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Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven A. Safren, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00118911
First received: July 6, 2005
Last updated: March 7, 2013
Last verified: March 2013
  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)
Other: Relaxation techniques and education about ADHD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of CBT for Residual ADHD in Adults

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Post-treatment ADHD Symptoms [ Time Frame: post-treatment (after receiving 12 sessions of treatment) ] [ Designated as safety issue: No ]
    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:
  • Maintenance of Gains in CBT Condition [ Time Frame: 12 month follow-up (12 months after baseline assessment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: September 2004
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Massachusetts General Hospital
Investigators
Principal Investigator: Steve A. Safren, PhD Massachusetts General Hospital
Study Director: Susan Sprich, PhD Partners Health Organization
  More Information

Publications:
Responsible Party: Steven A. Safren, Principal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00118911     History of Changes
Other Study ID Numbers: R01 MH69812, R01MH069812, 2003-P-000523
Study First Received: July 6, 2005
Results First Received: December 10, 2010
Last Updated: March 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Adult
ADHD
ADD
CBT
Relaxation Techniques
Education

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014