Primary-Care Based Mindfulness Intervention
Condition: Post Traumatic Stress Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): Mindfulness-Based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): 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.
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)
Primary purpose: Treatment
Keywords: Anxiety disorders; Behavioral intervention; Psychology