Clinical trial NCT02400593: Health Experiences & Early Life Disadvantages
Official title: An Affective Intervention to Reverse the Biological Residue of Low Childhood SES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Life Adversity
Chronic Stress
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-03-27
Enrollment: 113
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Growing up in a low-income household has been shown to increase risk for, and susceptibility to many illnesses.The purpose of the study is to test an affective intervention for reversing biological risk factors, as related to childhood adversity, in midlife.

Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys, and two 30-minute surveys prior to each lab visit. During the lab visits, participants will have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse. Participants will also have their blood drawn.

All surveys and questionnaires inquire about participants' current demographics, family history, perceptions about life and well-being, physical health, and monetary choices.


Eligibility criteria: Inclusion Criteria:

* fluent in written and spoken English
* have daily access to internet and a computer

Exclusion Criteria:

* engaged in regular meditation practice, either recently or in the past
* previously participated in a meditation study
* have allergies to adhesive materials (includes latex)

Primary outcomes:
measure: Change in meditation time (Self-reported meditation time recorded daily)
timeFrame: Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12
Secondary outcomes:
measure: Leukocyte basal gene expression (evaluated through blood samples)
timeFrame: Week 0, Week 12
measure: Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)
timeFrame: Week 0, Week 12
measure: Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)
timeFrame: Week 0, Week 12
measure: Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)
timeFrame: Week 0, Week 12
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC PEP Lab
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Barbara L Fredrickson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller GE, Chen E, Fok AK, Walker H, Lim A, Nicholls EF, Cole S, Kobor MS. Low early-life social class leaves a biological residue manifested by decreased glucocorticoid and increased proinflammatory signaling. Proc Natl Acad Sci U S A. 2009 Aug 25;106(34):14716-21. doi: 10.1073/pnas.0902971106. Epub 2009 Jul 14.
citation: Cohen S, Doyle WJ, Turner RB, Alper CM, Skoner DP. Childhood socioeconomic status and host resistance to infectious illness in adulthood. Psychosom Med. 2004 Jul-Aug;66(4):553-8. doi: 10.1097/01.psy.0000126200.05189.d3.
citation: Miller GE, Chen E, Parker KJ. Psychological stress in childhood and susceptibility to the chronic diseases of aging: moving toward a model of behavioral and biological mechanisms. Psychol Bull. 2011 Nov;137(6):959-97. doi: 10.1037/a0024768.
citation: Cole SW, Hawkley LC, Arevalo JM, Cacioppo JT. Transcript origin analysis identifies antigen-presenting cells as primary targets of socially regulated gene expression in leukocytes. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3080-5. doi: 10.1073/pnas.1014218108. Epub 2011 Feb 7.
citation: Kok BE, Fredrickson BL. Upward spirals of the heart: autonomic flexibility, as indexed by vagal tone, reciprocally and prospectively predicts positive emotions and social connectedness. Biol Psychol. 2010 Dec;85(3):432-6. doi: 10.1016/j.biopsycho.2010.09.005. Epub 2010 Sep 22.
citation: West TN, Zhou J, Brantley MM, Kim SL, Brantley J, Salzberg S, Cole SW, Fredrickson BL. Effect of Mindfulness Versus Loving-kindness Training on Leukocyte Gene Expression in Midlife Adults Raised in Low-Socioeconomic Status Households. Mindfulness (N Y). 2022 May;13(5):1185-1196. doi: 10.1007/s12671-022-01857-z. Epub 2022 Mar 16.