Primary-Care Based Mindfulness Intervention

Emory University

Status: Completed

Conditions: Major Depressive Disorder; Post Traumatic Stress Disorder

Treatments: Behavioral: Mindfulness-Based Cognitive Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03922581

IRB00104519

K23AT009713 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy

Wait-list Control Group

No Intervention group

Description:

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.