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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT009713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abigail Lott, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41347209 | Derived | 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. | |
| 38990692 | Derived | Lathan 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. |
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All individual participant data collected that underlie the research results reported in the article will be available for sharing, after deidentification.
Specific data from analyses submitted for publication will be available 6 months following publication with no end date.
Data will be shared with researchers who provide a methodologically sound proposal, for individual participant report meta-analysis. Specific data sharing requests should be directed to adpower@emory.edu. To gain access, requestors will need to sign a data access agreement. Data will be available indefinitely at a link to be provided.
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Study enrollment was suspended in March 2020 due to the Coronavirus 2019 (COVID-19) pandemic. Enrollment reopened in September 2020 with a virtual intervention, rather than an in-person intervention.
Participants were recruited from Grady Health System in Atlanta, Georgia, USA. Participant enrollment began September 14, 2018 and the final study assessment occurred on August 18, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Cognitive Therapy | Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. Mindfulness-Based Cognitive Therapy: 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 return one month after the intervention has ended for a follow-up assessment. |
| FG001 | Wait-list Control Group | Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In-Person Mindfulness-Based Cognitive Therapy | Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. Participants enrolled between September 2018 and March 2020 received at least some of the intervention in-person. |
| BG001 | In-Person Wait-list Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline through Follow-up (1 month after the end of the 8-week intervention) |
|
Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-Based Cognitive Therapy | Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood symptom increase | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abigail Lott, PhD | Emory University | 404-712-0159 | abigail.lott@emoryhealthcare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2022 | May 20, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2022 | Jun 21, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003865 | Depressive Disorder, Major |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
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Not provided
| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Participants will be randomized with block stratified randomization (in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups.
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Staff members conducting the Clinician Administered PTSD Scale and the Mini-International Neuropsychiatric Interview will be blind to study arm assignment.
|
| 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. | 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. | Baseline, Week 8 (post-intervention assessment) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention) |
| 36265048 | Derived | Powers 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. |
| Withdrawal by Subject |
|
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. Participants enrolled between September 2018 and March 2020 received at least some of the intervention in-person. |
| BG002 | Virtual Mindfulness-Based Cognitive Therapy | Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. Participants enrolled after recruitment re-opened in September 2020 received the intervention virtually. |
| BG003 | Virtual Wait-list Control Group | Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. Participants enrolled after recruitment re-opened in September 2020 received the intervention virtually. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Wait-list Control Group |
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. |
|
|
| Primary | 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. | This analysis includes participants in the MBCT study arm who completed the Post-Intervention Assessment (25 participants) and who completed this questionnaire. Three participants had missing CSQ data due to an error where the questionnaire was not administered at this time-point. | Posted | Mean | Standard Deviation | score on a scale | Week 8 (post-intervention assessment) |
|
|
|
| Primary | 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. | This analysis includes participants who completed the post-intervention assessment. Two participants in the Wait-list Control Group do not have data for the PBPT due to an error in not administering the instrument. | Posted | Mean | Standard Deviation | score on a scale | Week 8 (post-intervention assessment) |
|
|
|
| Primary | 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. | One participant in MBCT requested all data removed so baseline score was unavailable; 1 participant in MBCT and 2 participants in Wait-list Control (WLC) had multiple missing self-report measures at baseline due to interviewer error. Missing data at Weeks 3, 5, and 7 were related to a participant not present at group or unable to be reached for the assessment component. The DERS was not administered to the WLC group at Weeks 3 and 7. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 3, 5, 7, 8 (post-intervention assessment), and Follow-up (1 month after the end of the intervention) |
|
|
|
| Primary | 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. | This analysis includes participants receiving the MBCT intervention, either in-person or virtually, who attended the post-intervention assessment and responded to this question. | Posted | Count of Participants | Participants | Week 8 (post-intervention assessment) |
|
|
|
| Primary | 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. | 8 MBCT and 8 WLC participants do not have usable baseline data due to a missing measurement, noise/error in output, iPad malfunction, or request for data removal. 2 MBCT participants and 7 WLC participants do not have Week 8 data because it was unusable due to noise/error in output. 3 MBCT participants and 1 WLC participants missed SC data collection at Week 8 due to onset of the COVID-19 pandemic and 2 WLC participants were missing SC data collection at Week 8 due to iPad malfunction. | Posted | Mean | Standard Deviation | µSiemens (µS) | Baseline, Week 8 (post-intervention assessment) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery. | Posted | Count of Participants | Participants | Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Baseline data for 1 MBCT participant and 1 WLC participant was missing due to interviewer error. Additional missing data at Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 (post-intervention assessment) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Baseline data for 3 MBCT participants were also missing due to interviewer error. Additional missing data at Week 8 were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 (post-intervention assessment) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. | Posted | Count of Participants | Participants | Baseline, Week 8 (post-intervention assessment) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. | Posted | Count of Participants | Participants | Baseline, Week 8 (post-intervention assessment) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Baseline, and Week 8 were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention) |
|
|
|
| Secondary | 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. | 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Baseline, Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention) |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 11 |
| 44 |
| EG001 | Wait-list Control Group | Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. | 0 | 36 | 0 | 36 | 3 | 36 |
| Anxiety symptom increase | Psychiatric disorders | Non-systematic Assessment |
|
| Coronavirus Disease 2019 (COVID-19) | Infections and infestations | Non-systematic Assessment |
|
| Work related physical injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Prolonged menstrual bleeding related to birth control pill | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Stitches on toe | Surgical and medical procedures | Non-systematic Assessment |
|
| Lump in armpit | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Worsening arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Worsening chronic pain | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Eye dryness/irritation | Eye disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Chronic liver dysfunction diagnosis | Hepatobiliary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D019964 | Mood Disorders |
| D004191 |
| Behavioral Disciplines and Activities |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Week 3 |
|
|
| Week 5 |
|
|
| Week 7 |
|
|
| Week 8 |
|
|
| Follow-up one month after end of intervention |
|
|
| Negative change |
|
| Week 8 |
|
|
| Week 8 |
|
|
| Follow-up |
|
|
| Week 8 |
|
|
| Follow-up |
|
|
| Week 8 |
|
|
| Week 8 |
|
|
| Week 8 |
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| Week 8 |
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| Week 8 |
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| Follow-up |
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| Week 8 |
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| Follow-up |
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