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Clinical Trials/NCT01959126
NCT01959126
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country70 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of California, San Francisco
Enrollment
70
Locations
1
Primary Endpoint
Salivary telomere length
Status
Completed
Last Updated
5 years ago

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).

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
November 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Salivary telomere length

Time Frame: Change from beginning to end of 12-week intervention

Participants will give saliva samples at the beginning and the end of the intervention. Salivary telomere length will be analyzed at both time points.

Secondary Outcomes

  • Telomere length from blood cells(Change over six months pre- and post-intervention)
  • Psychological Well-Being(Change from beginning to end of 12-week intervention)
  • Telomerase(Change over 6 months pre- and post-intervention)
  • Cognitive functioning(Change over six months pre- and post-intervention)

Study Sites (1)

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