Effects Of The Mindfulness Meditation Practices On Cognition

NCT01738334 | Completed Phase 3 DMC

• 1 other identifier: EMC 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (3)

Healthy subjects

ACTIVE COMPARATOR

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

Behavioral: Active comparator (meditation) with healthy subjects

Standby

NO INTERVENTION

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

Meditation

EXPERIMENTAL

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

Behavioral: Meditation

Interventions

Active comparator (meditation) with healthy subjects BEHAVIORAL

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

Healthy subjects

Meditation 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.

Also known as: Mindfulness

Meditation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or Tourette's syndrome.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04023062, Brazil

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Meditation; Mindfulness

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy

Study Officials

• Sabine Pompéia, Postdoctoral

  Federal University of São Paulo

  STUDY DIRECTOR

• Viviane F Bueno, Doctor

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Sabine Pompéia)

Study Record Dates

• First Submitted: November 11, 2012
• First Posted: November 30, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

BR (1)