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Completed

NCT Number: NCT01738334

Effects Of The Mindfulness Meditation Practices On Cognition

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of São Paulo

São Paulo, 04023062, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active comparator (meditation) with healthy subjects

Behavioral

The control group with healthy subjects that was participate in meditation ("active" control group)

Meditation

Behavioral

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 names: Mindfulness

Primary outcomes

  1. 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

    The symptoms of inattention and hyperactivity / impulsivity were evaluated by means the Adult self-report scale (ASRS).

  2. Evaluate the executive functions

    Time frame: 1 day

    The executive functions tests were applied before to the meditation, so that to avoid learning.

  3. 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.

    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).

  4. 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.

    Quality of Life was evaluated by means of the Questionnaire in Adults with ADHD (AAQoL).

  5. Evaluate the attention before to the meditation and 8 weeks after to the meditation.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2012
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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