Health Experiences & Early Life Disadvantages

Study 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.

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

Conditions
-----------------
Early Life Adversity, Chronic Stress

Intervention / Treatment
-----------------
* Behavioral: Meditation Workshop


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lovingkindness<br>A six-week formal meditation workshop for 1 hour per week. | Behavioral: Meditation Workshop<br>* Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.<br>|
| Placebo Comparator: Mindfulness<br>A six-week formal meditation workshop for 1 hour per week. | Behavioral: Meditation Workshop<br>* Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte basal gene expression (evaluated through blood samples) | 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) | 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) | Monetary choice questionnaire to assess impulsive decision-making. | Week 0, Week 12 | 
| 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 |