CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Mindfulness-Based Cognitive Therapybehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03922581
NCT03922581N/ACompleted

Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals

Emory University·interventional·Posted Apr 22, 2019·Updated Sep 19, 2024

In Brief

A clinical study evaluating Mindfulness-Based Cognitive Therapy for Post Traumatic Stress Disorder and Major Depressive Disorder. Completed, enrolled 80 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 22, 2019
Enrollment StartSep 14, 2018
Primary CompletionAug 18, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.2 years ago

Interventions

Mindfulness-Based Cognitive Therapybehavioral

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.