Status:
COMPLETED
Augmented Mindfulness Training for Resilience in Early Life
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Adolescents With Early Life Stress
Eligibility:
All Genders
13-17 years
Phase:
NA
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 fi...
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 kn...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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).
- Current use of medications with major effects on brain function or blood flow (e.g., antipsychotics, acne medications). For ELA-exposed participants, the use of one (1) medication (e.g., SSRI's, ADHD medications) will not be exclusionary permitting that participant has been on a stable dosage for at least 6 weeks prior to study enrollment.
- 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
- Current use of medications with major effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers, ADHD medications, SSRIs, and acne medications).
Exclusion
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04053582
Start Date
August 1 2019
End Date
August 1 2023
Last Update
November 18 2023
Active Locations (1)
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1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136