- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01738334
Effects Of The Mindfulness Meditation Practices On Cognition
28. november 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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São Paulo, Brasilien, 04023062
- Federal University of São Paulo
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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
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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 indgriben: Standby
The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks.
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Eksperimentel: 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 navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Sabine Pompéia, Postdoctoral, Federal University of São Paulo
- Ledende efterforsker: Viviane F Bueno, Doctor, Federal University of São Paulo
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
1. februar 2012
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. maj 2012
Datoer for studieregistrering
Først indsendt
11. november 2012
Først indsendt, der opfyldte QC-kriterier
28. november 2012
Først opslået (Skøn)
30. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EMC 001
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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