Post Traumatic Stress DisorderNCT03922581
Primary-Care Based Mindfulness Intervention
A study testing Mindfulness-Based Cognitive Therapy in people with Post Traumatic Stress Disorder and Major Depressive Disorder, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to pilot a primary-care based mindfulness intervention for chronically traumatized African Americans screening positive for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) in primary care clinics within an urban public hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Major Depressive Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 18 Aug 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to provide informed consent
- willingness to participate in study
- self-identity as African American
- history of childhood and/or adult trauma exposure (3 total criterion A traumas)
- positive PTSD screen (PC-PTSD ≥ 3)
- positive MDD screen (PHQ-9 ≥ 5)
Who cannot join
- presence of intellectual disability, bipolar, or psychotic disorder
- presence of current substance use disorder (past 1 month)
- active suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals
The purpose of this study is to pilot a primary-care based mindfulness intervention for chronically traumatized African Americans screening positive for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) in primary care clinics within an urban public hospital. The study will utilize a randomized controlled trial (RCT) design along with a multi-method psychological and physiological assessment approach to establish the feasibility and acceptability of a mindfulness-based cognitive therapy (MBCT) intervention for primary care versus wait-list control in African Americans with chronic trauma exposure and comorbid PTSD and MDD. Preliminary mechanisms of action associated with MBCT including emotion dysregulation and autonomic function will be evaluated. The data collection and 8-session group intervention will take place in primary care clinics within an urban public hospital serving primarily low-income, minority individuals (>80% African American).
Read the detailed description
There is significant public health burden of chronic trauma exposure in low income, predominantly ethnic minority, urban communities, which is reflected in the extraordinarily high levels of trauma-related psychiatric disorders, particularly PTSD and MDD. Despite this, limited access to behavioral health treatment and significant barriers to treatment engagement and success remain and integrating mind-body approaches in medical settings could be a critical next step in treating chronically traumatized individuals in these urban settings. This study will utilize a randomized controlled trial design along with a multi-method assessment approach to ascertain the feasibility, acceptability, and preliminary mechanisms of action and outcomes of mindfulness-based cognitive therapy versus wait-list control in 80 African Americans with chronic trauma exposure and comorbid PTSD and MDD symptoms.
Participants will be randomized to an 8-session (90 minutes each) group intervention or wait-list control. The researchers will examine the retention and follow-up rates, participants' report of acceptability and interest in the intervention, and examine barriers to treatment engagement through self-report measures and exit interviews. This study will also investigate preliminary mechanisms of action and outcomes of the mindfulness intervention in targeting emotion regulation and autonomic processes by measuring self-report of emotion dysregulation using the Difficulties in Emotion Regulation Scale and autonomic arousal to trauma cues using eSense technology to assess skin conductance during administration of Standardized Trauma Interview. Latent growth modeling will assess relative changes in emotion dysregulation and autonomic function over time through intervention and 1 month follow-up.
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- Anxiety disorders, Behavioral intervention, Psychology
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
The intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants will return one month after the intervention has ended for a follow-up assessment.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Participants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
| Wait-list Control Group | No intervention | Participants randomized to the wait-list control study arm will be administered the study assessments while not receiving active treatment. Participants will be given the opportunity to participate in the MBCT intervention following completion of the study assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained in Study
Retention rates were assessed using session attendance. Previous mindfulness-based stress reduction (MBSR) interventions among low-income minority populations have yielded completion rates of 53-80%. Based on 80% completion rates of MBSR in primary care and 75% completion rates of MBCT both in combat vet samples and the anticipated improved accessibility through primary care, it is expected that subjects in the intervention group will evidence at least 75% retention and follow-up rates.
Measured: Baseline through Follow-up (1 month after the end of the 8-week intervention)
Client Satisfaction Questionnaire (CSQ) Score
Feasibility and acceptability of the Mindfulness-Based Cognitive Therapy intervention was assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item questionnaire asking respondents to rate the quality of care they received on a scale from 1 to 4 where 1 = poor and 4 = excellent. Total raw scores range from 8 to 32 where higher values indicate greater satisfaction.
