Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00118911

Purpose

This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

Condition	Intervention
Attention Deficit Disorder With Hyperactivity	Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Relaxation techniques and education about ADHD

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of CBT for Residual ADHD in Adults

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

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

Primary Outcome Measures:

ADHD symptoms [ Time Frame: Measured at post-treatment and Months 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	September 2004
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive cognitive behavioral therapy.	Behavioral: Cognitive behavioral therapy (CBT) Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
2: Active Comparator Participants will receive applied relaxation plus educational support.	Behavioral: Relaxation techniques and education about ADHD Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.

Detailed Description:

Attention deficit hyperactivity disorder (ADHD), previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether cognitive behavioral therapy (CBT) is more effective than ADHD education and relaxation techniques in treating adults with ADHD.

Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or training in which they will learn relaxation techniques and receive detailed information about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry and at study completion.

The study is being conducted at Massachusetts General Hospital in Boston and requires 5 assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston on a weekly basis in order to participate in the study.

Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and relaxation techniques.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of adult ADHD of at least mild clinical severity (CGI score of 3 or greater)
Stable on medications for adult ADHD for at least 2 months
Between 18 and 65 years old
Be able to give informed consent and comply with study procedures

Exclusion Criteria:

Moderate to severe major depression, clinically significant panic disorder (CGI for depression or panic greater than 4), bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
Active suicidality (HAM-D suicidality item rated 3 or 4)
Current substance abuse or dependence
IQ less than 90
Suicide risk
Prior participation in cognitive behavioral therapy for ADHD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118911

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Steve A. Safren, PhD	Fenway Community Health
Study Director:	Susan Sprich, PhD	Partners Health Organization

More Information

No publications provided

Responsible Party:	National Institute of Mental Health ( John Hsiao/ Project Officer )
Study ID Numbers:	R01 MH69812, 2003-P-000523, DSIR 83-ATAS
Study First Received:	July 6, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00118911 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Adult
ADHD
ADD

CBT
Relaxation Techniques
Education

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:

Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on September 09, 2009