Mindfulness for Resilience in Early Life

NCT03633903 | Completed Results DMC

• 1 other identifier: LIBR # 2018-003-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent With Early Life Stress; Resilience

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Mood and Feelings Questionnaire

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

Study Arms (2)

Mindfulness

ACTIVE COMPARATOR

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

Behavioral: Mindfulness

Control

NO INTERVENTION

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

Interventions

Mindfulness BEHAVIORAL

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

Mindfulness

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• Oklahoma State University: collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (1)

• 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.

  PMID: 33858395 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Namik Kirlic, PhD
• Organization: Laureate Institute for Brain Research

nkirlic@laureateinstitute.org

918-502-5747

Study Officials

• Namik Kirlic, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 16, 2018
• Study Start: July 12, 2018
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)