Mindfulness for Resilience in Early Life (MindREaL)

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.

Study Overview

• Status: Completed
• Conditions: Resilience; Adolescent With Early Life Stress
• Intervention / Treatment: Behavioral: Mindfulness

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfulness; Mindfulness: Eight sessions, twice per week over four weeks. Surveys administered prior to each session.	Behavioral: Mindfulness; 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
No Intervention: Control; Treatment as usual (i.e., pharmacotherapy, psychotherapy, etc.) for the four week duration with twice weekly surveys administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline
Immune System Activity	Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood	Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborators: Oklahoma State University
• Investigators: Principal Investigator: Namik Kirlic, PhD, Laureate Institute for Brain Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): March 7, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent; Stress; Mindfulness; Resilience; Early life stress; Neurobiological
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: LIBR # 2018-003-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No