Health Enhancement And Resilience Training

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to examine whether a stress reduction intervention can improve health, mood and biological markers of cellular stress and aging in a group of chronically-stressed maternal caregivers and healthy maternal controls.

Detailed Description
-----------------
This stress-reduction intervention was added into an ongoing observational study in May of 2013. The parent study is a prospective cohort study of the effects of chronic stress in a group of maternal caregivers with children on the autism spectrum and healthy controls whose children have no diagnosis. Study participants are being invited to enroll in a 12-week stress reduction course based on the principles of mindfulness. They will attend four six-hour workshops and participate in 12 weekly hour-long web video conferencing calls to reinforce what is taught in the workshops. At the beginning and the end of the intervention, they complete self-report measures of psychological well-being and give saliva samples. Since the women are also participating in the longitudinal study, we have other before and after data for them. These include psycho-social measures, body measurements, psycho-physiology measurements, cognitive tests, actigraphy (for sleep), as well as saliva (for hormones), hair (for hormones) and blood (for telomeres, telomerase, gene expression, circulating hormones, inflammation and oxidative stress).

Official Title
-----------------
The Effect of a Stress Reduction Program Using Mindfulness Techniques on Markers of Cellular Stress and Aging

Conditions
-----------------
Stress, Aging, Well-being

Intervention / Treatment
-----------------
* Behavioral: Stress-reduction class


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have at least one child between 2 and 16 at time of enrollment Caregivers must have a child diagnosed in that age range diagnosed with an autism spectrum disorder. Controls must have a healthy child in that age range. All women must be Exclusion Criteria: Chronic disease, including recent history of cancer History of psychiatric disorder, such as bipolar disorder or post-traumatic stress disorder Medications, including statins, anti-anxiety drugs, and for controls only anti-depressants.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress-reduction class<br>Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness. They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops. We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment. | Behavioral: Stress-reduction class<br>* Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness. They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops. We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment. Both groups received similar instruction.<br>* Other names: mindfulness;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary telomere length | Participants will give saliva samples at the beginning and the end of the intervention. Salivary telomere length will be analyzed at both time points. | Change from beginning to end of 12-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Well-Being | We will collect perceived stress, acceptance and awareness of emotions and rumination at the beginning and at the end of the intervention. | Change from beginning to end of 12-week intervention | 
| Telomere length from blood cells | Since participants are also taking part in an ongoing non-interventional longitudinal study, they will provide blood samples at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention. We will measure telomere length pre- and post-intervention in a variety of blood cell types. | Change over six months pre- and post-intervention | 
| Telomerase | Since participants are also taking part in an ongoing non-interventional longitudinal study, they will provide blood samples at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention. We will measure telomerase pre- and post-intervention in a variety of blood cell types. | Change over 6 months pre- and post-intervention | 
| Cognitive functioning | Since participants are also taking part in an ongoing non-interventional longitudinal study, they will complete a battery of cognitive tasks at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention. We will be able to assess performance pre- and post-intervention, to see if it improves after the stress-reduction training. | Change over six months pre- and post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telomerase, Telomere length, Psychological Sress, Mindfulness