Health Enhancement And Resilience Training

Not Applicable

Completed

• Conditions: Well-being; Stress; Aging
• Interventions: Behavioral: Stress-reduction class

• Registration Number: NCT01959126
• Lead Sponsor: University of California, San Francisco

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).

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress-reduction class	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.

Primary Outcome Measures

Name	Time	Method
Salivary telomere length	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 Outcome Measures

Name	Time	Method
Telomere length from blood cells	Change over six months pre- and post-intervention	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.
Psychological Well-Being	Change from beginning to end of 12-week intervention	We will collect perceived stress, acceptance and awareness of emotions and rumination at the beginning and at the end of the intervention.
Telomerase	Change over 6 months pre- and post-intervention	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.
Cognitive functioning	Change over six months pre- and post-intervention	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States