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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03922581
Recruitment Status Suspended (Enrollment is temporarily suspended due to COVID-19)
First Posted April 22, 2019
Last update posted May 4, 2020
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).
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.
|Experimental: Mindfulness-Based Cognitive Therapy
Participants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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)
- 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
United States, Georgia
Grady Health System
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Abigail Lott, PhD Emory University