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Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

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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):

July 6, 2005
July 12, 2005
December 10, 2010
March 16, 2011
January 1, 2018
September 2004
July 2009   (Final data collection date for primary outcome measure)
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.
ADHD symptoms
Complete list of historical versions of study NCT00118911 on ClinicalTrials.gov Archive Site
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.
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Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
Efficacy of CBT for Residual ADHD in Adults
This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • 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)
  • 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)
  • Experimental: Cognitive-Behavioral Therapy
    Participants will receive cognitive-behavioral therapy following our protocol.
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
  • Active Comparator: Relaxation with Educational Support
    Applied relaxation plus educational support (RES).
    Intervention: Other: Relaxation techniques and education about ADHD
Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2010
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH069812( U.S. NIH Grant/Contract )
R01MH069812 ( U.S. NIH Grant/Contract )
2003-P-000523 ( Other Identifier: MGH IRB Protocol number )
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Steven A. Safren, National Institute of Mental Health (NIMH)
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
Massachusetts General Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP