Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

NCT ID: NCT00118911

Last Updated: 2018-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive-Behavioral Therapy

Participants will receive cognitive-behavioral therapy following our protocol.

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

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

Relaxation with Educational Support

Applied relaxation plus educational support (RES).

Group Type ACTIVE_COMPARATOR

Relaxation techniques and education about ADHD

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavioral therapy (CBT)

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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mastering Your Adult ADHD manual (Safren, et al., 2005) Unpublished treatment manual (Sprich, et al., 2003)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steven A. Safren

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steve A. Safren, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Susan Sprich, PhD

Role: STUDY_DIRECTOR

Partners Health Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 20736471 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH069812

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2003-P-000523

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH069812

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Behavioral Therapy for Trichotillomania
NCT00740909 COMPLETED PHASE1/PHASE2
Treatment of Post-TBI Depression
NCT00211835 COMPLETED NA
Telehealth BPT in DBP Practice
NCT05301933 COMPLETED NA