NCT00050050

Brief Summary

This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment. Study hypothesis: CBT is an effective treatment for adult ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2002

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1.9 years

First QC Date

November 20, 2002

Last Update Submit

May 23, 2014

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

AdultADHDADD

Outcome Measures

Primary Outcomes (1)

  • ADHD symptoms

Interventions

Cognitive behavioral therapyBEHAVIORAL
Drug therapyDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ADHD of at least moderate severity
  • On current drug therapy for ADHD

You may not qualify if:

  • Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
  • Current substance abuse or dependence
  • IQ less than 90
  • Suicide risk
  • History of cognitive behavioral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral TherapyDrug Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeutics

Study Officials

  • Steven A. Safren, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Behavioral Medicine

Study Record Dates

First Submitted

November 20, 2002

First Posted

November 21, 2002

Study Start

September 1, 2001

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)