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Clinical Trials/NCT01738334
NCT01738334
Completed
Phase 3

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

Federal University of São Paulo1 site in 1 country40 target enrollmentFebruary 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
Federal University of São Paulo
Enrollment
40
Locations
1
Primary Endpoint
Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
May 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Viviane Freire Bueno

Principal Investigator (Sabine Pompéia)

Federal University of São Paulo

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.

Outcomes

Primary Outcomes

Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.

Time Frame: 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

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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).

Study Sites (1)

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