Augmented Mindfulness Training for Resilience in Early Life
Completed · Not applicable · Has a placebo group
Conditions studied: Adolescents With Early Life Stress
In brief
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.
Key facts
- Study ID
- NCT04053582
- Run by
- Laureate Institute for Brain Research, Inc.
- People needed
- 83
- Starts
- 2019-08-01
- Expected to finish
- 2023-08-01
- Last updated by the study team
- 2023-11-18
Who can join
Age: 13 and older, up to 17. Sex: any. Healthy volunteers: accepted.
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).
- 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).
Where it is running
- Laureate Institute for Brain Research — Tulsa, Oklahoma, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.