- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01959126
Health Enhancement And Resilience Training (HEART)
The Effect of a Stress Reduction Program Using Mindfulness Techniques on Markers of Cellular Stress and Aging
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
California
-
San Francisco, California, Verenigde Staten, 94118
- University of California, San Francisco
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Salivary telomere length
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Psychological Well-Being
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Elissa S Epel, PhD, University of California, San Francisco
- Hoofdonderzoeker: Elizabeth Blackburn, PhD, University of California, San Francisco
- Hoofdonderzoeker: Jue Lin, PhD, University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 10-02063
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Stress-reduction class
-
Ege UniversityVoltooidPijn | Ongerustheid | StaarKalkoen
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); University of California, BerkeleyVoltooidAandachtstekortstoornis met hyperactiviteitVerenigde Staten
-
Amasya UniversityVoltooidOngerustheid | Zwangerschap gerelateerdKalkoen
-
Amasya UniversityVoltooidSpanning | Zwangerschap, hoog risicoKalkoen
-
Inonu UniversityVoltooidOngerustheid | Mindfulness | Werktevredenheid | Verloskundigen | Professionele burn-outKalkoen
-
Universidad Pontificia de SalamancaMinisterio de Ciencia e Innovación, SpainWervingOntstekingsreactie | Welzijn | Mentale gezondheid | Mindfulness | Cardiovasculaire gezondheid | ZelfcompassieSpanje
-
Zimmer BiometIngetrokkenDegeneratieve schijfziekteVerenigde Staten
-
Tel-Aviv Sourasky Medical CenterVoltooid
-
ElsanNog niet aan het werven
-
BCN CheckpointFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción... en andere medewerkersWervingHIV-infecties | Seksueel overdraagbare aandoeningen | Hiv/aids | Aanhankelijkheid, medicatie | Bijwerking van medicijnen | Vaccinatie | Profylaxe vóór blootstellingSpanje