Clinical trial NCT01959126: Health Enhancement And Resilience Training
Official title: The Effect of a Stress Reduction Program Using Mindfulness Techniques on Markers of Cellular Stress and Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Aging
Well-being
Keywords: Telomerase
Telomere length
Psychological Sress
Mindfulness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Salivary telomere length
timeFrame: Change from beginning to end of 12-week intervention
Secondary outcomes:
measure: Psychological Well-Being
timeFrame: Change from beginning to end of 12-week intervention
measure: Telomere length from blood cells
timeFrame: Change over six months pre- and post-intervention
measure: Telomerase
timeFrame: Change over 6 months pre- and post-intervention
measure: Cognitive functioning
timeFrame: Change over six months pre- and post-intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elissa S Epel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elizabeth Blackburn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jue Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: