Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

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

Detailed Description
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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.

Official Title
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Efficacy of CBT for Residual ADHD in Adults

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)
* Other: Relaxation techniques and education about ADHD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy<br>Participants will receive cognitive-behavioral therapy following our protocol. | Behavioral: Cognitive behavioral therapy (CBT)<br>* Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.<br>* Other names: Mastering Your Adult ADHD manual (Safren, et al., 2005);|
| Active Comparator: Relaxation with Educational Support<br>Applied relaxation plus educational support (RES). | Other: Relaxation techniques and education about ADHD<br>* Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.<br>* Other names: Unpublished treatment manual (Sprich, et al., 2003);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, ADHD, ADD, CBT, Relaxation Techniques, Education