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Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00278473
  Purpose

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).


Condition Intervention
Attention Deficit Disorder With Hyperactivity
Behavioral: Cognitive Behavioral Group Treatment
Behavioral: Social Support Problem-Solving Group Treatment

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Meta-Cognitive Deficits in Adults With ADHD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Time management, organization and planning skills [ Time Frame: Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment ] [ Designated as safety issue: No ]
  • ADHD symptoms [ Time Frame: Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression symptoms [ Time Frame: Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment ] [ Designated as safety issue: No ]
  • Self-esteem [ Time Frame: Measured at Weeks 6 and 12 and Months 3 and 6 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: May 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1.: Experimental
Cognitive behavioral group
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.
2.: Active Comparator
Social support problem-solving group
Behavioral: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278473

Locations
United States, New York
The Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Investigators
Principal Investigator: Mary V. Solanto, PhD The Mount Sinai Medical Center
  More Information

Click here for the Mount Sinai Attention Deficit Hyperactivity Disorder Center website  This link exits the ClinicalTrials.gov site

Responsible Party: Mount Sinai School of Medicine ( Mary Solanto, PhD, Principal Investigator )
Study ID Numbers: R34 MH71721, DATR A2-AIR
Study First Received: January 13, 2006
Last Updated: December 30, 2008
ClinicalTrials.gov Identifier: NCT00278473  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Primarily Inattentive
Hyperactive Impulsive Type
Combined Type
ADHD
Adults
Psychological
CBT

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009