Effects Of The Mindfulness Meditation Practices On Cognition

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Viviane Freire Bueno, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01738334
First received: November 11, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Behavioral: Active comparator (meditation) with healthy subjects
Behavioral: Meditation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation. [ Time Frame: change from baseline in ADHD symptoms at 8 weeks ] [ Designated as safety issue: Yes ]
    The symptoms of inattention and hyperactivity / impulsivity were evaluated by means the Adult self-report scale (ASRS).

  • Evaluate the executive functions [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    The executive functions tests were applied before to the meditation, so that to avoid learning.

  • Evaluate the mood symptoms before to the meditation and 8 weeks after to the meditation. [ Time Frame: change from baseline in mood symptoms at 8 weeks. ] [ Designated as safety issue: Yes ]
    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).

  • Evaluate the quality of life before to the meditation and 8 weeks after to the meditation. [ Time Frame: change from baseline in quality of life at 8 weeks. ] [ Designated as safety issue: Yes ]
    Quality of Life was evaluated by means of the Questionnaire in Adults with ADHD (AAQoL).

  • Evaluate the attention before to the meditation and 8 weeks after to the meditation. [ Time Frame: change from baseline in attention at 8 weeks. ] [ Designated as safety issue: Yes ]
    The scores of attention was evaluated by Continuous Performance Test (CPT) and the Attentional Network Test (ANT).


Enrollment: 40
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy subjects
The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks.
Behavioral: Active comparator (meditation) with healthy subjects
The control group with healthy subjects that was participate in meditation ("active" control group)
No Intervention: Standby
The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks.
Experimental: Meditation
A Group of Patients with ADHD was participate of the meditation practices for eight weeks.
Behavioral: Meditation
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.
Other Name: Mindfulness

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738334

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Sabine Pompéia, Postdoctoral Federal University of São Paulo
Principal Investigator: Viviane F Bueno, Doctor Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Viviane Freire Bueno, Principal Investigator (Sabine Pompéia), Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01738334     History of Changes
Other Study ID Numbers: EMC 001
Study First Received: November 11, 2012
Last Updated: November 28, 2012
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Meditation
Cognition
Attention Deficit Disorder with Hyperactivity

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014