Health Enhancement And Resilience Training

Aging Clinical Trial

— HEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959126
• Other study ID #: 10-02063
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Stress
• Well-being

Intervention

Behavioral:
• Stress-reduction class
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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