Primary-Care Based Mindfulness Intervention

NCT03922581 | Completed Results DMC

• 2 other identifiers: IRB00104519K23AT009713
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder; Major Depressive Disorder

Keywords

Anxiety disorders; Behavioral intervention; Psychology

Outcome Measures

Primary Outcomes (6)

• 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.

  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)

Secondary Outcomes (8)

• Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination

  Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)

• Patient Health Questionnaire-9 (PHQ-9) Score

  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

  Baseline, Week 8 (post-intervention assessment)

• Beck Depression Inventory-II (BDI-II) Score

  Baseline, Week 8 (post-intervention assessment)

• Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale

  Baseline, Week 8 (post-intervention assessment)

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

Participants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.

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.

Interventions

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.

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• presence of intellectual disability, bipolar, or psychotic disorder
• presence of current substance use disorder (past 1 month)
• active suicidality

Sponsors & Collaborators

• Emory University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Related Publications (3)

• 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.

  PMID: 41347209 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.

  PMID: 38990692 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.

  PMID: 36265048 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Anxiety Disorders

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Abigail Lott, PhD
• Organization: Emory University

abigail.lott@emoryhealthcare.org

404-712-0159

Study Officials

• Abigail Lott, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff members conducting the Clinician Administered PTSD Scale and the Mini-International Neuropsychiatric Interview will be blind to study arm assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized with block stratified randomization (in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 22, 2019
• Study Start: September 14, 2018
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)