Effects Of The Mindfulness Meditation Practices On Cognition

NCT ID: NCT01738334

Last Updated: 2012-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-05-31

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Meditation; Cognition; Attention Deficit Disorder with Hyperactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy subjects

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

Group Type: ACTIVE_COMPARATOR

Active comparator (meditation) with healthy subjects

Intervention Type: BEHAVIORAL

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

Standby

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Meditation

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

Group Type: EXPERIMENTAL

Meditation

Intervention Type: 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.

Interventions

Active comparator (meditation) with healthy subjects

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Mindfulness

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Viviane Freire Bueno

Principal Investigator (Sabine Pompéia)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Pompéia, Postdoctoral

Role: STUDY_DIRECTOR

Federal University of São Paulo

Viviane F Bueno, Doctor

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EMC 001

Identifier Type: -

Identifier Source: org_study_id