search
Back to results

Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Relaxation techniques and education about ADHD
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Adult, ADHD, ADD, CBT, Relaxation Techniques, Education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-Behavioral Therapy

Relaxation with Educational Support

Arm Description

Participants will receive cognitive-behavioral therapy following our protocol.

Applied relaxation plus educational support (RES).

Outcomes

Primary Outcome Measures

Post-treatment ADHD Symptoms
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
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.

Full Information

First Posted
July 6, 2005
Last Updated
December 7, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00118911
Brief Title
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
Official Title
Efficacy of CBT for Residual ADHD in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2010 (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
Yes

5. Study Description

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.

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, CBT, Relaxation Techniques, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
Participants will receive cognitive-behavioral therapy following our protocol.
Arm Title
Relaxation with Educational Support
Arm Type
Active Comparator
Arm Description
Applied relaxation plus educational support (RES).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Other Intervention Name(s)
Mastering Your Adult ADHD manual (Safren, et al., 2005)
Intervention Description
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Intervention Type
Other
Intervention Name(s)
Relaxation techniques and education about ADHD
Other Intervention Name(s)
Unpublished treatment manual (Sprich, et al., 2003)
Intervention Description
Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.
Primary Outcome Measure Information:
Title
Post-treatment ADHD Symptoms
Description
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.
Time Frame
post-treatment (after receiving 12 sessions of treatment)
Secondary Outcome Measure Information:
Title
Maintenance of Gains in CBT Condition
Description
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.
Time Frame
12 month follow-up (12 months after baseline assessment)

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve A. Safren, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Sprich, PhD
Organizational Affiliation
Partners Health Organization
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20736471
Citation
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.
Results Reference
result

Learn more about this trial

Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

We'll reach out to this number within 24 hrs