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Effects Of The Mindfulness Meditation Practices On Cognition

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Active comparator (meditation) with healthy subjects
Meditation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Meditation, Cognition, Attention Deficit Disorder with Hyperactivity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

Healthy subjects

Standby

Meditation

Arm Description

The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks.

The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks.

A Group of Patients with ADHD was participate of the meditation practices for eight weeks.

Outcomes

Primary Outcome Measures

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).
Evaluate the executive functions
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.
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.
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.
The scores of attention was evaluated by Continuous Performance Test (CPT) and the Attentional Network Test (ANT).

Secondary Outcome Measures

Full Information

First Posted
November 11, 2012
Last Updated
November 28, 2012
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01738334
Brief Title
Effects Of The Mindfulness Meditation Practices On Cognition
Official Title
EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Meditation, Cognition, Attention Deficit Disorder with Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks.
Arm Title
Standby
Arm Type
No Intervention
Arm Description
The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks.
Arm Title
Meditation
Arm Type
Experimental
Arm Description
A Group of Patients with ADHD was participate of the meditation practices for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Active comparator (meditation) with healthy subjects
Intervention Description
The control group with healthy subjects that was participate in meditation ("active" control group)
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Other Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.
Description
The symptoms of inattention and hyperactivity / impulsivity were evaluated by means the Adult self-report scale (ASRS).
Time Frame
change from baseline in ADHD symptoms at 8 weeks
Title
Evaluate the executive functions
Description
The executive functions tests were applied before to the meditation, so that to avoid learning.
Time Frame
1 day
Title
Evaluate the mood symptoms before to the meditation and 8 weeks after to the meditation.
Description
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).
Time Frame
change from baseline in mood symptoms at 8 weeks.
Title
Evaluate the quality of life before to the meditation and 8 weeks after to the meditation.
Description
Quality of Life was evaluated by means of the Questionnaire in Adults with ADHD (AAQoL).
Time Frame
change from baseline in quality of life at 8 weeks.
Title
Evaluate the attention before to the meditation and 8 weeks after to the meditation.
Description
The scores of attention was evaluated by Continuous Performance Test (CPT) and the Attentional Network Test (ANT).
Time Frame
change from baseline in attention at 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Pompéia, Postdoctoral
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Viviane F Bueno, Doctor
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil

12. IPD Sharing Statement

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Effects Of The Mindfulness Meditation Practices On Cognition

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