Primary-Care Based Mindfulness Intervention

• ClinicalTrials.gov Identifier: NCT03922581
• Recruitment Status: Completed
• First Posted: April 22, 2019
• Last Update Posted: August 22, 2023
• Sponsor: Emory University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Abigail Lott, Emory University

Tracking Information

• First Submitted Date: April 18, 2019
• First Posted Date: April 22, 2019
• Last Update Posted Date: August 22, 2023
• Actual Study Start Date: September 14, 2018
• Actual Primary Completion Date: August 18, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2019)

• Retention rate [ Time Frame: Baseline through Follow-up (1 month after the end of the 8-week intervention) ]
  Retention rates will be 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 ]
  Feasibility and acceptability will be 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 24 where higher values indicate greater satisfaction.
• Perceived Barriers to Psychological Treatment (PBPT) Scale Score [ Time Frame: Week 8 ]
  Barriers to treatment will be 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.
• Change in Difficulties in Emotion Regulation Scale (DERS) Score [ Time Frame: Baseline, Weeks 3, 5, 7, 8, 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.
• Post-group Follow-up Questionnaire [ Time Frame: Week 8 ]
  Participants randomized to the MBCT intervention will complete an open-ended, follow-up questionnaire designed to assess feelings and changes experienced from participation in the intervention. The 10 questions include "how did you feel about the group?" and "what barriers came up for you in participating in the group?". Responses are in text form rather than on a pre-set scale.
• Change in skin conductance [ Time Frame: Baseline, Week 8, Follow-up (3 months after the end of the intervention) ]
  Skin conductance (SC) response will be measured 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 will be 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 18, 2019)

• Change in Primary Care PTSD Screen (PC-PTSD) Determination [ Time Frame: Baseline, Week 8, Follow-up (1 month after the end of the intervention) ]
  The Primary Care PTSD Screen (PC-PTSD) is a 4-item screen designed for use in primary care will 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 4 questions.
• Change in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Baseline, Week 8, Follow-up (1 month after the end of the intervention) ]
  The Patient Health Questionnaire-9 (PHQ-9) will assess for presence of depressive symptoms and serve as 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.
• Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score [ Time Frame: Baseline, Week 8 ]
  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.
• Change in Beck Depression Inventory-II (BDI-II) Score [ Time Frame: Baseline, Week 8 ]
  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.
• Change in Clinician Administered PTSD Scale PTSD Determination [ Time Frame: Baseline, Week 8 ]
  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.
• Change in Mini International Neuropsychiatric Interview (MINI) MDD Determination [ Time Frame: Baseline, Week 8 ]
  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.
• Change in Five Facet Mindfulness Questionnaire Score [ Time Frame: Baseline, Week 8, Follow-up (1 month after the end of the intervention) ]
  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.
• Change in Self Compassion Scale, Short Form Score [ Time Frame: Baseline, Week 8, Follow-up (1 month after the end of the intervention) ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Primary-Care Based Mindfulness Intervention
• Official Title: Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals
• Brief 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. 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:

Staff members conducting the Clinician Administered PTSD Scale and the Mini-International Neuropsychiatric Interview will be blind to study arm assignment.

Primary Purpose: Treatment

Condition

• Post Traumatic Stress Disorder
• Major Depressive Disorder

Intervention

Behavioral: 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 will return one month after the intervention has ended for a follow-up assessment.

Study Arms

• Experimental: Mindfulness-Based Cognitive Therapy
  Participants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
  Intervention: Behavioral: Mindfulness-Based Cognitive Therapy
• No Intervention: Wait-list Control Group
  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.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2019): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 18, 2023
• Actual Primary Completion Date: August 18, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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 ≥ 10)

Exclusion Criteria:

• presence of intellectual disability, bipolar, or psychotic disorder
• presence of current substance use disorder (past 1 month; see cut off scores in psychological measures below)
• active suicidality

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03922581
• Other Study ID Numbers: IRB00104519; K23AT009713 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All individual participant data collected that underlie the research results reported in the article will be available for sharing, after deidentification.
• Supporting Materials: Study Protocol
• Time Frame: Specific data from analyses submitted for publication will be available 6 months following publication with no end date.
• Access Criteria: 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.

• Current Responsible Party: Abigail Lott, Emory University
• Original Responsible Party: Same as current
• Current Study Sponsor: Emory University
• Original Study Sponsor: Same as current
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Abigail Lott, PhD; Emory University

• PRS Account: Emory University
• Verification Date: August 2023