Clinical trial NCT00118911: Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
Official title: Efficacy of CBT for Residual ADHD in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Adult
ADHD
ADD
CBT
Relaxation Techniques
Education
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-07-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-treatment ADHD Symptoms
timeFrame: post-treatment (after receiving 12 sessions of treatment)
Secondary outcomes:
measure: Maintenance of Gains in CBT Condition
timeFrame: 12 month follow-up (12 months after baseline assessment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: University of Miami
name: Steve A. Safren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Partners Health Organization
name: Susan Sprich, PhD
role: STUDY_DIRECTOR
References:
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.