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OpenTrials
Completed

NCT Number: NCT02400593

Health Experiences & Early Life Disadvantages

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.

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Key information

Conditions

Early Life Adversity Chronic Stress

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC PEP Lab

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Meditation Workshop

Behavioral

Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

Primary outcomes

  1. 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

  1. Leukocyte basal gene expression (evaluated through blood samples)

    Time frame: Week 0, Week 12

    Gene expression evaluated through blood samples.

  2. Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)

    Time frame: Week 0, Week 12

    Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale.

  3. Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)

    Time frame: Week 0, Week 12

    Monetary choice questionnaire to assess impulsive decision-making.

  4. Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)

    Time frame: Week 0, Week 12

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: HEELD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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