Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Drug therapy
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Adult, ADHD, ADD
Eligibility Criteria
Inclusion Criteria: Adult ADHD of at least moderate severity On current drug therapy for ADHD Exclusion Criteria: Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders Current substance abuse or dependence IQ less than 90 Suicide risk History of cognitive behavioral therapy
Sites / Locations
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
ADHD symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT00050050
First Posted
November 20, 2002
Last Updated
May 23, 2014
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00050050
Brief Title
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
Official Title
CBT for Residual ADHD Symptoms in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment.
Study hypothesis: CBT is an effective treatment for adult ADHD.
Detailed Description
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 CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies.
Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Adult, ADHD, ADD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Drug therapy
Primary Outcome Measure Information:
Title
ADHD symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult ADHD of at least moderate severity
On current drug therapy for ADHD
Exclusion Criteria:
Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
Current substance abuse or dependence
IQ less than 90
Suicide risk
History of cognitive behavioral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Safren, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
We'll reach out to this number within 24 hrs