Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 2, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven A. Safren, National Institute of Mental Health (NIMH)

Tracking Information
First Submitted Date  ICMJE July 6, 2005
First Posted Date  ICMJE July 12, 2005
Results First Submitted Date  ICMJE December 10, 2010
Results First Posted Date  ICMJE March 16, 2011
Last Update Posted Date January 2, 2018
Study Start Date  ICMJE September 2004
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2005)
ADHD symptoms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
Official Title  ICMJE Efficacy of CBT for Residual ADHD in Adults
Brief Summary This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2011)
86
Original Enrollment  ICMJE
 (submitted: July 8, 2005)
72
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118911
Other Study ID Numbers  ICMJE R01MH069812( U.S. NIH Grant/Contract )
R01MH069812 ( U.S. NIH Grant/Contract )
2003-P-000523 ( Other Identifier: MGH IRB Protocol number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven A. Safren, National Institute of Mental Health (NIMH)
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Steve A. Safren, PhD University of Miami
Study Director: Susan Sprich, PhD Partners Health Organization
PRS Account Massachusetts General Hospital
Verification Date December 2017

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