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
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Behavioral: Cognitive behavioral therapy (CBT) Other: Relaxation techniques and education about ADHD||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of CBT for Residual ADHD in Adults|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2010|
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)
- 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.
- 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.
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|
|Principal Investigator:||Steve A. Safren, PhD||University of Miami|
|Study Director:||Susan Sprich, PhD||Partners Health Organization|