Augmented Mindfulness Training for Resilience in Early Life
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adolescents With Early Life Stress
- Sponsor
- Laureate Institute for Brain Research, Inc.
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This project aims to determine whether neurofeedback augmented mindfulness intervention increases the plasticity in brain areas affected by exposure to early life adversity in youth. The study will first establish the augmented mindfulness training protocol targeting the posterior cingulate cortex (PCC) with real-time fMRI neurofeedback for use with healthy control and ELA-exposed youth. Next, in addition to ongoing data collection with healthy controls, ELA-exposed youth will be randomly assigned to either complete the neurofeedback augmented mindfulness training (AMT) or sham condition protocol. Effect of augmented mindfulness training on state measures of mindfulness, perceived stress, and affect will be examined.
Detailed Description
Early life adversity (ELA) is a major public health crisis that results in significant disruptions in neurobiological processes and long-term psychiatric and health consequences, yet very little is known about interventions that may prevent them and the optimal time to do so. Not only is ELA associated with earlier onset and greater severity and comorbidity of depression, anxiety, and substance abuse, these individuals also evidence significantly poorer responses to psychological and pharmacological interventions when treated for these conditions. Consequently, there is a dire need to develop preventive interventions that target individuals with ELA exposure. The first step in this process is to establish malleability of neural mechanisms disrupted by ELA exposure to acute interventions. We use augmented mindfulness training, that is, a standard mindfulness training combined with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) to influence and increase the plasticity of brain areas affected by ELA, in turn affecting state changes in symptoms in youth with ELA exposure. These fMRI tasks are designed to engage the PCC and mindfulness practice. Over the course of three years, 120 eligible youth with early life adversity or healthy controls will be recruited into the study. All healthy controls will receive AMT, and ELA-exposed youth will be randomly assigned to AMT, consisting of real-time fMRI with neurofeedback during mindfulness practice, or Sham, consisting of artificially calculated neurofeedback signals during mindfulness practice. Adolescents will complete self-report measures to assess state affective symptoms before and after receiving mindfulness training and scanning, and again one week later.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI
Time Frame: Through study completion (average: 2 weeks)
Percent signal change in the PCC for Focus - Describe condition contrast will be lower in the AMT relative to the Sham group during mindfulness practice.
Secondary Outcomes
- State Mindfulness Scale (SMS) scores(Through study completion (average: 2 weeks))
- Positive and Negative Affect Schedule for Children (PANAS-C) scores(Through study completion (average: 2 weeks))
- Perceived Stress Scale (PSS) scores(Through study completion (average: 2 weeks))