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Health Enhancement And Resilience Training (HEART)

22. januar 2021 opdateret af: University of California, San Francisco

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94118
        • University of California, San Francisco

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • mindfulness

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Salivary telomere length
Tidsramme: 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.
Change from beginning to end of 12-week intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychological Well-Being
Tidsramme: 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.
Change from beginning to end of 12-week intervention
Telomere length from blood cells
Tidsramme: 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.
Change over six months pre- and post-intervention
Telomerase
Tidsramme: 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.
Change over 6 months pre- and post-intervention
Cognitive functioning
Tidsramme: 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.
Change over six months pre- and post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Elissa S Epel, PhD, University of California, San Francisco
  • Ledende efterforsker: Elizabeth Blackburn, PhD, University of California, San Francisco
  • Ledende efterforsker: Jue Lin, PhD, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2013

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

10. juli 2013

Først indsendt, der opfyldte QC-kriterier

7. oktober 2013

Først opslået (Skøn)

9. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 10-02063

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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