NCT00118911

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 16, 2011

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

4.8 years

First QC Date

July 6, 2005

Results QC Date

December 10, 2010

Last Update Submit

December 7, 2017

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

AdultADHDADDCBTRelaxation TechniquesEducation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maintenance of Gains in CBT Condition

    12 month follow-up (12 months after baseline assessment)

Study Arms (2)

Cognitive-Behavioral Therapy

EXPERIMENTAL

Participants will receive cognitive-behavioral therapy following our protocol.

Behavioral: Cognitive behavioral therapy (CBT)

Relaxation with Educational Support

ACTIVE COMPARATOR

Applied relaxation plus educational support (RES).

Other: Relaxation techniques and education about ADHD

Interventions

Cognitive behavioral therapy (CBT)BEHAVIORAL

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

Also known as: Mastering Your Adult ADHD manual (Safren, et al., 2005)
Cognitive-Behavioral Therapy
Relaxation techniques and education about ADHDOTHER

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

Also known as: Unpublished treatment manual (Sprich, et al., 2003)
Relaxation with Educational Support

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 20736471RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral TherapyRelaxation Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeutics

Results Point of Contact

Title
Susan Sprich, Ph.D.
Organization
Massachusetts General Hospital
ssprich@partners.org
617-726-5991

Study Officials

  • Steve A. Safren, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Susan Sprich, PhD

    Partners Health Organization

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 12, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

January 2, 2018

Results First Posted

March 16, 2011

Record last verified: 2017-12

Locations

US(1)