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Augmented Mindfulness Training for Resilience in Early Life

NCT04053582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Adolescents With Early Life Stress

Interventions

BEHAVIORAL

AMT

The session will be done on an individual basis. AMT group will receive neurofeedback training from the PCC while focusing on the physical sensations of the breath. The session will last one hour, including 3 neurofeedback runs during which subjects will undergo three conditions across three consecutive blocks: Rest (30s), Describe (view an adjective and decide whether the word describes them; 20s), and Focus on the Breath with neurofeedback (70s).

BEHAVIORAL

Sham

The session will be done on an individual basis. Sham group will receive artificial neurofeedback while focusing on the physical sensations of the breath. The session will last one hour, including 3 sham neurofeedback runs during which subjects will undergo three conditions across three consecutive blocks: Rest (30s), Describe (view an adjective and decide whether the word describes them; 20s), and Focus on the Breath with artificial neurofeedback (70s).

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Laureate Institute for Brain Research, Inc.

    lead OTHER

Principal Investigators

  • Namik Kirlic, PhD · Laureate Institute for Brain Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-08-01
Completion
2023-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04053582 on ClinicalTrials.gov