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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00278473
Other study ID # R34MH071721
Secondary ID DATR A2-AIR
Status Active, not recruiting
Phase N/A
First received January 13, 2006
Last updated December 30, 2008
Start date May 2005
Est. completion date December 2008

Study information

Verified date November 2008
Source National Institute of Mental Health (NIMH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with attention deficit hyperactivity disorder (ADHD).


Description:

ADHD is a chronic neurobiological condition that affects people of all ages, genders, and races. Symptoms of ADHD may include, but are not limited to, the following: poor attention span; physical restlessness or hyperactivity; excessive impulsivity; chronic procrastination; frequently losing things; poor organization, planning, and time management skills; and excessive forgetfulness. Not every person with ADHD exhibits all of these symptoms, and the severity of the disorder can range from mild to severe. While there is no cure for ADHD, the condition can be managed with an accurate diagnosis and proper treatment. Left untreated, individuals with ADHD may experience significant impairment in social, emotional, occupational, and academic functioning. Stimulant and non-stimulant medications are usually effective in alleviating symptoms of ADHD in adults. However, some research suggests that medications may not effectively treat self-management functioning problems and that as many as one-third of adults with ADHD have inadequate responses to medication treatment. Additional research on the benefits of psychosocial treatments for ADHD in adults is needed. This study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with ADHD.

Individuals interested in participating in this study will first undergo an assessment of their eligibility for inclusion in the study. The assessment will last approximately 6 hours, but can be broken up into as many as 4 separate visits. Eligible participants will be randomly assigned to either receive group cognitive-behavioral therapy or join a problem-solving social support group. Both groups will meet once a week for 12 weeks. Each session will last roughly 2 hours and will focus on building time management, organizational, and planning skills. Time management, planning, and organizational skill levels will be assessed at the treatment mid-point, immediately following the intervention, and at 3 and 6 months following the treatment. Self-esteem and symptoms of depression and anxiety will also be measured at these visits.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Suspected of having or have been diagnosed with ADHD

- May potentially benefit from the ADHD group treatment

Exclusion Criteria:

- Any overt cognitive disability (e.g., Alzheimer's disease, mental retardation)

- Deemed not to potentially benefit from the proposed ADHD group treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Behavioral:
Cognitive Behavioral Group Treatment
Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
Social Support Problem-Solving Group Treatment
Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.

Locations

Country Name City State
United States The Mount Sinai Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time management, organization and planning skills Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment No
Primary ADHD symptoms Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment No
Secondary Depression symptoms Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment No
Secondary Anxiety Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment No
Secondary Self-esteem Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment No
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