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.

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00843141
First received: February 12, 2009
Last updated: August 15, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: cognitive computerized training
Behavioral: simple cognitive computerized training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Executive functioning [ Time Frame: after 3 months of cognitive training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADHD symptomatology and quality of life [ Time Frame: after 3 months of cognitive training ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive computerized training
cognitive computerized training utilizing executive attention tasks
Behavioral: cognitive computerized training
cognitive computerized training utilizing executive attention tasks
Active Comparator: simple cognitive computerized training
simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention
Behavioral: simple cognitive computerized training
simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (age 18-60);
  • 9 years education;
  • Diagnosis of ADHD;
  • Executive function deficit in daily life;
  • Signed informed consent.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843141

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Omer Bonne, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Prof. Omer Bonne, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00843141     History of Changes
Other Study ID Numbers: ADHDA-HMO-CTIL
Study First Received: February 12, 2009
Last Updated: August 15, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
ADHD
Executive functions
Quality of life

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014