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Mindfulness for Resilience in Early Life (MindREaL)

Primary Purpose

Adolescent With Early Life Stress, Resilience

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness

About this trial

This is an interventional prevention trial for Adolescent With Early Life Stress focused on measuring Early life stress, Adolescent, Mindfulness, Neurobiological, Stress, Resilience

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 13.00 to 15.99 years at time of baseline assessment
Able to validly and safely complete baseline assessments
All genders
All races
Eligibility as a subject with early life stress will be determined by:
Scoring 4 or greater on Adverse Childhood Experiences (ACE) scale, with at least two experiences having occurred prior to age 10.

Exclusion Criteria:

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, 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, or conduct disorder.
Current active suicidal ideation.
Current use of medications with major effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); ADHD medications and SSRIs, that have been stable for at least 6 weeks, are not exclusionary since their use is associated with conditions that confer risk for monitored disorders that emerge in adolescence, and assessment of these individuals will provide useful data to the scientific community. Youth on ADHD medications and SSRIs will not be asked to go off their medications.
Not fluent in English
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.
Youth / parent who are unable or unwilling to provide biological samples (i.e., blood draws or saliva collection).
Female youth who are pregnant
Youth who are currently in unsafe environments (e.g., currently living with an abusive parent)

Sites / Locations

Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mindfulness

Control

Arm Description

Mindfulness: Eight sessions, twice per week over four weeks. Surveys administered prior to each session.

Treatment as usual (i.e., pharmacotherapy, psychotherapy, etc.) for the four week duration with twice weekly surveys administered.

Outcomes

Primary Outcome Measures

Cortisol Reactivity

Change in level of cortisol in saliva following a social stress test. Subjects completed the Trier Social Stress Test for Children (TSST-C) at baseline and follow-up. The TSST-C consists of public speaking and serial subtraction components in front of two research confederates. The test takes approximately 20 minutes to complete. Salivary cortisol was collected 20 minutes prior to TSST-C, and 20 minutes following the end of the TSST-C, such that the TSST-C task with data collection spanned approximately one hour.

Immune System Activity

Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood

Secondary Outcome Measures

Mood and Feelings Questionnaire

Measure Description: We used the Mood and Feelings Questionnaire - Short Form (MFQ-sf) to characterize symptoms of anxiety and depression. The MFQ-sf is a 13-item questionnaire with a simple sum score for the entire scale. Minimum score = 0, maximum score = 26. Scores of 8 or more indicate moderate depression. Codings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all. Higher scores indicate greater symptoms of anxiety/depression, while lower scores indicate less anxiety/depression.

Full Information

NCT ID

NCT03633903

First Posted

August 13, 2018

Last Updated

July 27, 2021

Sponsor

Laureate Institute for Brain Research, Inc.

Collaborators

Oklahoma State University

1. Study Identification

Unique Protocol Identification Number

NCT03633903

Brief Title

Mindfulness for Resilience in Early Life

Acronym

MindREaL

Official Title

Mindfulness for Resilience in Early Life

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

July 12, 2018 (Actual)

Primary Completion Date

March 7, 2019 (Actual)

Study Completion Date

March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laureate Institute for Brain Research, Inc.

Collaborators

Oklahoma State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Early life stress (ELS) is associated with a number of psychiatric and medical conditions later in life, thought to be caused by subsequent disruptions in biological processes involved in regulation of stress responses. Given that these alterations have long-lasting effects, there is a great need for effective preventative interventions. The long-term goal of this project is to identify early interventions that may most powerfully mitigate risk for psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus on interventions that can be widely and effectively implemented, have the potential for long-lasting benefits, and can effectively engage targeted neurobiological processes and networks. The specific aims of the present study are to 1) examine how ELS impacts biological processes associated with regulation of stress, and 2) identify how MBI impacts affective symptoms and biological processes dysregulated by ELS. This study supports the efforts to reduce the effects of early adversity in children by testing an impact of an effective psychological intervention on disrupted biological processes caused by early adversity. Successful achievement of the proposed aims will contribute to a) the knowledge base needed to reduce the effects of trauma and stress in children and families and b) the development of easily implemented and disseminated preventative interventions. The proposed study will utilize a multi-method design to examine the effect of mindfulness on biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents age 13 to 15. Adolescents will first complete self-report measures of childhood adverse experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned to either an eight session mindfulness-based stress reduction intervention for teens or no treatment. Pre- and post-intervention assessment will include (a) self-report measures of symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and gene expression, and (c) a stress task with saliva cortisol collected before and after this task.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adolescent With Early Life Stress, Resilience

Keywords

Early life stress, Adolescent, Mindfulness, Neurobiological, Stress, Resilience

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Adolescents are randomly assigned to either a mindfulness intervention or no intervention.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness

Arm Type

Active Comparator

Arm Description

Mindfulness: Eight sessions, twice per week over four weeks. Surveys administered prior to each session.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Treatment as usual (i.e., pharmacotherapy, psychotherapy, etc.) for the four week duration with twice weekly surveys administered.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness

Intervention Description

Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience

Primary Outcome Measure Information:

Title

Cortisol Reactivity

Description

Time Frame

Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Title

Immune System Activity

Description

Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood

Time Frame

Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Secondary Outcome Measure Information:

Title

Mood and Feelings Questionnaire

Description

Time Frame

Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 13.00 to 15.99 years at time of baseline assessment Able to validly and safely complete baseline assessments All genders All races Eligibility as a subject with early life stress will be determined by: Scoring 4 or greater on Adverse Childhood Experiences (ACE) scale, with at least two experiences having occurred prior to age 10. Exclusion Criteria: 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, 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, or conduct disorder. Current active suicidal ideation. Current use of medications with major effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); ADHD medications and SSRIs, that have been stable for at least 6 weeks, are not exclusionary since their use is associated with conditions that confer risk for monitored disorders that emerge in adolescence, and assessment of these individuals will provide useful data to the scientific community. Youth on ADHD medications and SSRIs will not be asked to go off their medications. Not fluent in English 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. Youth / parent who are unable or unwilling to provide biological samples (i.e., blood draws or saliva collection). Female youth who are pregnant Youth who are currently in unsafe environments (e.g., currently living with an abusive parent)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Namik Kirlic, PhD

Organizational Affiliation

Laureate Institute for Brain Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laureate Institute for Brain Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33858395

Citation

Cohen ZP, Cosgrove KT, Akeman E, Coffey S, Teague K, Hays-Grudo J, Paulus MP, Aupperle RL, Kirlic N. The effect of a mindfulness-based stress intervention on neurobiological and symptom measures in adolescents with early life stress: a randomized feasibility study. BMC Complement Med Ther. 2021 Apr 15;21(1):123. doi: 10.1186/s12906-021-03295-1.

Results Reference

derived

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Mindfulness for Resilience in Early Life

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