Adolescents With Early Life StressA-MindREaLNCT04053582
Augmented Mindfulness Training for Resilience in Early Life
A study testing AMT in people with Adolescents With Early Life Stress, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents With Early Life Stress
- What is being tested?
- AMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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):
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
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.
Read the 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 known about interventions that may prevent them and the optimal time to do so. Not only is ELA associated with earlier onset and greater severity and comorbidity of depression, anxiety, and substance abuse, these individuals also evidence significantly poorer responses to psychological and pharmacological interventions when treated for these conditions. Consequently, there is a dire need to develop preventive interventions that target individuals with ELA exposure. The first step in this process is to establish malleability of neural mechanisms disrupted by ELA exposure to acute interventions. We use augmented mindfulness training, that is, a standard mindfulness training combined with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) to influence and increase the plasticity of brain areas affected by ELA, in turn affecting state changes in symptoms in youth with ELA exposure. These fMRI tasks are designed to engage the PCC and mindfulness practice.
Over the course of three years, 120 eligible youth with early life adversity or healthy controls will be recruited into the study. All healthy controls will receive AMT, and ELA-exposed youth will be randomly assigned to AMT, consisting of real-time fMRI with neurofeedback during mindfulness practice, or Sham, consisting of artificially calculated neurofeedback signals during mindfulness practice. Adolescents will complete self-report measures to assess state affective symptoms before and after receiving mindfulness training and scanning, and again one week later.
- Conditions
- Adolescents With Early Life Stress
- Being tested
- AMT, Sham
- Keywords
- Early life adversity, Adolescents, Mindfulness, Neurobiology, Stress and resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMTBehavioural
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).
ShamBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Augmented Mindfulness Training (AMT) | Active comparator | Participants will receive real-time neurofeedback from the PCC during mindfulness practice in the MRI Receives: Behavioral: AMT |
| Sham | Active comparator | Participants will receive an artificial neurofeedback signal during mindfulness practice in the MRI Receives: Behavioral: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (average: 2 weeks)
Secondary outcomes (3)
State Mindfulness Scale (SMS) scores
The SMS is a 21-item measure rated on a 5-point Likert scale (not at all - very well). Items may be summed or averaged, with greater scores indicating greater levels of state mindfulness. SMS scores will evidence a greater increase from pre- to post-training and 1-week follow-up in the AMT relative to the Sham group.
Measured: Through study completion (average: 2 weeks)
Perceived Stress Scale (PSS) scores
The PSS is a 10 item measure on a 5-point Likert scale (never - very often), with 4 items reverse scaled. Items are summed, with greater scores indicating greater levels of perceived stress. PSS scores will evidence a greater decrease from pre- to post-training and 1-week follow-up in AMT relative to the Sham group.
Measured: Through study completion (average: 2 weeks)
Positive and Negative Affect Schedule for Children (PANAS-C) scores
The PANAS-C assesses domains of positive and negative affect on a 5-point Likert scale (not much or not at all - a lot) with 30 items. Scores for each domain are summed, with greater scores indicating greater levels of its respective affective domain. PANAS-C scores will evidence a greater change from pre- to post-training and 1-week follow-up in AMT relative to the Sham group.
Measured: Through study completion (average: 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescents With Early Life StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ELA-exposed youth are randomly assigned to receive augmented mindfulness training with real-time neurofeedback or a sham condition.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Namik Kirlic, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053582
- Sponsor's protocol ID
- LIBR # 2019-003-01
- Other IDs
- 5P20GM121312
- Acronym
- A-MindREaL
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39539491Kirlic 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.
PubMed 35292905
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Mindfulness Training for Resilience in Early Life
- ClinicalTrials.gov ID
- NCT04053582
- Acronym / sponsor ID
- A-MindREaL / LIBR # 2019-003-01
- Conditions
- Adolescents With Early Life Stress
- Keywords
- Early life adversity, Adolescents, Mindfulness, Neurobiology, Stress and resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 known about interventions that may prevent them and the optimal time to do so. Not only is ELA associated with earlier onset and greater severity and comorbidity of depression, anxiety, and substance abuse, these individuals also evidence significantly poorer responses to psychological and pharmacological interventions when treated for these conditions. Consequently, there is a dire need to develop preventive interventions that target individuals with ELA exposure. The first step in this process is to establish malleability of neural mechanisms disrupted by ELA exposure to acute interventions. We use augmented mindfulness training, that is, a standard mindfulness training combined with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) to influence and increase the plasticity of brain areas affected by ELA, in turn affecting state changes in symptoms in youth with ELA exposure. These fMRI tasks are designed to engage the PCC and mindfulness practice.
Over the course of three years, 120 eligible youth with early life adversity or healthy controls will be recruited into the study. All healthy controls will receive AMT, and ELA-exposed youth will be randomly assigned to AMT, consisting of real-time fMRI with neurofeedback during mindfulness practice, or Sham, consisting of artificially calculated neurofeedback signals during mindfulness practice. Adolescents will complete self-report measures to assess state affective symptoms before and after receiving mindfulness training and scanning, and again one week later.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ELA-exposed youth are randomly assigned to receive augmented mindfulness training with real-time neurofeedback or a sham condition.
| Arm | Type | Receives |
|---|---|---|
| Augmented Mindfulness Training (AMT) | Active comparator | Behavioral: AMTParticipants will receive real-time neurofeedback from the PCC during mindfulness practice in the MRI |
| Sham | Active comparator | Behavioral: ShamParticipants will receive an artificial neurofeedback signal during mindfulness practice in the MRI |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Age 13.00 - 17.99 years at time of baseline assessment
- Able to validly and safely complete baseline assessments
- All genders
- All races
- Age 13.00 - 17.99 years at time of baseline assessment
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMTThe 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). | Behavioural | Augmented Mindfulness Training (AMT) |
| ShamThe 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). | Behavioural | Sham |
Primary outcome
Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI
Time frame: Through study completion (average: 2 weeks)
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.
3 secondary outcomes
State Mindfulness Scale (SMS) scores
Time frame: Through study completion (average: 2 weeks)
Perceived Stress Scale (PSS) scores
Time frame: Through study completion (average: 2 weeks)
Positive and Negative Affect Schedule for Children (PANAS-C) scores
Time frame: Through study completion (average: 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39539491Cosgrove 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.
- Derived from this study: PubMed 35292905Kirlic 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namik Kirlic, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMT in people with Adolescents With Early Life Stress, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI (time frame: Through study completion (average: 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.