Clinical trial NCT03922581: Primary-Care Based Mindfulness Intervention
Official title: Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Major Depressive Disorder
Keywords: Anxiety disorders
Behavioral intervention
Psychology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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 ≥ 5)

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants Retained in Study
timeFrame: Baseline through Follow-up (1 month after the end of the 8-week intervention)
measure: Client Satisfaction Questionnaire (CSQ) Score
timeFrame: Week 8 (post-intervention assessment)
measure: Perceived Barriers to Psychological Treatment (PBPT) Scale Score
timeFrame: Week 8 (post-intervention assessment)
measure: Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: Baseline, Weeks 3, 5, 7, 8 (post-intervention assessment), and Follow-up (1 month after the end of the intervention)
measure: Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire
timeFrame: Week 8 (post-intervention assessment)
measure: Skin Conductance Among In-Person Intervention Participants
timeFrame: Baseline, Week 8 (post-intervention assessment)
Secondary outcomes:
measure: Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination
timeFrame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
measure: Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
timeFrame: Baseline, Week 8 (post-intervention assessment)
measure: Beck Depression Inventory-II (BDI-II) Score
timeFrame: Baseline, Week 8 (post-intervention assessment)
measure: Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale
timeFrame: Baseline, Week 8 (post-intervention assessment)
measure: Mini International Neuropsychiatric Interview (MINI) MDD Determination
timeFrame: Baseline, Week 8 (post-intervention assessment)
measure: Five Facet Mindfulness Questionnaire Score
timeFrame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
measure: Self Compassion Scale, Short Form Score
timeFrame: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Abigail Lott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.