Effects Of The Mindfulness Meditation Practices On Cognition

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738334
• Other study ID #: EMC 001
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2012
• Last updated: November 28, 2012
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• Active comparator (meditation) with healthy subjects
The control group with healthy subjects that was participate in meditation ("active" control group)
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluate the executive functions	The executive functions tests were applied before to the meditation, so that to avoid learning.	1 day
Primary	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.
Primary	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.
Primary	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.