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Completed

NCT Number: NCT01959126

Health Enhancement And Resilience Training

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.

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Key information

Conditions

Stress Aging Well-Being

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress-reduction class

Behavioral

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.

Other names: mindfulness

Primary outcomes

  1. 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

  1. Psychological Well-Being

    Time frame: 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.

  2. Telomere length from blood cells

    Time frame: 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.

  3. Telomerase

    Time frame: 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.

  4. Cognitive functioning

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: HEART

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2013
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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