Health Experiences & Early Life Disadvantages

Chronic Stress Clinical Trial

— HEELD  

Official title:

An Affective Intervention to Reverse the Biological Residue of Low Childhood SES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400593
• Other study ID #: 14-1938
• Secondary ID: R01AG048811
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: July 14, 2016
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Stress
• Early Life Adversity

Intervention

Behavioral:
• Meditation Workshop
Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

Locations

Country	Name	City	State
United States	UNC PEP Lab	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in meditation time (Self-reported meditation time recorded daily)	Self-reported meditation time recorded daily.	Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12	No
Secondary	Leukocyte basal gene expression (evaluated through blood samples)	Gene expression evaluated through blood samples.	Week 0, Week 12	No
Secondary	Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)	Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale.	Week 0, Week 12	No
Secondary	Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)	Monetary choice questionnaire to assess impulsive decision-making.	Week 0, Week 12	No
Secondary	Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)	Respiration and echocardiogram measured with respiration band and 2-lead electrode placement, respectively. Three-minute spontaneous breath followed by five minutes of paced breathing intervals.	Week 0, Week 12	No

External Links

•   Information for study and enrollment process.