Mindfulness for Resilience in Early Life (MindREaL)

• ClinicalTrials.gov Identifier: NCT03633903
• Recruitment Status: Completed
• First Posted: August 16, 2018
• Results First Posted: August 19, 2021
• Last Update Posted: August 19, 2021
• Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborator: Oklahoma State University
• Information provided by (Responsible Party): Laureate Institute for Brain Research, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Adolescent With Early Life Stress; Resilience	Behavioral: Mindfulness	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Adolescents are randomly assigned to either a mindfulness intervention or no intervention.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Mindfulness for Resilience in Early Life
• Actual Study Start Date: July 12, 2018
• Actual Primary Completion Date: March 7, 2019
• Actual Study Completion Date: March 7, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Cortisol Reactivity [ Time Frame: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline ]
   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.
2. Immune System Activity [ Time Frame: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline ]
   Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood

Secondary Outcome Measures :

1. Mood and Feelings Questionnaire [ Time Frame: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline ]

   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.

Eligibility Criteria

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

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)

Contacts and Locations

Locations

United States, Oklahoma

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States, 74136

Sponsors and Collaborators

Laureate Institute for Brain Research, Inc.

Oklahoma State University

Investigators

• Principal Investigator: Namik Kirlic, PhD; Laureate Institute for Brain Research

  Study Documents (Full-Text)

Documents provided by Laureate Institute for Brain Research, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] May 31, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Laureate Institute for Brain Research, Inc.
• ClinicalTrials.gov Identifier: NCT03633903
• Other Study ID Numbers: LIBR # 2018-003-00
• First Posted: August 16, 2018
• Results First Posted: August 19, 2021
• Last Update Posted: August 19, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laureate Institute for Brain Research, Inc.:

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

Additional relevant MeSH terms:

Stress, Psychological; Behavioral Symptoms