Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Adult, ADHD, ADD, CBT, Relaxation Techniques, Education
Brief summary
This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.
Detailed description
Attention deficit hyperactivity disorder (ADHD), previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether cognitive behavioral therapy (CBT) is more effective than ADHD education and relaxation techniques in treating adults with ADHD. Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or training in which they will learn relaxation techniques and receive detailed information about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry and at study completion. The study is being conducted at Massachusetts General Hospital in Boston and requires 5 assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston on a weekly basis in order to participate in the study. Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and relaxation techniques.
Interventions
BEHAVIORALCognitive behavioral therapy (CBT)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
OTHERRelaxation techniques and education about ADHD
Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment ADHD Symptoms | post-treatment (after receiving 12 sessions of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Gains in CBT Condition | 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. |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| Cognitive-Behavioral Therapy (CBT) Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. | 43 |
| Relaxation With Educational Support (RES) Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support. | 43 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Relaxation With Educational Support (RES) | Cognitive-Behavioral Therapy (CBT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 43 Participants | 86 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 12.2 | 42.3 years STANDARD_DEVIATION 10.3 | 43.15 years STANDARD_DEVIATION 11.25 |
| Region of Enrollment United States | 43 participants | 43 participants | 86 participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Post-treatment ADHD Symptoms | 14.46 units on a scale of symptom severity | Standard Deviation 8.46 |
| Relaxation With Educational Support (RES) | Post-treatment ADHD Symptoms | 19.19 units on a scale of symptom severity | Standard Deviation 9.71 |
Comparison: Hypothesis was that CBT would be superior to RESp-value: <0.0395% CI: [-8.3, -0.963]ANCOVA
Secondary
Maintenance of Gains in CBT Condition
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Maintenance of Gains in CBT Condition | 13.39 units on a scale of symptom severity | Standard Deviation 8.49 |
| Relaxation With Educational Support (RES) | Maintenance of Gains in CBT Condition | 16.97 units on a scale of symptom severity | Standard Deviation 10.72 |
Comparison: 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.p-value: >0.0595% CI: [-0.41, 0.18]Mixed Models Analysis