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Sham for Adolescents With Early Life Stress (A-MindREaL Trial)

N/A
Waitlist Available
Led By Namik Kirlic, PhD
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (average: 2 weeks)
Awards & highlights

A-MindREaL Trial Summary

This trial will study whether a certain type of mindfulness training can help alleviate some of the effects of early life adversity in youth.

Eligible Conditions
  • Adolescents With Early Life Stress

A-MindREaL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (average: 2 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (average: 2 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI
Secondary outcome measures
Perceived Stress Scale (PSS) scores
Positive and Negative Affect Schedule for Children (PANAS-C) scores
State Mindfulness Scale (SMS) scores

A-MindREaL Trial Design

2Treatment groups
Active Control
Group I: ShamActive Control1 Intervention
Participants will receive an artificial neurofeedback signal during mindfulness practice in the MRI
Group II: Augmented Mindfulness Training (AMT)Active Control1 Intervention
Participants will receive real-time neurofeedback from the PCC during mindfulness practice in the MRI

Find a Location

Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,677 Total Patients Enrolled
Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,262 Total Patients Enrolled
1 Trials studying Adolescents With Early Life Stress
40 Patients Enrolled for Adolescents With Early Life Stress
Namik Kirlic, PhDPrincipal InvestigatorLaureate Institute for Brain Research
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Adolescents With Early Life Stress
40 Patients Enrolled for Adolescents With Early Life Stress

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this clinical trial open to participate?

"To qualify for this trial, adolescents aged 13 to 17 with a history of early life stress must apply. Ultimately, the research team is looking to recruit 120 participants in total."

Answered by AI

Are there openings for participation in this research project?

"Clinicaltrials.gov notes that this trial is no longer accepting participants, having been first posted on the 1st of August 2019 and last updated on 19th of August 2022. On a positive note though, there are 107 other studies actively recruiting patients now."

Answered by AI

Is the age threshold for recruitment in this trial over 25 years?

"As stipulated in the study requirements, any patient between 13 and 17 can take part."

Answered by AI
Recent research and studies
Cognitive, Affective, & Behavioral NeuroscienceJournal
Self-regulation of the Posterior Cingulate Cortex with Real-time Fmri Neurofeedback Augmented Mindfulness Training in Healthy Adolescents: A Nonrandomized Feasibility Study
Kirlic, Namik, Zsofia P. Cohen, Aki Tsuchiyagaito, Masaya Misaki, Timothy J. McDermott, Robin L. Aupperle, Jennifer L. Stewart, Manpreet K. Singh, Martin P. Paulus, and Jerzy Bodurka. 2022. “Self-regulation of the Posterior Cingulate Cortex with Real-time Fmri Neurofeedback Augmented Mindfulness Training in Healthy Adolescents: A Nonrandomized Feasibility Study”. Cognitive, Affective, & Behavioral Neuroscience. Springer Science and Business Media LLC. doi:10.3758/s13415-022-00991-4.
Cognitive, Affective, & Behavioral NeuroscienceJournal
Self-regulation of the Posterior Cingulate Cortex with Real-time Fmri Neurofeedback Augmented Mindfulness Training in Healthy Adolescents: A Nonrandomized Feasibility Study
Kirlic, Namik, Zsofia P. Cohen, Aki Tsuchiyagaito, Masaya Misaki, Timothy J. McDermott, Robin L. Aupperle, Jennifer L. Stewart, Manpreet K. Singh, Martin P. Paulus, and Jerzy Bodurka. 2022. “Self-regulation of the Posterior Cingulate Cortex with Real-time Fmri Neurofeedback Augmented Mindfulness Training in Healthy Adolescents: A Nonrandomized Feasibility Study”. Cognitive, Affective, & Behavioral Neuroscience. Springer Science and Business Media LLC. doi:10.3758/s13415-022-00991-4.
clinicaltrials.govStudy
Augmented Mindfulness Training for Resilience in Early Life
2019. "Augmented Mindfulness Training for Resilience in Early Life". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04053582.
~15 spots leftby Apr 2025
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