Trial Outcomes & Findings for Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder (NCT NCT00118911)
NCT ID: NCT00118911
Last Updated: 2018-01-02
Results Overview
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.
COMPLETED
NA
86 participants
post-treatment (after receiving 12 sessions of treatment)
2018-01-02
Participant Flow
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).
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).
Participant milestones
| Measure |
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Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
Received Intervention as Assigned
|
41
|
38
|
|
Overall Study
Completed Post-Treatment Assessment
|
41
|
37
|
|
Overall Study
6 Month Follow-up
|
37
|
30
|
|
Overall Study
12 Month Follow-up
|
38
|
32
|
|
Overall Study
COMPLETED
|
41
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
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Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
Baseline Characteristics
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
Cognitive-Behavioral Therapy (CBT)
n=43 Participants
Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
|
Relaxation With Educational Support (RES)
n=43 Participants
Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
44 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
43.15 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-treatment (after receiving 12 sessions of treatment)Population: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy (CBT)
n=43 Participants
Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
|
Relaxation With Educational Support (RES)
n=43 Participants
Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
|
|---|---|---|
|
Post-treatment ADHD Symptoms
|
14.46 units on a scale of symptom severity
Standard Deviation 8.46
|
19.19 units on a scale of symptom severity
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: 12 month follow-up (12 months after baseline assessment)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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy (CBT)
n=43 Participants
Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
|
Relaxation With Educational Support (RES)
n=43 Participants
Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
|
|---|---|---|
|
Maintenance of Gains in CBT Condition
|
13.39 units on a scale of symptom severity
Standard Deviation 8.49
|
16.97 units on a scale of symptom severity
Standard Deviation 10.72
|
Adverse Events
Cognitive-Behavioral Therapy (CBT)
Relaxation With Educational Support (RES)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place