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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.

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
cognitive computerized training
simple cognitive computerized training
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Executive functions, Quality of life

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cognitive computerized training

simple cognitive computerized training

Arm Description

cognitive computerized training utilizing executive attention tasks

simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention

Outcomes

Primary Outcome Measures

Executive functioning

Secondary Outcome Measures

ADHD symptomatology and quality of life

Full Information

First Posted
February 12, 2009
Last Updated
August 15, 2011
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00843141
Brief Title
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.
Official Title
ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Executive functions, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cognitive computerized training
Arm Type
Experimental
Arm Description
cognitive computerized training utilizing executive attention tasks
Arm Title
simple cognitive computerized training
Arm Type
Active Comparator
Arm Description
simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention
Intervention Type
Behavioral
Intervention Name(s)
cognitive computerized training
Intervention Description
cognitive computerized training utilizing executive attention tasks
Intervention Type
Behavioral
Intervention Name(s)
simple cognitive computerized training
Intervention Description
simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention
Primary Outcome Measure Information:
Title
Executive functioning
Time Frame
after 3 months of cognitive training
Secondary Outcome Measure Information:
Title
ADHD symptomatology and quality of life
Time Frame
after 3 months of cognitive training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Bonne, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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.

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