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Clinical Trials/NCT02400593
NCT02400593
Completed
N/A

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

University of North Carolina, Chapel Hill1 site in 1 country113 target enrollmentAugust 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Early Life Adversity
Sponsor
University of North Carolina, Chapel Hill
Enrollment
113
Locations
1
Primary Endpoint
Change in meditation time (Self-reported meditation time recorded daily)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara L. Fredrickson, PhD

Kenan Distinguished Professor

University of North Carolina, Chapel Hill

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)

Outcomes

Primary Outcomes

Change in meditation time (Self-reported meditation time recorded daily)

Time Frame: Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12

Self-reported meditation time recorded daily.

Secondary Outcomes

  • Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)(Week 0, Week 12)
  • Leukocyte basal gene expression (evaluated through blood samples)(Week 0, Week 12)
  • Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)(Week 0, Week 12)
  • Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)(Week 0, Week 12)

Study Sites (1)

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