Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven A. Safren, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00118911
First received: July 6, 2005
Last updated: March 7, 2013
Last verified: March 2013
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Behavioral: Cognitive behavioral therapy (CBT)
Other: Relaxation techniques and education about ADHD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited via clinics associated with Massachusetts General Hospital, local radio advertisements, advertisements posted throughout the hospital, as well as through referrals from other mental health professionals. The study was conducted between November, 2004 and June, 2008 (follow-up was conducted through July, 2009).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 138 individuals were consented and assessed for eligibility. Of these, 52 individuals were excluded prior to randomization (36 didn't meet inclusion criteria, 8 declined to participate, 6 were excluded for unknown reasons, and 2 were excluded for other reasons).

Reporting Groups
  Description
Cognitive-Behavioral Therapy (CBT) Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
Relaxation With Educational Support (RES) Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.

Participant Flow:   Overall Study
    Cognitive-Behavioral Therapy (CBT)     Relaxation With Educational Support (RES)  
STARTED     43     43  
Received Intervention as Assigned     41     38  
Completed Post-Treatment Assessment     41     37  
6 Month Follow-up     37     30  
12 Month Follow-up     38 [1]   32 [2]
COMPLETED     41     38  
NOT COMPLETED     2     5  
Withdrawal by Subject                 2                 5  
[1] 1 participant did not complete the 6 month follow-up but did complete the 12 month follow-up
[2] 2 participants did not complete the 6 month follow-up but did complete the 12 month follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cognitive-Behavioral Therapy (CBT) Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
Relaxation With Educational Support (RES) Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
Total Total of all reporting groups

Baseline Measures
    Cognitive-Behavioral Therapy (CBT)     Relaxation With Educational Support (RES)     Total  
Number of Participants  
[units: participants]
  43     43     86  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     43     43     86  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.3  ± 10.3     44  ± 12.2     43.15  ± 11.25  
Gender  
[units: participants]
     
Female     19     19     38  
Male     24     24     48  
Region of Enrollment  
[units: participants]
     
United States     43     43     86  



  Outcome Measures
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1.  Primary:   Post-treatment ADHD Symptoms   [ Time Frame: post-treatment (after receiving 12 sessions of treatment) ]

2.  Secondary:   Maintenance of Gains in CBT Condition   [ Time Frame: 12 month follow-up (12 months after baseline assessment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susan Sprich, Ph.D.
Organization: Massachusetts General Hospital
phone: 617-726-5991
e-mail: ssprich@partners.org


Publications of Results:

Responsible Party: Steven A. Safren, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00118911     History of Changes
Other Study ID Numbers: R01 MH69812, R01MH069812, 2003-P-000523
Study First Received: July 6, 2005
Results First Received: December 10, 2010
Last Updated: March 7, 2013
Health Authority: United States: Federal Government