Attention Deficit Disorder With HyperactivityPhase 3NCT01738334
Effects Of The Mindfulness Meditation Practices On Cognition
A Phase 3 study testing Active comparator (meditation) with healthy subjects and Meditation in people with Attention Deficit Disorder With Hyperactivity, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Active comparator (meditation) with healthy subjects and Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or Tourette's syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
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.
- Being tested
- Active comparator (meditation) with healthy subjects, Meditation
- Keywords
- Meditation, Cognition, Attention Deficit Disorder with Hyperactivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparator (meditation) with healthy subjectsBehavioural
The control group with healthy subjects that was participate in meditation ("active" control group)
MeditationBehavioural
Also called Mindfulness
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Active comparator | The "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks. Receives: 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. Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: change from baseline in attention at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Viviane Freire Bueno, Federal University of São Paulo
- Investigators
- Sabine Pompéia, Postdoctoral, Study director, Federal University of São PauloViviane F Bueno, Doctor, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738334
- Sponsor's protocol ID
- EMC 001
- Status last verified
- Nov 2012
- First submitted
- 11 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
- ClinicalTrials.gov ID
- NCT01738334
- Acronym / sponsor ID
- EMC 001
- Keywords
- Meditation, Cognition, Attention Deficit Disorder with Hyperactivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Active comparator | Behavioral: Active comparator (meditation) with healthy subjectsThe "active" control group of healthy individuals was subjected to the practice of meditation for eight weeks. |
| Standby | No intervention | –The control group of participants (patients and healthy subjects) who was not practice anything for eight weeks. |
| Meditation | Experimental | Behavioral: MeditationA Group of Patients with ADHD was participate of the meditation practices for eight weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or Tourette's syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active comparator (meditation) with healthy subjectsThe control group with healthy subjects that was participate in meditation ("active" control group) | Behavioural | Healthy subjects |
| MeditationAlso: MindfulnessIn 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. | Behavioural | Meditation |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Pompéia, Postdoctoral study director
Federal University of São Paulo
Viviane F Bueno, Doctor principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active comparator (meditation) with healthy subjects and Meditation in people with Attention Deficit Disorder With Hyperactivity, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.