Health Experiences & Early Life Disadvantages

Not Applicable

Completed

• Conditions: Early Life Adversity; Chronic Stress
• Interventions: Behavioral: Meditation Workshop

• Registration Number: NCT02400593
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Study Start: 2015-08
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lovingkindness	Meditation Workshop	A six-week formal meditation workshop for 1 hour per week.
Mindfulness	Meditation Workshop	A six-week formal meditation workshop for 1 hour per week.

Primary Outcome Measures

Name	Time	Method
Change in meditation time (Self-reported meditation time recorded daily)	Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12	Self-reported meditation time recorded daily.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UNC PEP Lab; 🇺🇸 Chapel Hill, North Carolina, United States