Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Efficacy of CBT for Residual ADHD in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118911
• Other study ID #: R01MH069812
• Secondary ID: R01MH0698122003-
• Status: Completed
• Phase: N/A
• First received: July 6, 2005
• Last updated: December 7, 2017
• Start date: September 2004
• Est. completion date: July 2010

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• Cognitive behavioral therapy (CBT)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	post-treatment (after receiving 12 sessions of treatment)
Secondary	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.	12 month follow-up (12 months after baseline assessment)