N/A
N=80
Primary-Care Based Mindfulness Intervention
Post Traumatic Stress Disorder · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03922581 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Retained in Study — 22; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-Based Cognitive Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Retained in Study |
22; 26 | — |
| PRIMARY Client Satisfaction Questionnaire (CSQ) Score |
30.36 | — |
| PRIMARY Perceived Barriers to Psychological Treatment (PBPT) Scale Score |
48.23; 53.70 | — |
| PRIMARY Difficulties in Emotion Regulation Scale (DERS) Score |
78.05; 83.77; 77.08; 73.46; 83.03; 73.17 | — |
| PRIMARY Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire |
15; 11; 0; 2; 0; 0 | — |
| PRIMARY Skin Conductance Among In-Person Intervention Participants |
1.39; 1.29; 1.07; 0.62 | — |
| SECONDARY Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination |
43; 36; 16; 21; 10; 15 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) Score |
17.35; 18.67; 13.30; 13.64; 12.47; 14.22 | — |
| SECONDARY PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score |
49.12; 54.86; 34.91; 37.41 | — |
| SECONDARY Beck Depression Inventory-II (BDI-II) Score |
33.80; 36.39; 24.94; 25.16 | — |
| SECONDARY Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale |
32; 21; 9; 21 | — |
| SECONDARY Mini International Neuropsychiatric Interview (MINI) MDD Determination |
26; 23; 12; 16 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Score |
119.81; 122.39; 124.35; 122.46; 130.14; 121.15 | — |
| SECONDARY Self Compassion Scale, Short Form Score |
31.44; 32.45; 35.42; 33.68; 34.65; 34.04 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03922581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.