Stress Disorders, Post-TraumaticNCT04605198
Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
A study testing Modified Mindfulness-based Stress Reduction and Health Promotion Wellness Classes in people with Stress Disorders, Post-Traumatic and Depressive Symptoms, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depressive Symptoms, Hydrocortisone
- What is being tested?
- Modified Mindfulness-based Stress Reduction and Health Promotion Wellness Classes
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2020to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not speaking English
- judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North County Serenity House
Escondido, California, 92026
Prototypes Women's Center
Pomona, California, 91767
About this study
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:
Read more
- 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.
- 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.
- Being tested
- Modified Mindfulness-based Stress Reduction, Health Promotion Wellness Classes
- Keywords
- PTSD, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Mindfulness-based Stress ReductionBehavioural
Also called modified 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 Wellness ClassesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified Mindfulness-based Stress Reduction | Experimental | Not described Receives: Behavioral: Modified Mindfulness-based Stress Reduction |
| Health Promotion Attention Control | Active comparator | Not described Receives: Behavioral: Health Promotion Wellness Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention & 6-month follow-up
Secondary outcomes (5)
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.
Measured: 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)
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.
Measured: Immediately post-intervention & 6-month follow-up
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.
Measured: Immediately post-intervention & 6-month follow-up
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.
Measured: Immediately post-intervention & 6-month follow-up
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.
Measured: Immediately post-intervention & 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start6 Oct 2020
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Dana Rose Garfin, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605198
- Sponsor's protocol ID
- 2019-5607
- Other IDs
- 5K01MD013910
- Status last verified
- Feb 2025
- First submitted
- 21 Oct 2020
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
- ClinicalTrials.gov ID
- NCT04605198
- Acronym / sponsor ID
- 2019-5607
- Keywords
- PTSD, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified Mindfulness-based Stress Reduction | Experimental | Behavioral: Modified Mindfulness-based Stress Reduction |
| Health Promotion Attention Control | Active comparator | Behavioral: Health Promotion Wellness Classes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- not speaking English
- judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Mindfulness-based Stress ReductionAlso: modified MBSRParticipants 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. | Behavioural | Modified Mindfulness-based Stress Reduction |
| Health Promotion Wellness ClassesSessions 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. | Behavioural | Health Promotion Attention Control |
Primary outcome
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 frame: 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.
5 secondary outcomes
Depression
Time frame: 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)
Time frame: Immediately post-intervention & 6-month follow-up
Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup
Time frame: Immediately post-intervention & 6-month follow-up
Cortisol Reactivity
Time frame: Immediately post-intervention & 6-month follow-up
C-Reactive Protein (CRP)
Time frame: Immediately post-intervention & 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Mindfulness-based Stress Reduction and Health Promotion Wellness Classes in people with Stress Disorders, Post-Traumatic and Depressive Symptoms, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: Immediately post-intervention & 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.