Effects Of The Mindfulness Meditation Practices On Cognition

Phase 3

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Behavioral: Meditation; Behavioral: Active comparator (meditation) with healthy subjects

• Registration Number: NCT01738334
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Status Verified: 2012-11
• Study First Submitted: 2012-11-11
• Study First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-28
• Study First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meditation	Meditation	A Group of Patients with ADHD was participate of the meditation practices for eight weeks.
Healthy subjects	Active comparator (meditation) with healthy subjects	The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks.

Primary Outcome Measures

Name	Time	Method
Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.	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).
Evaluate the executive functions	1 day	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.	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).
Evaluate the quality of life before to the meditation and 8 weeks after to the meditation.	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).
Evaluate the attention before to the meditation and 8 weeks after to the meditation.	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).

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil