Augmented Mindfulness Training for Resilience in Early Life
- Conditions
- Adolescents With Early Life Stress
- Interventions
- Behavioral: AMTBehavioral: Sham
- Registration Number
- NCT04053582
- Lead Sponsor
- Laureate Institute for Brain Research, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Augmented Mindfulness Training (AMT) AMT Participants will receive real-time neurofeedback from the PCC during mindfulness practice in the MRI Sham Sham Participants will receive an artificial neurofeedback signal during mindfulness practice in the MRI
- Primary Outcome Measures
Name Time Method Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI 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 Outcome Measures
Name Time Method State Mindfulness Scale (SMS) scores Through study completion (average: 2 weeks) The SMS is a 21-item measure rated on a 5-point Likert scale (not at all - very well). Items may be summed or averaged, with greater scores indicating greater levels of state mindfulness. SMS scores will evidence a greater increase from pre- to post-training and 1-week follow-up in the AMT relative to the Sham group.
Positive and Negative Affect Schedule for Children (PANAS-C) scores Through study completion (average: 2 weeks) The PANAS-C assesses domains of positive and negative affect on a 5-point Likert scale (not much or not at all - a lot) with 30 items. Scores for each domain are summed, with greater scores indicating greater levels of its respective affective domain. PANAS-C scores will evidence a greater change from pre- to post-training and 1-week follow-up in AMT relative to the Sham group.
Perceived Stress Scale (PSS) scores Through study completion (average: 2 weeks) The PSS is a 10 item measure on a 5-point Likert scale (never - very often), with 4 items reverse scaled. Items are summed, with greater scores indicating greater levels of perceived stress. PSS scores will evidence a greater decrease from pre- to post-training and 1-week follow-up in AMT relative to the Sham group.
Trial Locations
- Locations (1)
Laureate Institute for Brain Research
🇺🇸Tulsa, Oklahoma, United States