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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH069812 | U.S. NIH Grant/Contract | View source | |
| 2003-P-000523 | Other Identifier | MGH IRB Protocol number |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Participants will receive cognitive-behavioral therapy following our protocol. |
|
| Relaxation with Educational Support | Active Comparator | Applied relaxation plus educational support (RES). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (CBT) | Behavioral | Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month follow-up (12 months after baseline assessment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve A. Safren, PhD | University of Miami | Principal Investigator |
| Susan Sprich, PhD | Partners Health Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20736471 | Result | 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. |
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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).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy (CBT) | Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. |
| FG001 | Relaxation With Educational Support (RES) | Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy (CBT) | Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. |
| BG001 | Relaxation With Educational Support (RES) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale of symptom severity | post-treatment (after receiving 12 sessions of treatment) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive-Behavioral Therapy (CBT) | Participants received 12 sessions of individual cognitive behavioral therapy following our protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Sprich, Ph.D. | Massachusetts General Hospital | 617-726-5991 | ssprich@partners.org |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
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| Relaxation techniques and education about ADHD | Other | Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms. |
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Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale of symptom severity | 12 month follow-up (12 months after baseline assessment) |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Relaxation With Educational Support (RES) | Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support. | 0 | 43 | 0 | 43 |
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| D000529 | Complementary Therapies |
| D013812 | Therapeutics |