Attention Deficit Hyperactivity DisorderNCT00843141
The Efficacy of Computerized Cognitive Training in Adults With ADHD: Change in ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.
A study testing cognitive computerized training and simple cognitive computerized training in people with Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The study group of Adults with ADHD who will receive cognitive (executive attention) computerized training will show significant improvement in ADHD symptomatology,neuropsychological measures,daily functioning and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- cognitive computerized training and simple cognitive computerized training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Aug 2011
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (age 18-60);
- 9 years education;
- Diagnosis of ADHD;
- Executive function deficit in daily life;
- Signed informed consent.
Who cannot join
- Change in pharmacological treatment and/or received new treatment for ADHD in the last three months;
- Other current serious neurological disorder (e.g. epilepsy, brain injury, neurodegenerative disease), other major current and sever psychiatric disorder (axisI);
- Color blindness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.
The study group of Adults with ADHD who will receive cognitive (executive attention) computerized training will show significant improvement in ADHD symptomatology,neuropsychological measures,daily functioning and quality of life.
A significant difference will be found between the study group and the control group (adults with ADHD that will receive a simplified cognitive training program that does not challenge their executive functions)on the above measures.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- cognitive computerized training, simple cognitive computerized training
- Keywords
- ADHD, Executive functions, Quality of life
- 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.
cognitive computerized trainingBehavioural
cognitive computerized training utilizing executive attention tasks
simple cognitive computerized trainingBehavioural
simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention
| Study group | Role | What they receive |
|---|---|---|
| cognitive computerized training | Experimental | cognitive computerized training utilizing executive attention tasks Receives: Behavioral: cognitive computerized training |
| simple cognitive computerized training | Active comparator | simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention Receives: Behavioral: simple cognitive computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning
Measured: after 3 months of cognitive training
Secondary outcomes (1)
ADHD symptomatology and quality of life
Measured: after 3 months of cognitive training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Omer Bonne, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843141
- Sponsor's protocol ID
- ADHDA-HMO-CTIL
- Status last verified
- Feb 2009
- First submitted
- 12 Feb 2009
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.
- ClinicalTrials.gov ID
- NCT00843141
- Acronym / sponsor ID
- ADHDA-HMO-CTIL
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Executive functions, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Feb 2009 (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.
The study group of Adults with ADHD who will receive cognitive (executive attention) computerized training will show significant improvement in ADHD symptomatology,neuropsychological measures,daily functioning and quality of life.
A significant difference will be found between the study group and the control group (adults with ADHD that will receive a simplified cognitive training program that does not challenge their executive functions)on the above measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive computerized training | Experimental | Behavioral: cognitive computerized trainingcognitive computerized training utilizing executive attention tasks |
| simple cognitive computerized training | Active comparator | Behavioral: simple cognitive computerized trainingsimple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults (age 18-60);
- 9 years education;
- Diagnosis of ADHD;
- Executive function deficit in daily life;
- Signed informed consent.
Key exclusion criteria (3 listed)
- Change in pharmacological treatment and/or received new treatment for ADHD in the last three months;
- Other current serious neurological disorder (e.g. epilepsy, brain injury, neurodegenerative disease), other major current and sever psychiatric disorder (axisI);
- Color blindness.
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 |
|---|---|---|
| cognitive computerized trainingcognitive computerized training utilizing executive attention tasks | Behavioural | cognitive computerized training |
| simple cognitive computerized trainingsimple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention | Behavioural | simple cognitive computerized training |
Primary outcome
Executive functioning
Time frame: after 3 months of cognitive training
1 secondary outcome
ADHD symptomatology and quality of life
Time frame: after 3 months of cognitive training
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 16 Aug 2011.
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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.
Omer Bonne, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive computerized training and simple cognitive computerized training in people with Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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 16 Aug 2011. 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 Israel. 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.
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?
Executive functioning (time frame: after 3 months of cognitive training). 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 16 Aug 2011.