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Completed

NCT Number: NCT00118911

Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.

Other names: Mastering Your Adult ADHD manual (Safren, et al., 2005)

Relaxation techniques and education about ADHD

Other

Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.

Other names: Unpublished treatment manual (Sprich, et al., 2003)

Primary outcomes

  1. Post-treatment ADHD Symptoms

    Time frame: post-treatment (after receiving 12 sessions of treatment)

    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 outcomes

  1. Maintenance of Gains in CBT Condition

    Time frame: 12 month follow-up (12 months after baseline assessment)

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Efficacy of CBT for Residual ADHD in Adults

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Jul 12, 2005
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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