation 6.52
|
17.98 score on a scale
Standard Deviation 8.24
|
|
Depression
Time 3 (6-month follow-up)
|
11.98 score on a scale
Standard Deviation 5.06
|
16.97 score on a scale
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: Immediately post-intervention & 6-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Modified Mindfulness-based Stress Reduction
n=90 Participants
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.
|
Health Promotion Attention Control
n=66 Participants
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.
|
|---|---|---|
|
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
|
1.71 score on a scale
Standard Deviation 2.56
|
|
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
|
1.28 score on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Immediately post-intervention & 6-month follow-upPopulation: 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.
Count of participants with positive substance use from baseline to follow-up using 5-panel FDA-approved urine test cup.
Outcome measures
| Measure |
Modified Mindfulness-based Stress Reduction
n=71 Participants
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.
|
Health Promotion Attention Control
n=47 Participants
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.
|
|---|---|---|
|
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
|
3 Participants
|
|
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
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediately post-intervention & 6-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Modified Mindfulness-based Stress Reduction
n=71 Participants
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.
|
Health Promotion Attention Control
n=47 Participants
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.
|
|---|---|---|
|
Cortisol Reactivity
Time 2 (immediate post-intervention)
|
-2.10 Micrograms per deciliter (µg/dL)
Standard Deviation 10.45
|
-0.70 Micrograms per deciliter (µg/dL)
Standard Deviation 3.98
|
|
Cortisol Reactivity
Time 3 (6-month follow-up)
|
-2.45 Micrograms per deciliter (µg/dL)
Standard Deviation 10.53
|
-1.76 Micrograms per deciliter (µg/dL)
Standard Deviation 9.11
|
SECONDARY outcome
Timeframe: Immediately post-intervention & 6-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Modified Mindfulness-based Stress Reduction
n=72 Participants
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.
|
Health Promotion Attention Control
n=49 Participants
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.
|
|---|---|---|
|
C-Reactive Protein (CRP)
Time 2 (immediate post-intervention)
|
2395.32 Milligrams per deciliter (mg/dL)
Standard Deviation 3542.12
|
1725.80 Milligrams per deciliter (mg/dL)
Standard Deviation 3266.13
|
|
C-Reactive Protein (CRP)
Time 3 (6-month follow-up)
|
3950.69 Milligrams per deciliter (mg/dL)
Standard Deviation 7617.19
|
1248.06 Milligrams per deciliter (mg/dL)
Standard Deviation 1390.65
|
Adverse Events
Modified Mindfulness-based Stress Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Promotion Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Dana Rose Garfin, Associate Professor
University of California, Los Angeles
Phone: 415-407-9498
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place