Effects Of The Mindfulness Meditation Practices On Cognition

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Behavioral: Active comparator (meditation) with healthy subjects; Behavioral: Meditation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023062
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.	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	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.	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.	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.	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.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 11, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 28, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Meditation; Cognition; Attention Deficit Disorder with Hyperactivity
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: EMC 001