Measured: Week 8 (post-intervention assessment)
Perceived Barriers to Psychological Treatment (PBPT) Scale Score
Barriers to treatment was assessed using the Perceived Barriers to Psychological Treatment (PBPT) scale. The PBPT is a 25-item scale asking respondents about factors that interfere with attending weekly therapy. Items are rated on a 5-point scale where 1 = impossible to attend and 5 = not a problem. Total raw scores range from 25 to 125 where higher scores indicate low barriers regarding attending psychotherapy.
Measured: Week 8 (post-intervention assessment)
Difficulties in Emotion Regulation Scale (DERS) Score
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item instrument assessing emotion dysregulation and includes six subscales (non-acceptance of emotions, difficulty with goal-directed behavior in the presence of negative emotions, difficulty controlling impulses in the presence of negative emotions, lack of awareness of emotions, limited use of effective emotion regulation strategies, and lack of understanding of emotions). Responses are scaled from 1 (almost never) to 5 (almost always). Total raw scores range from 36 to 180; certain items are reverse scored so that higher scores indicate increased difficulty with emotion regulation.
Measured: Baseline, Weeks 3, 5, 7, 8 (post-intervention assessment), and Follow-up (1 month after the end of the intervention)
Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire
Participants randomized to the MBCT intervention completed an open-ended, follow-up questionnaire designed to assess feelings and changes experienced from participation in the intervention. Participants were asked "Have you noticed any changes in how you experience emotions or handle stressful situations?". Responses were given in text form rather than on a pre-set scale, and were then categorized as positive change, no change, or negative change.
Measured: Week 8 (post-intervention assessment)
Skin Conductance Among In-Person Intervention Participants
Skin conductance (SC) response was measured among participants receiving the in-person intervention using a mobile SC device, eSense (Mindfield Biosystems). Continuous recording of SC is measured with electrodes on hands and data is transmitted through the eSense app. Using the PhenX Toolkit protocol, a two minute baseline measure of SC will be obtained and then SC levels were measured during administration of the Standardized Trauma Interview immediately following to determine physiological reactivity to trauma stimuli. SC response is calculated by subtracting SC level at the end of baseline recording (average of last 30 seconds) from the maximum SC level value during the trauma interview.
Measured: Baseline, Week 8 (post-intervention assessment)
Secondary outcomes (8)
Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination
The Primary Care PTSD Screen (PC-PTSD) is a 5-item screen designed for use in primary care used to assess for presence of PTSD symptoms and serve as PTSD screener. Respondents answer "yes" or "no" to each question and an individual is considered to have PTSD if they respond with "yes" to at least 3 of the 5 questions.
Measured: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Patient Health Questionnaire-9 (PHQ-9) Score
The Patient Health Questionnaire-9 (PHQ-9) will assess for presence of depressive symptoms and serve as a major depressive disorder (MDD) screening tool. The PHQ-9 is a 9-item tool that asks respondents to indicate how frequently they have felt symptoms of depression on a scale of 0 to 3 where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27, where higher scores indicate worse depression.
Measured: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
The PCL-5 is a 20-item questionnaire asking respondents to report how much they have been bothered by problems in the past month on a scale of 0 (not at all) to 4 (extremely). Total scores range from 0 to 80 where higher scores indicate increased difficulty with responses to stressful experiences.
Measured: Baseline, Week 8 (post-intervention assessment)
Beck Depression Inventory-II (BDI-II) Score
The BDI-II is a 21-item instrument asking respondents to indicate how much they are bothered by negative feelings. Responses are on a scale of 0 to 3 where 0 = the problematic feeling is not present and 3 = the feeling is very strong. Total scores range from 0 to 63, where high scores indicate worse problems with negative feelings.
Measured: Baseline, Week 8 (post-intervention assessment)
Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale
The Clinician Administered PTSD Scale is a semi-structured interview used for diagnosing PTSD. The number of participants diagnosed with PTSD pre- and post-intervention will be compared between study arms.
Measured: Baseline, Week 8 (post-intervention assessment)
Mini International Neuropsychiatric Interview (MINI) MDD Determination
The Mini International Neuropsychiatric Interview (MINI) is a semi-structured interview used for diagnosing MDD. The number of participants diagnosed with MDD pre- and post-intervention will be compared between study arms.
Measured: Baseline, Week 8 (post-intervention assessment)
Five Facet Mindfulness Questionnaire Score
The Five Facet Mindfulness Questionnaire is a 39-item instrument assessing mindfulness, and includes five facets (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Participants respond to each item on a scale of 1 to 5 where 1 = the statement is never or very rarely true for them and 5 = the statement is very often or always true. Total raw scores range from 39 to 195; certain items are reverse scored so that higher scores indicate increased mindfulness.
Measured: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Self Compassion Scale, Short Form Score
The Self Compassion Scale is a 12-item instrument assessing how respondents typically act towards themselves during difficult times. Items are answered on a scale of 1 to 5 where 1 = almost never and 5 = almost always. Total scores range from 12 to 60; certain items are reversed scored so that higher scores indicate increased self compassion.
Measured: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start14 Sep 2018
- Primary completion18 Aug 2023
- Study completion18 Aug 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 randomized with block stratified randomization (in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Abigail Lott, Emory University
- Investigators
- Abigail Lott, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922581
- Sponsor's protocol ID
- IRB00104519
- Other IDs
- K23AT009713
- Status last verified
- Sep 2024
- First submitted
- 18 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected that underlie the research results reported in the article will be available for sharing, after deidentification.
Publications
Powers A, Lipschutz R, Lathan EC, Mekawi Y, Dixon HD, Bradley B, Kaslow NJ, Nugent NR. Improved Mindfulness Following Mindfulness-Based Cognitive Therapy: Results from a Pilot Randomized Controlled Trial with Trauma-Exposed Black Adults. Mindfulness (N Y). 2025;16(11):3163-3176. doi: 10.1007/s12671-025-02693-7. Epub 2025 Oct 27.
PubMed 41347209Lathan EC, McAfee EE, Spivey BN, Garcia V, Kaslow N, Powers A. Risk for posttraumatic stress disorder symptoms by trauma type: The role of self-compassion. Psychol Trauma. 2025 Mar;17(3):603-611. doi: 10.1037/tra0001707. Epub 2024 Jul 11.
PubMed 38990692Powers A, Lathan EC, Dixon HD, Mekawi Y, Hinrichs R, Carter S, Bradley B, Kaslow NJ. Primary care-based mindfulness intervention for posttraumatic stress disorder and depression symptoms among Black adults: A pilot feasibility and acceptability randomized controlled trial. Psychol Trauma. 2023 Jul;15(5):858-867. doi: 10.1037/tra0001390. Epub 2022 Oct 20.
PubMed 36265048
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals
- ClinicalTrials.gov ID
- NCT03922581
- Acronym / sponsor ID
- IRB00104519
- Keywords
- Anxiety disorders, Behavioral intervention, Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot a primary-care based mindfulness intervention for chronically traumatized African Americans screening positive for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) in primary care clinics within an urban public hospital. The study will utilize a randomized controlled trial (RCT) design along with a multi-method psychological and physiological assessment approach to establish the feasibility and acceptability of a mindfulness-based cognitive therapy (MBCT) intervention for primary care versus wait-list control in African Americans with chronic trauma exposure and comorbid PTSD and MDD. Preliminary mechanisms of action associated with MBCT including emotion dysregulation and autonomic function will be evaluated. The data collection and 8-session group intervention will take place in primary care clinics within an urban public hospital serving primarily low-income, minority individuals (>80% African American).
Detailed description
There is significant public health burden of chronic trauma exposure in low income, predominantly ethnic minority, urban communities, which is reflected in the extraordinarily high levels of trauma-related psychiatric disorders, particularly PTSD and MDD. Despite this, limited access to behavioral health treatment and significant barriers to treatment engagement and success remain and integrating mind-body approaches in medical settings could be a critical next step in treating chronically traumatized individuals in these urban settings. This study will utilize a randomized controlled trial design along with a multi-method assessment approach to ascertain the feasibility, acceptability, and preliminary mechanisms of action and outcomes of mindfulness-based cognitive therapy versus wait-list control in 80 African Americans with chronic trauma exposure and comorbid PTSD and MDD symptoms.
Participants will be randomized to an 8-session (90 minutes each) group intervention or wait-list control. The researchers will examine the retention and follow-up rates, participants' report of acceptability and interest in the intervention, and examine barriers to treatment engagement through self-report measures and exit interviews. This study will also investigate preliminary mechanisms of action and outcomes of the mindfulness intervention in targeting emotion regulation and autonomic processes by measuring self-report of emotion dysregulation using the Difficulties in Emotion Regulation Scale and autonomic arousal to trauma cues using eSense technology to assess skin conductance during administration of Standardized Trauma Interview. Latent growth modeling will assess relative changes in emotion dysregulation and autonomic function over time through intervention and 1 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized with block stratified randomization (in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyParticipants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. |
| Wait-list Control Group | No intervention | –Participants randomized to the wait-list control study arm will be administered the study assessments while not receiving active treatment. Participants will be given the opportunity to participate in the MBCT intervention following completion of the study assessments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ability to provide informed consent
- willingness to participate in study
- self-identity as African American
- history of childhood and/or adult trauma exposure (3 total criterion A traumas)
- positive PTSD screen (PC-PTSD ≥ 3)
Key exclusion criteria (3 listed)
- presence of intellectual disability, bipolar, or psychotic disorder
- presence of current substance use disorder (past 1 month)
- active suicidality
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 |
|---|---|---|
| Mindfulness-Based Cognitive TherapyThe intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants will return one month after the intervention has ended for a follow-up assessment. | Behavioural | Mindfulness-Based Cognitive Therapy |
Primary outcome
Number of Participants Retained in Study
Time frame: Baseline through Follow-up (1 month after the end of the 8-week intervention)
Retention rates were assessed using session attendance. Previous mindfulness-based stress reduction (MBSR) interventions among low-income minority populations have yielded completion rates of 53-80%. Based on 80% completion rates of MBSR in primary care and 75% completion rates of MBCT both in combat vet samples and the anticipated improved accessibility through primary care, it is expected that subjects in the intervention group will evidence at least 75% retention and follow-up rates.
Client Satisfaction Questionnaire (CSQ) Score
Time frame: Week 8 (post-intervention assessment)
Feasibility and acceptability of the Mindfulness-Based Cognitive Therapy intervention was assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item questionnaire asking respondents to rate the quality of care they received on a scale from 1 to 4 where 1 = poor and 4 = excellent. Total raw scores range from 8 to 32 where higher values indicate greater satisfaction.
Perceived Barriers to Psychological Treatment (PBPT) Scale Score
Time frame: Week 8 (post-intervention assessment)
Barriers to treatment was assessed using the Perceived Barriers to Psychological Treatment (PBPT) scale. The PBPT is a 25-item scale asking respondents about factors that interfere with attending weekly therapy. Items are rated on a 5-point scale where 1 = impossible to attend and 5 = not a problem. Total raw scores range from 25 to 125 where higher scores indicate low barriers regarding attending psychotherapy.
Difficulties in Emotion Regulation Scale (DERS) Score
Time frame: Baseline, Weeks 3, 5, 7, 8 (post-intervention assessment), and Follow-up (1 month after the end of the intervention)
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item instrument assessing emotion dysregulation and includes six subscales (non-acceptance of emotions, difficulty with goal-directed behavior in the presence of negative emotions, difficulty controlling impulses in the presence of negative emotions, lack of awareness of emotions, limited use of effective emotion regulation strategies, and lack of understanding of emotions). Responses are scaled from 1 (almost never) to 5 (almost always). Total raw scores range from 36 to 180; certain items are reverse scored so that higher scores indicate increased difficulty with emotion regulation.
Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire
Time frame: Week 8 (post-intervention assessment)
Participants randomized to the MBCT intervention completed an open-ended, follow-up questionnaire designed to assess feelings and changes experienced from participation in the intervention. Participants were asked "Have you noticed any changes in how you experience emotions or handle stressful situations?". Responses were given in text form rather than on a pre-set scale, and were then categorized as positive change, no change, or negative change.
Skin Conductance Among In-Person Intervention Participants
Time frame: Baseline, Week 8 (post-intervention assessment)
Skin conductance (SC) response was measured among participants receiving the in-person intervention using a mobile SC device, eSense (Mindfield Biosystems). Continuous recording of SC is measured with electrodes on hands and data is transmitted through the eSense app. Using the PhenX Toolkit protocol, a two minute baseline measure of SC will be obtained and then SC levels were measured during administration of the Standardized Trauma Interview immediately following to determine physiological reactivity to trauma stimuli. SC response is calculated by subtracting SC level at the end of baseline recording (average of last 30 seconds) from the maximum SC level value during the trauma interview.
8 secondary outcomes
Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination
Time frame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
Time frame: Baseline, Week 8 (post-intervention assessment)
Beck Depression Inventory-II (BDI-II) Score
Time frame: Baseline, Week 8 (post-intervention assessment)
Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale
Time frame: Baseline, Week 8 (post-intervention assessment)
Mini International Neuropsychiatric Interview (MINI) MDD Determination
Time frame: Baseline, Week 8 (post-intervention assessment)
Five Facet Mindfulness Questionnaire Score
Time frame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Self Compassion Scale, Short Form Score
Time frame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41347209Powers A, Lipschutz R, Lathan EC, Mekawi Y, Dixon HD, Bradley B, Kaslow NJ, Nugent NR. Improved Mindfulness Following Mindfulness-Based Cognitive Therapy: Results from a Pilot Randomized Controlled Trial with Trauma-Exposed Black Adults. Mindfulness (N Y). 2025;16(11):3163-3176. doi: 10.1007/s12671-025-02693-7. Epub 2025 Oct 27.
- Derived from this study: PubMed 38990692Lathan EC, McAfee EE, Spivey BN, Garcia V, Kaslow N, Powers A. Risk for posttraumatic stress disorder symptoms by trauma type: The role of self-compassion. Psychol Trauma. 2025 Mar;17(3):603-611. doi: 10.1037/tra0001707. Epub 2024 Jul 11.
- Derived from this study: PubMed 36265048Powers A, Lathan EC, Dixon HD, Mekawi Y, Hinrichs R, Carter S, Bradley B, Kaslow NJ. Primary care-based mindfulness intervention for posttraumatic stress disorder and depression symptoms among Black adults: A pilot feasibility and acceptability randomized controlled trial. Psychol Trauma. 2023 Jul;15(5):858-867. doi: 10.1037/tra0001390. Epub 2022 Oct 20.
- Individual participant dataSharing planned: Yes. All individual participant data collected that underlie the research results reported in the article will be available for sharing, after deidentification.
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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.
Abigail Lott, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy in people with Post Traumatic Stress Disorder and Major Depressive Disorder, run by Emory University at 1 site 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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 19 Sep 2024). 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?
Number of Participants Retained in Study (time frame: Baseline through Follow-up (1 month after the end of the 8-week intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922581, which also lists 3 linked publications.
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 19 Sep 2024.