Augmented Mindfulness Training for Resilience in Early Life

NCT04053582 | Completed DMC

• 2 other identifiers: LIBR # 2019-003-015P20GM121312
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescents With Early Life Stress

Keywords

Early life adversity; Adolescents; Mindfulness; Neurobiology; Stress and resilience

Outcome Measures

Primary Outcomes (1)

• Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI

  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.

  Through study completion (average: 2 weeks)

Secondary Outcomes (3)

• State Mindfulness Scale (SMS) scores

  Through study completion (average: 2 weeks)

• Perceived Stress Scale (PSS) scores

  Through study completion (average: 2 weeks)

• Positive and Negative Affect Schedule for Children (PANAS-C) scores

  Through study completion (average: 2 weeks)

Study Arms (2)

Augmented Mindfulness Training (AMT)

ACTIVE COMPARATOR

Participants will receive real-time neurofeedback from the PCC during mindfulness practice in the MRI

Behavioral: AMT

Sham

ACTIVE COMPARATOR

Participants will receive an artificial neurofeedback signal during mindfulness practice in the MRI

Behavioral: Sham

Interventions

AMT BEHAVIORAL

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).

Augmented Mindfulness Training (AMT)

Sham BEHAVIORAL

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).

Sham

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy controls (n=48):
• Age 13.00 - 17.99 years at time of baseline assessment
• Able to validly and safely complete baseline assessments
• All genders
• All races
• ELA-exposed participants (n=72):
• Age 13.00 - 17.99 years at time of baseline assessment
• Able to validly and safely complete baseline assessments
• All genders
• All races
• Endorsing 4 or more types of maltreatments on the Maltreatment and Abuse Chronology and Exposure (MACE) scale, OR meeting the cutoff score on 2 or more of the 5 subscales on the Childhood Trauma Questionnaire (CTQ):
• Sexual abuse ≥ 8 Physical abuse ≥ 8 Emotional abuse ≥ 10 Physical neglect ≥ 8 Emotional neglect ≥ 15
• Moderate levels of depression or anxiety (one standard deviation above the mean) as measured by the NIH PROMIS measures

You may not qualify if:

• All participants:
• No biological parent or legal guardian identified to give permission for minor to participate
• History of neurological disorders including seizure disorder, cerebral palsy, or other conditions requiring neurological or medical care, being managed for migraines (e.g., daily prophylactic medication, seeing a neurologist for migraines), or a diagnosis of Developmental Delay, including severe learning disorder, mental retardation, autism spectrum disorders, pervasive developmental disorder, or other conditions requiring repeated and persistent specialized education.
• Current psychotic disorder, bipolar disorder, obsessive-compulsive and related disorders, substance use disorder, conduct problems (i.e., conduct or oppositional defiant disorder).
• MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy
• Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia) or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires).
• Severe claustrophobia
• Not fluent in English
• Weight less than 100 lbs.
• Non-correctable vision, hearing or sensorimotor impairments, as protocol elements may not be valid
• Youth planning to move to an area not within reasonable traveling distance of LIBR; knowledge at baseline that treatment completion/follow-up will not be possible
• Youth appears to be high/intoxicated, or withdrawing from the effects of alcohol or drugs at time of enrollment
• Healthy controls:
• History of or current psychiatric illness
• Endorsing 2 or more types of maltreatments on the Maltreatment and Abuse Chronology and Exposure (MACE) scale, or meeting the cutoff score on one or more of the subscales on the Childhood Trauma Questionnaire (CTQ) Sexual abuse ≥ 8 Physical abuse ≥ 8 Emotional abuse ≥ 10 Physical neglect ≥ 8 Emotional neglect ≥ 15

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (2)

• Cosgrove KT, Tsuchiyagaito A, Cohen ZP, Cochran G, Yu X, Misaki M, Aupperle RL, Singh MK, Paulus MP, Kirlic N. Augmenting mindfulness training through neurofeedback: a pilot study of the pre-post changes on resting-state functional connectivity in typically developing adolescents. Front Neurosci. 2024 Oct 30;18:1397234. doi: 10.3389/fnins.2024.1397234. eCollection 2024.

  PMID: 39539491 DERIVED

• Kirlic N, Cohen ZP, Tsuchiyagaito A, Misaki M, McDermott TJ, Aupperle RL, Stewart JL, Singh MK, Paulus MP, Bodurka J. Self-regulation of the posterior cingulate cortex with real-time fMRI neurofeedback augmented mindfulness training in healthy adolescents: A nonrandomized feasibility study. Cogn Affect Behav Neurosci. 2022 Aug;22(4):849-867. doi: 10.3758/s13415-022-00991-4. Epub 2022 Mar 15.

  PMID: 35292905 DERIVED

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Namik Kirlic, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ELA-exposed youth are randomly assigned to receive augmented mindfulness training with real-time neurofeedback or a sham condition.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)