- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01738334
Effects Of The Mindfulness Meditation Practices On Cognition
28 november 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
São Paulo, Brasilien, 04023062
- Federal University of São Paulo
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Healthy subjects
The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks.
|
The control group with healthy subjects that was participate in meditation ("active" control group)
|
|
Inget ingripande: Standby
The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks.
|
|
|
Experimentell: Meditation
A Group of Patients with ADHD was participate of the meditation practices for eight weeks.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.
Tidsram: change from baseline in ADHD symptoms at 8 weeks
|
The symptoms of inattention and hyperactivity / impulsivity were evaluated by means the Adult self-report scale (ASRS).
|
change from baseline in ADHD symptoms at 8 weeks
|
|
Evaluate the executive functions
Tidsram: 1 day
|
The executive functions tests were applied before to the meditation, so that to avoid learning.
|
1 day
|
|
Evaluate the mood symptoms before to the meditation and 8 weeks after to the meditation.
Tidsram: change from baseline in mood symptoms at 8 weeks.
|
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).
|
change from baseline in mood symptoms at 8 weeks.
|
|
Evaluate the quality of life before to the meditation and 8 weeks after to the meditation.
Tidsram: change from baseline in quality of life at 8 weeks.
|
Quality of Life was evaluated by means of the Questionnaire in Adults with ADHD (AAQoL).
|
change from baseline in quality of life at 8 weeks.
|
|
Evaluate the attention before to the meditation and 8 weeks after to the meditation.
Tidsram: change from baseline in attention at 8 weeks.
|
The scores of attention was evaluated by Continuous Performance Test (CPT) and the Attentional Network Test (ANT).
|
change from baseline in attention at 8 weeks.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Sabine Pompéia, Postdoctoral, Federal University of São Paulo
- Huvudutredare: Viviane F Bueno, Doctor, Federal University of São Paulo
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2012
Primärt slutförande (Faktisk)
1 februari 2012
Avslutad studie (Faktisk)
1 maj 2012
Studieregistreringsdatum
Först inskickad
11 november 2012
Först inskickad som uppfyllde QC-kriterierna
28 november 2012
Första postat (Uppskatta)
30 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 november 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 november 2012
Senast verifierad
1 november 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EMC 001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .