Effects Of The Mindfulness Meditation Practices On Cognition
28. november 2012 oppdatert av: Viviane Freire Bueno, Federal University of São Paulo
EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional subsystems of alerting and conflict monitoring.
Mindfulness meditation may lead to an improvement of these deficits, and reduces symptoms of anxiety and depression.
However, the studies that demonstrated these improvements did not use a control group, nor controlled the use of medication.
In the present study the investigators will examine the effects of the mindfulness practices (same protocol of 8 weekly sessions used in the study that showed positive effects in this disorder) in the performance of adult patients and healthy people (with ADHD).
Cognitive performance, mood, and the quality of life will be assessed by validated questionnaires before and after treatment/standby.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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São Paulo, Brasil, 04023062
- Federal University of São Paulo
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Portuguese as their first language;
- minimum of eight years of formal education;
- normal vision or corrected to normal and normal hearing;
- no prior experience with meditation;
- patients should be taking stable doses of methylphenidate (for at least a month) for their disorder as prescribed by their doctors.
Exclusion Criteria:
- patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or Tourette's syndrome.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Healthy subjects
The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks.
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The control group with healthy subjects that was participate in meditation ("active" control group)
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Ingen inngripen: Standby
The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks.
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Eksperimentell: Meditation
A Group of Patients with ADHD was participate of the meditation practices for eight weeks.
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In the eight weeks following the first session of cognitive tests, the participants made a practice of weekly meditation group lasting 2 hours.
Practices with each group (patients and "active" controls) occurred on different days.
With regard to meditation practices were performed in a sitting posture with emphasis on daily life.
Each weekly session involved meditation practices with trained professional, practical proposals for home exercise and a discussion group.
Meditation compact discs (CDs)were given to participants for practices at home, which proposed activities for 5 minutes to 1 week and 2 weeks for 10 minutes 3-5, and finally 15 minutes for 6-8 weeks.
After 8 weeks of treatment the second session of tests was held that involved the same tasks in session 1.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.
Tidsramme: change from baseline in ADHD symptoms at 8 weeks
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The symptoms of inattention and hyperactivity / impulsivity were evaluated by means the Adult self-report scale (ASRS).
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change from baseline in ADHD symptoms at 8 weeks
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Evaluate the executive functions
Tidsramme: 1 day
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The executive functions tests were applied before to the meditation, so that to avoid learning.
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1 day
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Evaluate the mood symptoms before to the meditation and 8 weeks after to the meditation.
Tidsramme: change from baseline in mood symptoms at 8 weeks.
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The symptoms of anxiety and depression were evaluated by means of the following scales: Trait Anxiety Inventory (STAI-Trait), and Beck Depression Scale, respectively, and the visual-analog scales of mood (VAMS)and Positive and negative Affect Schedule extended (PANAS-X).
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change from baseline in mood symptoms at 8 weeks.
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Evaluate the quality of life before to the meditation and 8 weeks after to the meditation.
Tidsramme: change from baseline in quality of life at 8 weeks.
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Quality of Life was evaluated by means of the Questionnaire in Adults with ADHD (AAQoL).
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change from baseline in quality of life at 8 weeks.
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Evaluate the attention before to the meditation and 8 weeks after to the meditation.
Tidsramme: change from baseline in attention at 8 weeks.
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The scores of attention was evaluated by Continuous Performance Test (CPT) and the Attentional Network Test (ANT).
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change from baseline in attention at 8 weeks.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Sabine Pompéia, Postdoctoral, Federal University of São Paulo
- Hovedetterforsker: Viviane F Bueno, Doctor, Federal University of São Paulo
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2012
Primær fullføring (Faktiske)
1. februar 2012
Studiet fullført (Faktiske)
1. mai 2012
Datoer for studieregistrering
Først innsendt
11. november 2012
Først innsendt som oppfylte QC-kriteriene
28. november 2012
Først lagt ut (Anslag)
30. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. november 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. november 2012
Sist bekreftet
1. november 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EMC 001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .