ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00118911
Recruitment Status : Completed
First Posted : July 12, 2005
Results First Posted : March 16, 2011
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven A. Safren, National Institute of Mental Health (NIMH)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Disorder With Hyperactivity
Interventions Behavioral: Cognitive behavioral therapy (CBT)
Other: Relaxation techniques and education about ADHD
Enrollment 86

Recruitment Details 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 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).
Arm/Group Title Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Hide Arm/Group Description Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES) Total
Hide Arm/Group Description Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support. Total of all reporting groups
Overall Number of Baseline Participants 43 43 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
43
 100.0%
86
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 43 participants 86 participants
42.3  (10.3) 44  (12.2) 43.15  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Female
19
  44.2%
19
  44.2%
38
  44.2%
Male
24
  55.8%
24
  55.8%
48
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 43 participants 86 participants
43 43 86
1.Primary Outcome
Title Post-treatment ADHD Symptoms
Hide Description 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.
Time Frame post-treatment (after receiving 12 sessions of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on intent to treat. We used mixed-effect modeling which automatically imputes data using the slope up to the point of discontinuation.
Arm/Group Title Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Hide Arm/Group Description:
Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale of symptom severity
14.46  (8.46) 19.19  (9.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive-Behavioral Therapy (CBT)
Comments Hypothesis was that CBT would be superior to RES
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.03
Comments [Not Specified]
Method ANCOVA
Comments We used multiple imputation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.631
Confidence Interval (2-Sided) 95%
-8.30 to -0.963
Parameter Dispersion
Type: Standard Deviation
Value: 7.337
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Maintenance of Gains in CBT Condition
Hide Description 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.
Time Frame 12 month follow-up (12 months after baseline assessment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Hide Arm/Group Description:
Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale of symptom severity
13.39  (8.49) 16.97  (10.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive-Behavioral Therapy (CBT)
Comments We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.12
Confidence Interval (2-Sided) 95%
-.41 to .18
Parameter Dispersion
Type: Standard Deviation
Value: .59
Estimation Comments Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Hide Arm/Group Description Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
All-Cause Mortality
Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cognitive-Behavioral Therapy (CBT) Relaxation With Educational Support (RES)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
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
Responsible Party: Steven A. Safren, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00118911     History of Changes
Other Study ID Numbers: R01MH069812 ( U.S. NIH Grant/Contract )
R01MH069812 ( U.S. NIH Grant/Contract )
2003-P-000523 ( Other Identifier: MGH IRB Protocol number )
First Submitted: July 6, 2005
First Posted: July 12, 2005
Results First Submitted: December 10, 2010
Results First Posted: March 16, 2011
Last Update Posted: January 2, 2018