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Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00118911
Recruitment Status : Completed
First Posted : July 12, 2005
Results First Posted : March 16, 2011
Last Update Posted : January 1, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of CBT for Residual ADHD in Adults
Study Start Date : September 2004
Primary Completion Date : July 2009
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive-Behavioral Therapy
Participants will receive cognitive-behavioral therapy following our protocol.
Behavioral: Cognitive behavioral therapy (CBT)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Other Name: Mastering Your Adult ADHD manual (Safren, et al., 2005)
Active Comparator: Relaxation with Educational Support
Applied relaxation plus educational support (RES).
Other: 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.
Other Name: Unpublished treatment manual (Sprich, et al., 2003)

Outcome Measures

Primary Outcome Measures :
  1. Post-treatment ADHD Symptoms [ Time Frame: post-treatment (after receiving 12 sessions of treatment) ]
    ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.

Secondary Outcome Measures :
  1. Maintenance of Gains in CBT Condition [ Time Frame: 12 month follow-up (12 months after baseline assessment) ]
    maintenance of gains in CBT condition for those who responded or partially responded as measured by the ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118911

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Steve A. Safren, PhD University of Miami
Study Director: Susan Sprich, PhD Partners Health Organization
More Information

Responsible Party: Steven A. Safren, Principal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00118911     History of Changes
Other Study ID Numbers: R01MH069812 ( U.S. NIH Grant/Contract )
2003-P-000523 ( Other Identifier: MGH IRB Protocol number )
First Posted: July 12, 2005    Key Record Dates
Results First Posted: March 16, 2011
Last Update Posted: January 1, 2018
Last Verified: December 2017

Keywords provided by Steven A. Safren, National Institute of Mental Health (NIMH):
Relaxation Techniques

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms